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.

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.

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.

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.

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.

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.

Variation in time to notification of enrollment and rates of withdrawal in resuscitation trials conducted under exception from informed consent.

IMPORTANCE: Emergency research is challenging to do well as it involves time sensitive interventions in unstable patients. There is limited time to obtain informed consent from the patient or their legally authorized representative (LAR). Such research is permitted under exception from informed consent (EFIC) if specific criteria are met, including notification after enrollment. Some question whether the risks of EFIC outweighs its benefits. To date, there is limited empiric information about time to notification (TTN) and rates of withdrawal in such trials. OBJECTIVE: To describe variation in TTN and rates of withdrawal among that patients enrolled in EFIC trials over a twelve-year period. DESIGN: We performed post hoc descriptive analyses of data from five trials conducted under EFIC. SETTING: Emergency medical services and receiving hospitals participating in the Resuscitation Outcomes Consortium in the United States and Canada. PARTICIPANTS: Patients with out-of-hospital cardiac arrest or life-threatening traumatic injury. EXPOSURES: Notification strategies were specified at each site before initiation of enrollment by a local institutional review board. We monitored TTN within each site centrally throughout each study's enrollment period. OUTCOMES: TTN was defined as time from randomization to first-reported notification of patient or LAR of enrollment. Withdrawal was defined as patient or LAR opt out of ongoing participation at the time of notification. RESULTS: Of 35,442 patients enrolled in five trials, 33,805 had cardiac arrest; and 1636 had traumatic injury. TTN varied overall and by patient outcome. Among those with cardiac arrest, TTN ranged from median (5%ile, 95%ile) of 6 (1,27) days to 28 (2, 53) days across sites. 0.3% of notified patients with cardiac arrest withdrew. Among those with traumatic injury, TTN ranged from 0 (0, 5) days to 36 (5, 68) days across sites. 7.7% of notified patients with traumatic injury withdrew. CONCLUSIONS AND RELEVANCE: There is large variation in TTN in trials conducted under EFIC for emergency research. This may be due to several factors. It may or may not be modifiable. Overall rates of withdrawal are low, which suggests current practices related to EFIC are acceptable to those who have participated in emergency research.

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.

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.

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.

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.

Intraoperative REBOA: an analysis of the American Association for the Surgery of Trauma AORTA registry.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a less-invasive technique for aortic occlusion (AO). Commonly performed in the emergency department (ED), the role of intraoperative placement is less defined. We hypothesized that operating room (OR) placement is associated with increased in-hospital mortality. METHODS: The American Association for the Surgery of Trauma AORTA registry was used to identify patients undergoing REBOA. Injury characteristics and outcomes data were compared between OR and ED groups. The primary outcome was in-hospital mortality; secondary outcomes included total AO time, transfusion requirements, and acute kidney injury. RESULTS: Location and timing of catheter insertion were available for 305 of 321 (95%) subjects. 58 patients underwent REBOA in the OR (19%). There were no differences with respect to sex, admission lactate, and Injury Severity Score. The OR group was younger (33 years vs. 41 years, p=0.01) and with more penetrating injuries (36% vs. 15%, p<0.001). There were significant differences with respect to admission physiology. Time from admission to AO was longer in the OR group (75 minutes vs. 23 minutes, p<0.001) as was time to definitive hemostasis (116 minutes vs. 79 minutes, p=0.01). Unadjusted mortality was lower in the OR group (36.2% vs. 68.8%, p<0.001). There were no differences in secondary outcomes. After controlling for covariates, there was no association between insertion location and in-hospital mortality (OR 1.8, 95% CI 0.30 to 11.50). DISCUSSION: OR REBOA placement is common and generally employed in patients with more stable admission physiology. OR placement was not associated with increased in-hospital mortality despite longer times to AO and definite hemostasis when compared with catheters placed in the ED. LEVEL OF EVIDENCE: IV; therapeutic/care management.

Earlier time to hemostasis is associated with decreased mortality and rate of complications: Results from the Pragmatic Randomized Optimal Platelet and Plasma Ratio trial.

