Arterial Access Complications Following Percutaneous Femoral Access in 24-Hour Resuscitative Endovascular Balloon Occlusion of the Aorta Survivors.

INTRODUCTION: With the use of resuscitative endovascular balloon occlusion of the aorta (REBOA) comes the potential for vascular access site complications (VASCs) and limb ischemic sequelae. We aimed to determine the prevalence of VASC and associated clinical and technical factors. METHODS: A retrospective cohort analysis of 24-h survivors undergoing percutaneous REBOA via the femoral artery in the American Association for the Surgery of Trauma Aortic Occlusion for Resuscitation in Trauma and Acute care surgery registry between Oct 2013 and Sep 2021 was performed. The primary outcome was VASC, defined as at least one of the following: hematoma, pseudoaneurysm, arteriovenous fistula, arterial stenosis, or the use of patch angioplasty for arterial closure. Associated clinical and procedural variables were examined. Data were analyzed using Fisher exact test, Mann-Whitney-U tests, and linear regression. RESULTS: There were 34 (7%) cases with VASC among 485 meeting inclusion criteria. Hematoma (40%) was the most common, followed by pseudoaneurysm (26%) and patch angioplasty (21%). No differences in demographics or injury/shock severity were noted between cases with and without VASC. The use of ultrasound (US) was protective (VASC, 35% versus no VASC, 51%; P = 0.05). The VASC rate in US cases was 12/242 (5%) versus 22/240 (9.2%) without US. Arterial sheath size >7 Fr was not associated with VASC. US use increased over time (R2 = 0.94, P < 0.001) with a stable rate of VASC (R2 = 0.78, P = 0.61). VASC were associated with limb ischemia (VASC, 15% versus no VASC, 4%; P = 0.006) and arterial bypass procedures (VASC 3% versus no VASC 0%; P < 0.001) but amputation was uncommon (VASC, 3% versus no VASC, 0.4%; P = 0.07). CONCLUSIONS: Percutaneous femoral REBOA had a 7% VASC rate which was stable over time. VASC are associated with limb ischemia but need for surgical intervention and/or amputation is rare. The use of US-guided access appears to be protective against VASC and is recommended for use in all percutaneous femoral REBOA procedures.

Antithrombin Activity Is Associated with Persistent Thromboinflammation and Mortality in Patients with Severe COVID-19 Illness.

INTRODUCTION: Severe COVID-19 illness can lead to thrombotic complications, organ failure, and death. Antithrombin (AT) regulates thromboinflammation and is a key component of chemical thromboprophylaxis. Our goal was to examine the link between AT activity and responsiveness to thromboprophylaxis, markers of hypercoagulability, and inflammation among severe COVID-19 patients. METHODS: This was a single-center, prospective observational study enrolling SARS-CoV-2-positive patients admitted to the intensive care unit on prophylactic enoxaparin. Blood was collected daily for 7 days to assess AT activity and anti-factor Xa levels. Patient demographics, outcomes, and hospital laboratory results were collected. Continuous variables were compared using Mann-Whitney tests, and categorical variables were compared using χ2 tests. Multivariable logistic regression was used to determine the association between AT activity and mortality. RESULTS: In 36 patients, 3 thromboembolic events occurred, and 18 (50%) patients died. Patients who died had higher fibrinogen, D-dimer, and C-reactive protein (CRP) levels and lower AT activity. Reduced AT activity was independently associated with mortality and correlated with both markers of hypercoagulability (D-dimer) and inflammation (CRP). CONCLUSION: Low AT activity is associated with mortality and persistent hypercoagulable and proinflammatory states in severe COVID-19 patients. The anti-thromboinflammatory properties of AT make it an appealing therapeutic target for future studies.

Prospective Observational Evaluation of the ER-REBOA Catheter at 6 U.S. Trauma Centers.

OBJECTIVE: To describe the current use of the ER-REBOA catheter and associated outcomes and complications. INTRODUCTION: Noncompressible truncal hemorrhage is the leading cause of potentially preventable death in trauma patients. Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a novel strategy to obtain earlier temporary hemorrhage control, supporting cardiac, and cerebral perfusion before definitive hemostasis. METHODS: Prospective, observational study conducted at 6 Level 1 Trauma Centers over 12-months. Inclusion criteria were age >15 years of age with evidence of truncal hemorrhage below the diaphragm and decision for emergent hemorrhage control intervention within 60 minutes of arrival. REBOA details, demographics, mechanism of injury, complications, and outcomes were collected. RESULTS: A total of 8166 patients were screened for enrollment. In 75, REBOA was utilized for temporary hemorrhage control. Blunt injury occurred in 80% with a median injury severity score (ISS) 34 (21, 43). Forty-seven REBOAs were placed in Zone 1 and 28 in Zone 3. REBOA inflation increased systolic blood pressure from 67 (40, 83) mm Hg to 108 (90, 128) mm Hg 5 minutes after inflation (P = 0.02). Cardiopulmonary resuscitation was ongoing during REBOA insertion in 17 patients (26.6%) and 10 patients (58.8%) had return of spontaneous circulation after REBOA inflation. The procedural complication rate was 6.6%. Overall mortality was 52%. CONCLUSION: REBOA can be used in blunt and penetrating trauma patients, including those in arrest. Balloon inflation uniformly improved hemodynamics and was associated with a 59% rate of return of spontaneous circulation for patients in arrest. Use of the ER-REBOA catheter is technically safe with a low procedural complication rate.

Evaluation of Noninvasive Hemoglobin Measurements in Trauma Patients: A Repeat Study.

INTRODUCTION: Reliable, accurate, and non-invasive hemoglobin measurements would be useful in the trauma setting. The aim of this study was to re-examine the ability of the Masimo Radical 7 in this setting after recent hardware and software improvements. METHODS: Level 1 Trauma patients were prospectively enrolled in the study over a 9-mo period with the goal of obtaining 3 paired data points from 150 patients admitted to the ICU or IMU. Hospital laboratory hemoglobin values were compared with cyanomethemoglobin (HiCN) and Masimo device hemoglobin (SpHb) values using comparison plots and Bland-Altman analysis. RESULTS: A total of 380 patients were enrolled in the study with 150 of those being admitted to the ICU or IMU. Comparison of hospital lab hemoglobin and HiCN (n = 494) found a correlation of R2 = 0.92. Comparison of hospital lab hemoglobin and Masimo device hemoglobin (n = 218) found a correlation of R2 = 0.27. Bland-Altman analysis of the 218 of the comparable hospital hemoglobin and Masimo device hemoglobin values had a bias of 0.505 g/dL with 95% of values within the limits of agreement of 4.06 g/dL to -3.60 g/dL. CONCLUSIONS: The Masimo Radical 7 device has the potential to provide timely, useful clinical information, but it is not currently able to serve as an initial noninvasive diagnostic tool for trauma patients. There was poor correlation between clinical Hgb and SpHb, and because of that, SpHb should not be used to evaluate hemoglobin levels in trauma patients.

Impact of Social Media on Community Consultation in Exception From Informed Consent Clinical Trials.

BACKGROUND: Exception from informed consent (EFIC) allows clinician scientists to perform much needed emergency research. Obtaining this exception, however, requires many meetings with community groups for consultation, which can make the process time-consuming and expensive. We aim to determine the impact of using social media in lieu of some community meetings in an effort to obtain an EFIC. MATERIALS AND METHODS: An economic analysis of four randomized clinical trials was performed. Costs were conservatively estimated using personnel costs, social media costs, and adjusted to 2016 US dollars. People were considered reached if they attended a community meeting or were directed to the study website by social media and spent ≥1 min. RESULTS: The Early Whole Blood study required 14 meetings, reached 272 people, and cost $8260 ($30/person reached). The Pragmatic, Randomized Optimal Platelet and Plasma Ratios study required 14 meetings, reached 260 people, and cost $7479 overall ($29/person reached). The Prehospital Tranexamic Acid Use for Traumatic Brain Injury study required 12 meetings, reached 198 people, and cost $6340 ($32/person reached). Only the damage control laparotomy trial utilized social media in lieu of some community meetings. The damage control laparotomy trial required six meetings at which 137 people were reached. The $1000 social media campaign reached 229 people. The cost was $3977 overall and $11/person reached. CONCLUSIONS: Including a social media campaign during the EFIC process increased the number of potential patients reached and reduced total and per person costs reached costs. Obtaining an EFIC for future emergency clinical trials may be facilitated by the inclusion of a social media campaign.

Making thawed universal donor plasma available rapidly for massively bleeding trauma patients: experience from the Pragmatic, Randomized Optimal Platelets and Plasma Ratios (PROPPR) trial.

BACKGROUND: The Pragmatic, Randomized Optimal Platelets and Plasma Ratios (PROPPR) trial was a randomized clinical trial comparing survival after transfusion of two different blood component ratios for emergency resuscitation of traumatic massive hemorrhage. Transfusion services supporting the study were expected to provide thawed plasma, platelets, and red blood cells within 10 minutes of request. STUDY DESIGN AND METHODS: At the 12 Level 1 trauma centers participating in PROPPR, blood components transfused and delivery times were tabulated, with a focus on universal donor (UD) plasma management. The adequacy of site plans was assessed by comparing the bedside blood availability times to study goals and the new American College of Surgeons guidelines. RESULTS: Eleven of 12 sites were able to consistently deliver 6 units of thawed UD plasma to their trauma-receiving unit within 10 minutes and 12 units in 20 minutes. Three sites used blood group A plasma instead of AB for massive transfusion without complications. Approximately 4700 units of plasma were given to the 680 patients enrolled in the trial. No site experienced shortages of AB plasma that limited enrollment. Two of 12 sites reported wastage of thawed AB plasma approaching 25% of AB plasma prepared. CONCLUSION: Delivering UD plasma to massively hemorrhaging patients was accomplished consistently and rapidly and without excessive wastage in high-volume trauma centers. The American College of Surgeons Trauma Quality Improvement Program guidelines for massive transfusion protocol UD plasma availability are practicable in large academic trauma centers. Use of group A plasma in trauma resuscitation needs further study.

Prehospital Transfusion of Plasma and Red Blood Cells in Trauma Patients.