BACKDROP: Clinicians intuitively recognize that faster time to hemostasis is important in bleeding trauma patients, but these times are rarely reported. METHODS: Prospectively collected data from the Pragmatic Randomized Optimal Platelet and Plasma Ratios trial were analyzed. Hemostasis was predefined as no intraoperative bleeding requiring intervention in the surgical field or resolution of contrast blush on interventional radiology (IR). Patients who underwent an emergent (within 90 minutes) operating room (OR) or IR procedure were included. Mixed-effects Poisson regression with robust error variance (controlling for age, Injury Severity Score, treatment arm, injury mechanism, base excess on admission [missing values estimated by multiple imputation], and time to OR/IR as fixed effects and study site as a random effect) with modified Bonferroni corrections tested the hypothesis that decreased time to hemostasis was associated with decreased mortality and decreased incidence of acute kidney injury (AKI), acute respiratory distress syndrome (ARDS), multiple-organ failure (MOF), sepsis, and venous thromboembolism. RESULTS: Of 680 enrolled patients, 468 (69%) underwent an emergent procedure. Patients with decreased time to hemostasis were less severely injured, had less deranged base excess on admission, and lower incidence of blunt trauma (all p < 0.05). In 408 (87%) patients in whom hemostasis was achieved, every 15-minute decrease in time to hemostasis was associated with decreased 30-day mortality (RR, 0.97; 95% confidence interval [CI], 0.94-0.99), AKI (RR, 0.97; 95% CI, 0.96-0.98), ARDS (RR, 0.98; 95% CI, 0.97-0.99), MOF (RR, 0.94; 95% CI, 0.91-0.97), and sepsis (RR, 0.98; 95% CI, 0.96-0.99), but not venous thromboembolism (RR, 0.99; 95% CI, 0.96-1.03). CONCLUSION: Earlier time to hemostasis was independently associated with decreased incidence of 30-day mortality, AKI, ARDS, MOF, and sepsis in bleeding trauma patients. Time to hemostasis should be considered as an endpoint in trauma studies and as a potential quality indicator. LEVEL OF EVIDENCE: Therapeutic/care management, level III.

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.

Protocol for a pilot randomized controlled trial comparing plasma with balanced crystalloid resuscitation in surgical and trauma patients with septic shock.

BACKGROUND: Septic shock is a public health problem with high mortality. There remains a knowledge gap regarding the optimal resuscitation fluid to improve clinical outcomes, and the underlying mechanism by which fluids exert their effect. Shock-induced endotheliopathy (SHINE) is thought to be a shared pathophysiologic mechanism associated with worsened outcomes in critically ill trauma and sepsis patients. SHINE is characterized by breakdown of the glycocalyx-a network of membrane-bound proteoglycans and glycoproteins that covers the endothelium. This has been associated with capillary leakage and microvascular thrombosis, organ dysfunction, and mortality. Biomarkers of SHINE have been shown to correlate with clinical outcomes in patients with septic shock. Interventions to mitigate SHINE may improve outcomes in patients with septic shock. In surgical/trauma patients with septic shock, initial plasma resuscitation as compared with balanced crystalloid (BC) resuscitation will mitigate biomarkers of SHINE and improve clinical outcomes. METHODS: A pilot, single-center randomized controlled trial (RCT) will compare initial plasma to BC resuscitation in surgical and trauma patients with septic shock. Patients will be enrolled based on a Sepsis Screening Score of ≥4 with a suspected source of infection. Patient randomization only occurs if they meet the criteria: (1) hypotension with mean arterial pressure <65 mm Hg, and (2) evidence of hypoperfusion including lactic acid >4 mmol/L, altered mental status or decreased urine output of <0.5 mL/kg in the past hour. RESULTS: The primary outcome is a reduction in serum biomarkers at 6 hours. Secondary outcomes will include clinical outcomes such as intensive care unit-free days, organ dysfunction, and in-hospital mortality. DISCUSSION: This trial will provide insights into the effects of initial plasma resuscitation on SHINE. Furthermore, it will provide unbiased estimates regarding the feasibility, safety, and clinical efficacy of plasma resuscitation in septic shock on which to base subsequent adequately powered multicenter RCTs. TRAIL REGISTRATION NUMBER: ClinicalTrials.gov (NCT03366220).

Multi-modal Analgesic Strategies for Trauma (MAST): protocol for a pragmatic randomized trial.

BACKGROUND: Pain management after injury is critically important for functional recovery. Although opioids have been a mainstay for treatment of pain, they are associated with adverse events and may contribute to long-term use or abuse. Opioid-minimizing multimodal pain regimens have the potential to reduce exposure to opioids without compromising pain control. This article details an ongoing clinical trial comparing two pill-based, opioid-minimizing, multimodal pain strategies. METHODS: This is a single-center, parallel-group, randomized, controlled comparative effectiveness trial comparing two multimodal pain regimens in adult trauma patients. All patients 16 years and older admitted to the Red Duke Trauma Institute are eligible unless they are pregnant, a prisoner, under observation status, or a non-acute trauma patient. At admission to the trauma service, patients are enrolled and randomized to one of two multimodal pain regimens. The primary outcome is opioid use, measured by morphine milligram equivalents per patient per day. The secondary outcomes include pain scores, ventilator days, hospital and intensive care unit lengths of stay, occurrence of opioid-related complications, hospital and pharmacy costs, and incidence of hospital discharge with opioid prescription. Outcomes will be compared using Bayesian methods. DISCUSSION: This trial will determine the effectiveness of two multimodal pain treatment strategies on reducing in-hospital opioid exposure in adult trauma patients. Furthermore, it will compare the two strategies on pain control and patient safety. Knowledge gained in this study can improve quality of care at this hospital and other trauma centers regardless of which medication regimen proves superior.