Abstract Objective. Earlier use of plasma and red blood cells (RBCs) has been associated with improved survival in trauma patients with substantial hemorrhage. We hypothesized that prehospital transfusion (PHT) of thawed plasma and/or RBCs would result in improved patient coagulation status on admission and survival. Methods. Adult trauma patient records were reviewed for patient demographics, shock, coagulopathy, outcomes, and blood product utilization from September 2011 to April 2013. Patients arrived by either ground or two different helicopter companies. All patients transfused with blood products (either pre- or in-hospital) were included in the study. One helicopter system (LifeFlight, LF) had thawed plasma and RBCs while the other air (OA) and ground transport systems used only crystalloid resuscitation. Patients receiving PHT were compared with all other patients meeting entry criteria to the study cohort. All comparisons were adjusted in multilevel regression models. Results. A total of 8,536 adult trauma patients were admitted during the 20-month study period, of which 1,677 met inclusion criteria. They represented the most severely injured patients (ISS = 24 and mortality = 26%). There were 792 patients transported by ground, 716 by LF, and 169 on OA. Of the LF patients, 137 (19%) received prehospital transfusion. There were 942 units (244 RBCs and 698 plasma) placed on LF helicopters, with 1.9% wastage. PHT was associated with improved acid-base status on hospital admission, decreased use of blood products over 24 hours, a reduction in the risk of death in the sickest patients over the first 6 hours after admission, and negligible blood products wastage. In this small single-center pilot study, there were no differences in 24-hour (odds ratio 0.57, p = 0.117) or 30-day mortality (odds ratio 0.71, p = 0.441) between LF and OA. Conclusions. Prehospital plasma and RBC transfusion was associated with improved early outcomes, negligible blood products wastage, but not an overall survival advantage. Similar to the data published from the ongoing war, improved early outcomes are associated with placing blood products prehospital, allowing earlier infusion of life-saving products to critically injured patients.

Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial.

IMPORTANCE: Severely injured patients experiencing hemorrhagic shock often require massive transfusion. Earlier transfusion with higher blood product ratios (plasma, platelets, and red blood cells), defined as damage control resuscitation, has been associated with improved outcomes; however, there have been no large multicenter clinical trials. OBJECTIVE: To determine the effectiveness and safety of transfusing patients with severe trauma and major bleeding using plasma, platelets, and red blood cells in a 1:1:1 ratio compared with a 1:1:2 ratio. DESIGN, SETTING, AND PARTICIPANTS: Pragmatic, phase 3, multisite, randomized clinical trial of 680 severely injured patients who arrived at 1 of 12 level I trauma centers in North America directly from the scene and were predicted to require massive transfusion between August 2012 and December 2013. INTERVENTIONS: Blood product ratios of 1:1:1 (338 patients) vs 1:1:2 (342 patients) during active resuscitation in addition to all local standard-of-care interventions (uncontrolled). MAIN OUTCOMES AND MEASURES: Primary outcomes were 24-hour and 30-day all-cause mortality. Prespecified ancillary outcomes included time to hemostasis, blood product volumes transfused, complications, incidence of surgical procedures, and functional status. RESULTS: No significant differences were detected in mortality at 24 hours (12.7% in 1:1:1 group vs 17.0% in 1:1:2 group; difference, -4.2% [95% CI, -9.6% to 1.1%]; P = .12) or at 30 days (22.4% vs 26.1%, respectively; difference, -3.7% [95% CI, -10.2% to 2.7%]; P = .26). Exsanguination, which was the predominant cause of death within the first 24 hours, was significantly decreased in the 1:1:1 group (9.2% vs 14.6% in 1:1:2 group; difference, -5.4% [95% CI, -10.4% to -0.5%]; P = .03). More patients in the 1:1:1 group achieved hemostasis than in the 1:1:2 group (86% vs 78%, respectively; P = .006). Despite the 1:1:1 group receiving more plasma (median of 7 U vs 5 U, P < .001) and platelets (12 U vs 6 U, P < .001) and similar amounts of red blood cells (9 U) over the first 24 hours, no differences between the 2 groups were found for the 23 prespecified complications, including acute respiratory distress syndrome, multiple organ failure, venous thromboembolism, sepsis, and transfusion-related complications. CONCLUSIONS AND RELEVANCE: Among patients with severe trauma and major bleeding, early administration of plasma, platelets, and red blood cells in a 1:1:1 ratio compared with a 1:1:2 ratio did not result in significant differences in mortality at 24 hours or at 30 days. However, more patients in the 1:1:1 group achieved hemostasis and fewer experienced death due to exsanguination by 24 hours. Even though there was an increased use of plasma and platelets transfused in the 1:1:1 group, no other safety differences were identified between the 2 groups. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01545232.

A randomized controlled pilot trial of modified whole blood versus component therapy in severely injured patients requiring large volume transfusions.

OBJECTIVES: To determine whether resuscitation of severely injured patients with modified whole blood (mWB) resulted in fewer overall transfusions compared with component (COMP) therapy. BACKGROUND: For decades, whole blood (WB) was the primary product for resuscitating patients in hemorrhagic shock. After dramatic advances in blood banking in the 1970s, blood donor centers began supplying hospitals with individual components [red blood cell (RBC), plasma, platelets] and removed WB as an available product. However, no studies of efficacy or hemostatic potential in trauma patients were performed before doing so. METHODS: Single-center, randomized trial of severely injured patients predicted to large transfusion volume. Pregnant patients, prisoners, those younger than 18 years or with more than 20% total body surface area burns (TBSA) burns were excluded. Patients were randomized to mWB (1 U mWB) or COMP therapy (1 U RBC+ 1 U plasma) immediately on arrival. Each group also received 1 U platelets (apheresis or prepooled random donor) for every 6 U of mWB or 6 U of RBC + 6 U plasma. The study was performed under the Exception From Informed Consent (Food and Drug Administration 21 code of federal regulations [CFR] 50.24). Primary outcome was 24-hour transfusion volumes. RESULTS: A total of 107 patients were randomized (55 mWB, 52 COMP therapy) over 14 months. There were no differences in demographics, arrival vitals or laboratory values, injury severity, or mechanism. Transfusions were similar between groups (intent-to-treat analysis). However, when excluding patients with severe brain injury (sensitivity analysis), WB group received less 24-hour RBC (median 3 vs 6, P = 0.02), plasma (4 vs 6, P = 0.02), platelets (0 vs 3, P = 0.09), and total products (11 vs 16, P = 0.02). CONCLUSIONS: Compared with COMP therapy, WB did not reduce transfusion volumes in severely injured patients predicted to receive massive transfusion. However, in the sensitivity analysis (patients without severe brain injuries), use of mWB significantly reduced transfusion volumes, achieving the prespecified endpoint of this initial pilot study.

Resuscitative endovascular balloon occlusion of the aorta (REBOA) may be superior to resuscitative thoracotomy (RT) in patients with traumatic brain injury (TBI).

Background: The effects of aortic occlusion (AO) on brain injury are not well defined. We examined the impact of AO by resuscitative endovascular balloon occlusion of the aorta (REBOA) and resuscitative thoracotomy (RT) on outcomes in the setting of traumatic brain injury (TBI). Methods: Patients sustaining TBI who underwent RT or REBOA in zone 1 (thoracic aorta) from September 2013 to December 2018 were identified. The indication for REBOA or RT was hemodynamic collapse due to hemorrhage below the diaphragm. Primary outcomes included mortality and systemic complications. Results: 282 patients underwent REBOA or RT. Of these, 76 had mild TBI (40 REBOA, 36 RT) and 206 sustained severe TBI (107 REBOA, 99 RT). Overall, the mean (±SD) age was 42±17 years, with an Injury Severity Score (ISS) of 40±17 and mean systolic blood pressure (SBP) at the time of REBOA or RT of 81±34 mm Hg. REBOA patients had a mean SBP at the time of AO of 78.39±29.45 mm Hg, whereas RT patients had a mean SBP of 83.18±37.87 mm Hg at the time of AO (p=0.24). 55% had ongoing cardiopulmonary resuscitation (CPR) at the time of AO, and the in-hospital mortality was 86%. Binomial logistic regression controlling for TBI severity, age, ISS, SBP at the time of AO, crystalloid infusion, and CPR during AO demonstrated that the odds of mortality are 3.1 times higher for RT compared with REBOA. No significant differences were found in systemic complications between RT and REBOA. Discussion: Patients with TBI who receive REBOA may have improved survival, but no difference in systemic complications, compared with patients who receive RT for the same indication. Although some patients are receiving RT prior to arrest for extrathoracic hemorrhagic shock, these results suggest that REBOA should be considered as an alternative to RT when RT is chosen for the sole purpose of resuscitation in the setting of TBI. Level of evidence: 4.

Survival benefit for pelvic trauma patients undergoing Resuscitative Endovascular Balloon Occlusion of the Aorta: Results of the AAST Aortic Occlusion for Resuscitation in Trauma Acute Care Surgery (AORTA) Registry.

BACKGROUND: Aortic occlusion (AO) to facilitate the acute resuscitation of trauma and acute care surgery patients in shock remains a controversial topic. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) is an increasingly deployed method of AO. We hypothesized that in patients with non-compressible hemorrhage below the aortic bifurcation, the use of REBOA instead of open AO may be associated with a survival benefit. METHODS: From the AAST Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery (AORTA) registry, we identified 1494 patients requiring AO from 45 Level I and 4 Level II trauma centers. Presentation, intervention, and outcome variables were analyzed to compare REBOA vs open AO in patients with non-compressible hemorrhage below the aortic bifurcation. RESULTS: From December 2014 to January 2019, 217 patients with Zone 3 REBOA or Open AO who required pelvic packing, pelvic fixation or pelvic angio-embolization were identified. Of these, 109 AO patients had injuries isolated to below the aortic bifurcation (REBOA, 84; open AO, 25). Patients with intra-abdominal or thoracic sources of bleeding, above deployment Zone 3 were excluded. Overall mortality was lower in the REBOA group (35.% vs 80%, p <.001). Excluding patients who arrived with CPR in progress, the REBOA group had lower mortality (33.33% vs. 68.75%, p = 0.012). Of the survivors, systemic complications were not significantly different between groups. In the REBOA group, 16 patients had complications secondary to vascular access. Intensive care lengths of stay and ventilator days were both significantly shorter in REBOA patients who survived to discharge. CONCLUSIONS: This study compared outcomes for patients with hemorrhage below the aortic bifurcation treated with REBOA to those treated with open AO. Survival was significantly higher in REBOA patients compared to open AO patients, while complications in survivors were not different. Given the higher survival in REBOA patients, we conclude that REBOA should be used for patients with hemorrhagic shock secondary to pelvic trauma instead of open AO. LEVEL III EVIDENCE: Therapeutic.