Abnormalities of laboratory coagulation tests versus clinically evident coagulopathic bleeding: results from the prehospital resuscitation on helicopters study (PROHS).

BACKGROUND: Laboratory-based evidence of coagulopathy (LC) is observed in 25-35% of trauma patients, but clinically-evident coagulopathy (CC) is not well described. METHODS: Prospective observational study of adult trauma patients transported by helicopter from the scene to nine Level 1 trauma centers in 2015. Patients meeting predefined highest-risk criteria were divided into CC+ (predefined as surgeon-confirmed bleeding from uninjured sites or injured sites not controllable by sutures) or CC-. We used a mixed-effects, Poisson regression with robust error variance to test the hypothesis that abnormalities on rapid thrombelastography (r-TEG) and international normalized ratio (INR) were independently associated with CC+. RESULTS: Of 1,019 highest-risk patients, CC+ (n=41, 4%) were more severely injured (median ISS 32 vs 17), had evidence of LC on r-TEG and INR, received more transfused blood products at 4 hours (37 vs 0 units), and had greater 30-day mortality (59% vs 12%) than CC- (n=978, 96%). The overall incidence of LC was 39%. 30-day mortality was 22% vs 9% in those with and without LC. In two separate models, r-TEG K-time >2.5 min (RR 1.3, 95% CI 1.1-1.7), r-TEG mA <55 mm (RR 2.5, 95% CI 2.0-3.2), platelet count <150 x 109/L (RR 1.2, 95% CI 1.1-1.3), and INR >1.5 (RR 5.4, 95% CI 1.8-16.3) were independently associated with CC+. A combined regression model was not generated because too few patients underwent both r-TEG and INR. CONCLUSION: CC was rare compared to LC. CC was associated with poor outcomes and impairment of both clotting factor and platelet-mediated coagulation components.

Multicenter retrospective study of noncompressible torso hemorrhage: Anatomic locations of bleeding and comparison of endovascular versus open approach.

BACKGROUND: Rational development of technology for rapid control of noncompressible torso hemorrhage (NCTH) requires detailed understanding of what is bleeding. Our objectives were to describe the anatomic location of truncal bleeding in patients presenting with NCTH and compare endovascular (ENDO) management versus open (OPEN) management. METHODS: This is a retrospective study of adult trauma patients with NCTH admitted to four urban Level I trauma centers in the Houston and San Antonio metropolitan areas in 2008 to 2012. Inclusion criteria include named axial torso vessel disruption, Abbreviated Injury Scale chest or abdomen score of 3 or higher with shock (base excess, <-4) or truncal operation in 90 minutes or less, or pelvic fracture with ring disruption. Exclusion criteria include isolated hip fractures, falls from standing, or prehospital cardiopulmonary resuscitation. After dichotomizing into OPEN, ENDO, and resuscitative thoracotomy (RT) groups based on the initial approach to control NCTH, a mixed-effects Poisson regression with robust error variance (controlling for age, mechanism, Injury Severity Score, shock, hypotension, and severe head injury as fixed effects and site as a random effect) was used to test the hypothesis that ENDO was associated with reduced in-hospital mortality in NCTH patients. RESULTS: Five hundred forty-three patients with NCTH underwent ENDO (n = 166, 31%), OPEN (n = 309, 57%), or RT (n = 68, 12%). Anatomic bleeding locations were 25% chest, 41% abdomen, and 31% pelvis. ENDO was used to treat relatively few types of vascular injuries, whereas OPEN and RT injuries were more diverse. ENDO patients had more blunt trauma (95% vs. 34% vs. 32%); severe injuries (median Injury Severity Score, 34 vs. 27 vs. 21), and increased time to intervention (median, 298 vs. 92 vs. 51 minutes) compared with OPEN and RT. Mortality was 15% versus 20% versus 79%. ENDO was associated with decreased mortality compared to OPEN (relative risk, 0.58; 95% confidence interval, 0.46-0.73). CONCLUSION: Although ENDO may reduce mortality in NCTH patients, significant group differences limit the generalizability of this finding. LEVEL OF EVIDENCE: Therapeutic, level V.