Life over limb: Arterial access-related limb ischemic complications in 48-hour REBOA survivors.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is increasingly used in some trauma settings. Arterial access-related limb ischemic complications (ARLICs) resulting from the femoral arterial access required for REBOA are largely under reported. We sought to describe the incidence of these complications and the clinical, technical, and device factors associated with their development. METHODS: This was a retrospective cohort study of records of adult trauma patients from the American Association for the Surgery of Trauma Aortic Occlusion for Resuscitation in Trauma and Acute care surgery registry between October 2013 and September 2020 who had REBOA and survived at least 48 hours. The primary outcome was ARLIC, defined as clinically relevant extremity ischemia or distal embolization. Relevant factors associated with ARLIC were also analyzed. RESULTS: Of 418 identified patients, 36 (8.6%) sustained at least one ARLIC; 22 with extremity ischemia, 25 with distal embolism, 11 with both. Patient demographics and injury characteristics were similar between ARLIC and no ARLIC groups. Access-related limb ischemic complication was associated with larger profile devices (p = 0.009), cutdown access technique (p = 0.02), and the presence of a pelvic external fixator/binder (p = 0.01). Patients with ARLIC had higher base deficit (p = 0.03) and lactate (p = 0.006). One hundred fifty-six patients received tranexamic acid (TXA), with 22 (14%) ARLICs. The rate of TXA use among ARLIC patients was 61% (vs. 35% TXA for non-ARLIC patients, p = 0.002). Access-related limb ischemic complication did not result in additional in-hospital mortality, however, ARLIC had prolonged hospital LOS (31 vs. 24 days, p = 0.02). Five ARLIC required surgical intervention, three patch angioplasty (and two with associated bypass), and four ARLIC limbs were amputated. CONCLUSION: Femoral artery REBOA access carries a risk of ARLIC, which is associated with unstable pelvis fractures, severe shock, and strongly with the administration of TXA. Use of lower-profile devices and close surveillance for these complications is warranted in these settings and caution should be exercised when using TXA in conjunction with REBOA. LEVEL OF EVIDENCE: Prognostic and Epidemiologic, Level III.

Traumatic Brain Injury in Older Adults: Characteristics, Outcomes, and Considerations. Results From the American Association for the Surgery of Trauma Geriatric Traumatic Brain Injury (GERI-TBI) Multicenter Trial.

OBJECTIVES: Describe the epidemiology of a large cohort of older adults with isolated traumatic brain injury (TBI) and identify predictors of mortality, palliative interventions, and discharge to preinjury residence in those presenting with moderate/severe TBI. DESIGN: Prospective observational study of geriatric patients with TBI enrolled across 45 trauma centers. SETTING AND PARTICIPANTS: Inclusion criteria were age ≥40 years, and computed tomography (CT)-verified TBI. Exclusion criteria were any other body region abbreviated injury scale score >2 and presentation at enrolling center >24 hours after injury. METHODS: The analysis was restricted to individuals aged ≥65 and stratified into 3 age groups: young-old (65-74), middle-old (75-84), and oldest-old (≥85). Demographic, clinical, and injury data were collected. Predictors of mortality, palliative interventions, and discharge to preinjury residence in the moderate/severe TBI group were identified using Classification and Regression Tree and Generalized Linear Mixed Models. RESULTS: Of the 3081 subjects enrolled in the study, 2028 were ≥65 years old. Overall, 339 (16.7%) presented with a moderate/severe TBI and experienced a 64% mortality rate. A Glasgow Coma Scale (GCS) score <9 was the main predictor of mortality, CT worsening (odds ratio [OR] = 1.7, P < .04), cerebral edema (OR = 2.4, P < .04), GCS <9, and age ≥75 (OR = 2.1, P = .007) were predictors for palliative interventions, and an injury severity score ≤24 (OR = 0.087, P = .002) was associated with increased likelihood of discharge to preinjury residence in the moderate/severe TBI group. CONCLUSION AND IMPLICATIONS: In this prospective study of a large cohort of older adults with isolated TBI, comparisons across the older age groups with moderate/severe TBI revealed that survival and favorable discharge disposition were influenced more by severity of injury rather than age itself. Indicating that chronological age alone maybe insufficient to accurately predict outcomes, and increased representation of older adults in TBI research to develop better diagnostic and prognostic tools is warranted.

Association of Changes in Antithrombin Activity Over Time With Responsiveness to Enoxaparin Prophylaxis and Risk of Trauma-Related Venous Thromboembolism.

Importance: Venous thromboembolism (VTE) affects 2% to 20% of recovering trauma patients, despite aggressive prophylaxis with enoxaparin. Antithrombin is a primary circulating anticoagulant and crucial component of enoxaparin thromboprophylaxis. Approximately 20% of trauma patients present with antithrombin deficiency (antithrombin activity <80%). Objective: To examine time-dependent changes in antithrombin activity, responsiveness to enoxaparin, as measured by anti-factor Xa (anti-FXa) levels, and incidence of VTE after severe trauma and to assess the association of ex vivo antithrombin supplementation with patients' sensitivity to enoxaparin prophylaxis. Design, Setting, and Participants: This single-center, prospective cohort study was performed at a level 1 trauma center between January 7, 2019, and February 28, 2020. Adult trauma patients admitted to the trauma service at high risk for VTE, based on injury pattern and severity, were screened and enrolled. Patients who were older than 70 years, were pregnant, had a known immunologic or coagulation disorder, or were receiving prehospital anticoagulants were excluded. Exposures: Blood samples were collected on emergency department arrival and daily for the first 8 days of hospitalization. Main Outcomes and Measures: Patients' antithrombin activity and anti-FXa levels were measured by a coagulation analyzer, and thrombin generation was measured by calibrated automated thrombography. Responsiveness to enoxaparin was assessed by measuring anti-FXa levels 4 to 6 hours after the first daily enoxaparin dose and compared between patients who developed VTE and who did not. In addition, the associations of ex vivo supplementation of antithrombin with plasma anti-FXa levels were assessed. Results: Among 150 patients enrolled (median [IQR] age, 35 [27-53] years; 37 [24.7%] female and 113 [75.3%] male; 5 [3.3%] Asian, 32 [21.3%] Black, and 113 [75.3%] White; and 51 [34.0%] of Hispanic ethnicity), 28 (18.7%) developed VTE. Patients with VTE had significantly lower antithrombin activity on admission compared with patients without VTE (median [IQR], 91% [79%-104%] vs 100% [88%-112%]; P = .04), as well as lower antithrombin activity on hospital days 5 (median (IQR), 90% [83%-99%] vs 114% [99%-130%]; P = .011), 6 (median [IQR], 97% [81%-109%] vs 123% [104%-134%]; P = .003), 7 (median [IQR], 82% [74%-89%] vs 123% [110%-140%]; P < .001), and 8 (median [IQR], 99% [85%-100%] vs 123% [109%-146%]; P = .011). Anti-FXa levels were significantly lower in patients with VTE vs those without VTE at hospital day 4 (median [IQR], 0.10 [0.05-0.14] IU/mL vs 0.18 [0.13-0.23] IU/mL; P = .006), day 6 (median [IQR], 0.12 [0.08-0.14] IU/mL vs 0.22 [0.13-0.28] IU/mL; P = .02), and day 7 (median [IQR], 0.11 [0.08-0.12] IU/mL vs 0.21 [0.13, 0.28] IU/mL; P = .002). Multivariable analyses found that for every 10% decrease in antithrombin activity during the first 3 days, the risk of VTE increased 1.5-fold. Conclusions and Relevance: The results of this cohort study suggest that after severe trauma, antithrombin deficiency is common and contributes to enoxaparin resistance and VTE. Interventional studies are necessary to determine the efficacy of antithrombin supplementation in the reduction of VTE incidence.

Current use of damage-control laparotomy, closure rates, and predictors of early fascial closure at the first take-back.

BACKGROUND: Damage-control laparotomy (DCL) is a lifesaving technique but carries significant morbidity. If DCL is over used and the factors that predict early fascial closure have not been fully evaluated. The purpose of the current study was to determine (1) the current rate of DCL, (2) the percentage of DCLs that are closed at first take-back, and (3) possible physiologic and resuscitative parameters predicting early fascial closure. METHODS: A retrospective review of all trauma laparotomies from a Level I trauma center between January 2004 and December 2008 was performed. Patients were excluded if they died before first take-back. Univariate and multivariate analyses were performed. RESULTS: Nine hundred thirty patients were eligible, 278 (30%) underwent DCL, 36 excluded for death before first take-back. Of the remaining 242 DCL patients, 83 (34%) were closed at first take-back and 159 (66%) were not closed at first take-back. These two groups were similar in injury severity, demographics, and prehospital and emergency department fluids and vitals. Median emergency department international normalized ratio (INR; 1.13 vs. 1.29, p = 0.010), post-op INR (1.4 vs. 1.5, p = 0.028), 24-hour fluids (11.9 L vs. 15.5 L, p = 0.006), peak post-op intra-abdominal pressure (IAP; 15 vs. 18, p < 0.001), and mortality (1.2% vs. 8.2%, p = 0.027) were different between groups. Multivariate analysis noted vacuum-assisted closure at initial laparotomy (Odds ratio, 3.1; 95% confidence interval [CI], 1.42-6.63; p = 0.004) was an independent predictor of closure at first take-back. However, post-op INR (Odds ratio, 0.18; 95% CI, 0.03-0.97; p = 0.04) and post-op peak IAP (Odds ratio, 0.85; 95% CI, 0.76-0.95; p = 0.005) predicted failure to close fascia at first take-back. CONCLUSION: In similarly injured DCL patients, increased post-op INR and IAP predicted inability to achieve primary fascial closure on first take-back, while use of the vacuum-assisted closure was associated with increased likelihood of early fascial closure. At a busy academic Level I trauma center, the current rate of DCL among those undergoing emergent laparotomy is 30%. Whether this represents optimal use or overutilization of this technique still needs to be determined.

Rapid thrombelastography delivers real-time results that predict transfusion within 1 hour of admission.

BACKGROUND: Recognition of trauma-induced coagulopathy by conventional coagulation testing (CCT) is limited by their slow results, incomplete characterization, and their poor predictive nature. Rapid thrombelastography (r-TEG) delivers a more comprehensive assessment of the coagulation system but has not been prospectively validated in trauma patients. The purpose of this pilot study was to evaluate the timeliness of r-TEG results, their correlation with CCTs, and the ability of r-TEG to predict early blood transfusion. METHODS: Over a 5-month period, 583 consecutive major trauma activations were prospectively entered into a database, of which 272 met entry criteria. r-TEG and CCTs (prothrombin time, international normalized ratio, partial thromboplastin time, and platelet count) were obtained on all patients. Graphical results for r-TEG were displayed "real time" in the trauma bay. Spearman's correlation and regression models were used to compare r-TEG and CCTs. RESULTS: Early r-TEG values (activated clotting time [ACT], k-time, and r-value) were available within 5 minutes, late r-TEG values (maximal amplitude and α-angle) within 15 minutes, and CCTs within 48 minutes (p < 0.001). ACT, r-value, and k-time showed strong correlation with prothrombin time, international normalized ratio, and partial thromboplastin time (all r >0.70; p < 0.001), whereas maximal amplitude (r = -0.49) and α-angle (r = 0.40) correlated with platelet count (both p < 0.001). Linear regression demonstrated ACT predicted red blood cells (coef. 0.05; 95% confidence interval [CI], 0.04-0.06; p < 0.001), plasma (coef. 0.03; 95% CI, 0.02-0.04; p < 0.001), and platelet (coef. 0.06; 95% CI, 0.04-0.07; p < 0.001) transfusions within the first 2 hours of arrival. Controlling for all demographics and Emergency Department vitals, ACT >128 predicted massive transfusion (≥10 U) in the first 6 hours (odds ratio, 5.15; 95% CI, 1.36-19.49; p = 0.01). In addition, ACT <105 predicted patients who did not receive any transfusions in the first 24 hours (odds ratio, 2.80; CI, 1.02-7.07; p = 0.04). CONCLUSIONS: Graphical r-TEG results are available within minutes, correlate with conventional coagulation test that are not as rapidly available, and are predictive of early transfusions of packed red blood cells, plasma, and platelets.

Impact of closure at the first take back: complication burden and potential overutilization of damage control laparotomy.

BACKGROUND: Damage control laparotomy (DCL) is a lifesaving technique initially employed to minimize the lethal triad of coagulopathy, hypothermia, and acidosis. Recently, it has been recognized that DCL itself carries significant morbidity and may be overutilized. The purpose of this study was to determine (1) whether early fascial closure is associated with a reduction in postoperative complications and (2) whether patients at our institution met traditional DCL indications (acidosis, hypothermia, and coagulopathy). METHODS: This is a retrospective review of all patients undergoing immediate laparotomy at a Level I trauma center between 2004 and 2008. DCL was defined as temporary abdominal closure at the initial surgery. Early closure was defined as primary fascial closure at initial take back laparotomy. Patients were excluded if they died before first take back. Acidosis (pH <7.30), hypothermia (temperature <95.0°F), and coagulopathy (international normalized ratio >1.5) were measured on intensive care unit (ICU) arrival. RESULTS: Totally, 925 patients were eligible. Thirty percent had DCL employed. Of these, 86 subjects (34%) were closed at first take back while 161 (66%) were not. Both groups were similar in demographics, injury severity score, resuscitation volumes, blood products, and prehospital, emergency department, and operating room vital signs. Univariate analyses noted that intra-abdominal abscesses (8.4% vs. 21.3%), respiratory failure (14.4% vs. 37.1%), sepsis (8.4% vs. 25.1%), and renal failure (3.6% vs. 25.1%) were lower in patients closed at first take back (all <0.05). Controlling for age, gender, injury severity score, and transfusions, logistic regression analysis noted that closure at the first take back was associated with a reduction in infectious (odds ratio, 0.28; 95% confidence interval [CI], 0.12-0.66; p = 0.004) and noninfectious abdominal complications (odds ratio, 0.23; 95% CI, 0.09-0.56; p = 0.001) as well as wound (odds ratio, 0.31; 95% CI, 0.13-0.72; p = 0.007) and pulmonary complications (odds ratio, 0.35; CI, 0.20-0.62; p < 0.001). Of patients closed at the initial take back, 78% were acidotic (35%), coagulopathic (49%), or hypothermic (44%) on initial ICU admission. CONCLUSION: Early fascial closure is an independent predictor of reduced complications in DCL patients. One in five patients closed at initial take back did not meet any of the traditional indications for DCL upon initial ICU admission. This may represent an overutilization of this valuable technique, exposing patients to increased complications. Further efforts should be directed at achieving both early facial closure as well as redefining the appropriate indications for DCL.

Hard signs gone soft: A critical evaluation of presenting signs of extremity vascular injury.

BACKGROUND: Despite advances in management of extremity vascular injuries, "hard signs" remain the primary criterion to determine need for imaging and urgency of exploration. We propose that hard signs are outdated and that hemorrhagic and ischemic signs of vascular injury may be of greater clinical utility. METHODS: Extremity arterial injuries from the American Association for the Surgery of Trauma PROspective Observational Vascular Injury Treatment registry were analyzed to examine the relationships between hard signs, ischemic signs, and hemorrhagic signs of extremity vascular injury with workup, diagnosis, and management. RESULTS: Of 1,910 cases, 1,108 (58%) had hard signs of vascular injury. Computed tomography angiography (CTA) was more commonly used as the diagnostic modality in patients without hard signs, while operative exploration was primarily used for diagnosis in hard signs. Patients undergoing CTA were more likely to undergo endovascular or hybrid repair (EHR) (10.7%) compared with patients who underwent exploration for diagnosis (1.5%). Of 915 patients presenting with hemorrhagic signs, CTA was performed 14.5% of the time and was associated with a higher rate of EHR and observation. Of the 490 patients presenting with ischemic signs, CTA was performed 31.6% of the time and was associated with higher rates of EHR and observation. Hemorrhagic signs were associated with arterial transection, while ischemic signs were associated with arterial occlusion. Patients with ischemic signs undergoing exploration for diagnosis received more units of packed red blood cells during the first 24 hours. There was no difference in amputation rate, reintervention rate, hospital length of stay, or mortality in comparing groups who underwent CTA versus exploration. CONCLUSION: Hard signs have limitations in identification and characterization of extremity arterial injuries. A strategy of using hemorrhagic and ischemic signs of vascular injury is of greater clinical utility. Further prospective study is needed to validate this proposed redefinition of categorization of presentations of extremity arterial injury. LEVEL OF EVIDENCE: Diagnostic, level III.

Temporal Changes in REBOA Utilization Practices are Associated With Increased Survival: an Analysis of the AORTA Registry.

BACKGROUND: Aortic occlusion (AO) is utilized for patients in extremis, with resuscitative endovascular balloon occlusion of the aorta (REBOA) use increasing. Our objective was to examine changes in AO practices and outcomes over time. The primary outcome was the temporal variation in AO mortality, while secondary outcomes included changes in technique, utilization, and complications. STUDY DESIGN: This study examined the AORTA registry over a 5-year period (2014-2018). AO outcomes and utilization were analyzed using year of procedure as an independent variable. A multivariable model adjusting for year of procedure, signs of life (SOL), SBP at AO initiation, operator level, timing of AO, and hemodynamic response to AO was created to analyze AO mortality. RESULTS: One thousand four hundred fifty-eight AO were included. Mean age (39.1 ±â€Š16.7) and median ISS (34[25,49]) were comparable between REBOA and open AO. Open AO patients were more likely: male (84% vs. 77%, P = 0.001), s/p penetrating trauma (61% vs. 19%, P < 0.001), and arrived without SOL (60% vs. 40%, P = 0.001). REBOA use increased significantly and adjusted mortality decreased 22%/year while open AO survival was unchanged. REBOA initiation SBP increased significantly over the study period (52.2 vs. 65, P = 0.04). Compared with patients undergoing AO with CPR, each decile increase in SBP improved survival 12% (AOR 1.12, adj P = 0.001). The use of 7F REBOA (2.9%-54.8%) and Zone III deployment increased significantly (14.7% vs 40.6%), with Zone III placement having decreased associated mortality (AOR 0.33, adj P = 0.001). Overall REBOA complication rate was 4.5% and did not increase over time (P = 0.575). CONCLUSIONS: REBOA survival has increased significantly while open AO survival remained unchanged. This may be related to lower thresholds for REBOA insertion at higher blood pressures, increased operator experience, and improved catheter technology leading to earlier deployment.

Factors associated with receipt of intracranial pressure monitoring in older adults with traumatic brain injury.

BACKGROUND: The Brain Trauma Foundation (BTF) Guidelines for the Management of Severe Traumatic Brain Injury (TBI) include intracranial pressure monitoring (ICPM), yet very little is known about ICPM in older adults. Our objectives were to characterize the utilization of ICPM in older adults and identify factors associated with ICPM in those who met the BTF guidelines. METHODS: We analyzed data from the American Association for the Surgery of Trauma Geriatric TBI Study, a registry study conducted among individuals with isolated, CT-confirmed TBI across 45 trauma centers. The analysis was restricted to those aged ≥60. Independent factors associated with ICPM for those who did and did not meet the BTF guidelines were identified using logistic regression. RESULTS: Our sample was composed of 2303 patients, of whom 66 (2.9%) underwent ICPM. Relative to Glasgow Coma Scale (GCS) score of 13 to 15, GCS score of 9 to 12 (OR 10.2; 95% CI 4.3 to 24.4) and GCS score of <9 (OR 15.0; 95% CI 7.2 to 31.1), intraventricular hemorrhage (OR 2.4; 95% CI 1.2 to 4.83), skull fractures (OR 3.6; 95% CI 2.0 to 6.6), CT worsening (OR 3.3; 95% CI 1.8 to 5.9), and neurosurgical interventions (OR 3.8; 95% CI 2.1 to 7.0) were significantly associated with ICPM. Restricting to those who met the BTF guidelines, only 43 of 240 (18%) underwent ICPM. Factors independently associated with ICPM included intraparenchymal hemorrhage (OR 2.2; 95% CI 1.0 to 4.7), skull fractures (OR 3.9; 95% CI 1.9 to 8.2), and neurosurgical interventions (OR 3.5; 95% CI 1.7 to 7.2). DISCUSSION: Worsening GCS, intraparenchymal/intraventricular hemorrhage, and skull fractures were associated with ICPM among older adults with TBI, yet utilization of ICPM remains low, especially among those meeting the BTF guidelines, and potential benefits remain unclear. This study highlights the need for better understanding of factors that influence compliance with BTF guidelines and the risks versus benefits of ICPM in this population. LEVEL OF EVIDENCE: Prognostic and epidemiological, level III.