Effect of Thromboprophylaxis on Clinical Outcomes After COVID-19 Hospitalization.

BACKGROUND: Patients hospitalized with COVID-19 have an increased incidence of thromboembolism. The role of extended thromboprophylaxis after hospital discharge is unclear. OBJECTIVE: To determine whether anticoagulation is superior to placebo in reducing death and thromboembolic complications among patients discharged after COVID-19 hospitalization. DESIGN: Prospective, randomized, double-blind, placebo-controlled clinical trial. (ClinicalTrials.gov: NCT04650087). SETTING: Done during 2021 to 2022 among 127 U.S. hospitals. PARTICIPANTS: Adults aged 18 years or older hospitalized with COVID-19 for 48 hours or more and ready for discharge, excluding those with a requirement for, or contraindication to, anticoagulation. INTERVENTION: 2.5 mg of apixaban versus placebo twice daily for 30 days. MEASUREMENTS: The primary efficacy end point was a 30-day composite of death, arterial thromboembolism, and venous thromboembolism. The primary safety end points were 30-day major bleeding and clinically relevant nonmajor bleeding. RESULTS: Enrollment was terminated early, after 1217 participants were randomly assigned, because of a lower than anticipated event rate and a declining rate of COVID-19 hospitalizations. Median age was 54 years, 50.4% were women, 26.5% were Black, and 16.7% were Hispanic; 30.7% had a World Health Organization severity score of 5 or greater, and 11.0% had an International Medical Prevention Registry on Venous Thromboembolism risk prediction score of greater than 4. Incidence of the primary end point was 2.13% (95% CI, 1.14 to 3.62) in the apixaban group and 2.31% (CI, 1.27 to 3.84) in the placebo group. Major bleeding occurred in 2 (0.4%) and 1 (0.2%) and clinically relevant nonmajor bleeding occurred in 3 (0.6%) and 6 (1.1%) apixaban-treated and placebo-treated participants, respectively. By day 30, thirty-six (3.0%) participants were lost to follow-up, and 8.5% of apixaban and 11.9% of placebo participants permanently discontinued the study drug treatment. LIMITATIONS: The introduction of SARS-CoV-2 vaccines decreased the risk for hospitalization and death. Study enrollment spanned the peaks of the Delta and Omicron variants in the United States, which influenced illness severity. CONCLUSION: The incidence of death or thromboembolism was low in this cohort of patients discharged after hospitalization with COVID-19. Because of early enrollment termination, the results were imprecise and the study was inconclusive. PRIMARY FUNDING SOURCE: National Institutes of Health.

Emergency Department Length of Stay and Mortality in Critically Injured Patients.

OBJECTIVE: Multicenter data from 2 decades ago demonstrated that critically ill and injured patients spending more than 6 hours in the emergency department (ED) before transfer to the intensive care unit (ICU) had higher mortality rates. A contemporary analysis of ED length of stay in critically injured patients at American College of Surgeons' Trauma Quality Improvement Program (ACS-TQIP) centers was performed to test whether prolonged ED length of stay is still associated with mortality. METHODS: This was an observational cohort study of critically injured patients admitted directly to ICU from the ED in ACS-TQIP centers from 2010-2015. Spending more than 6 hours in the ED was defined as prolonged ED length of stay. Patients with prolonged ED length of stay were matched to those with non-prolonged ED length of stay and mortality was compared. MAIN RESULTS: A total of 113,097 patients were directly admitted from the ED to the ICU following injury. The median ED length of stay was 167 minutes. Prolonged ED length of stay occurred in 15,279 (13.5%) of patients. Women accounted for 29.4% of patients with prolonged ED length of stay but only 25.8% of patients with non-prolonged ED length of stay, P < 0.0001. Mortality rates were similar after matching-4.5% among patients with prolonged ED length of stay versus 4.2% among matched controls. Multivariable logistic regression of the matched cohorts demonstrated prolonged ED length of stay was not associated with mortality. However, women had higher adjusted mortality compared to men Odds Ratio = 1.41, 95% Confidence Interval 1.28 -1.61, P < 0.0001. CONCLUSION: Prolonged ED length of stay is no longer associated with mortality among critically injured patients. Women are more likely to have prolonged ED length of stay and mortality.

Improving Efficiency and Meeting Expectations Without Compromising Care on Trauma Surgical Rounds.

BACKGROUND: Care teams on complex surgical services face a growing list of competing expectations. Approaches to quality improvement must use minimal resources and address both system and human requirements to meet expectations without compromising care. The purpose of this study was to demonstrate that iterative prototyping, combined with a rigorous quantitative evaluation approach, can effectively improve system and stakeholder efficiency on daily trauma surgical rounds at an academic safety-net hospital and level 1 trauma center. MATERIALS AND METHODS: This study occurred between May 2017 and October 2017 at the Zuckerberg San Francisco General Hospital and Trauma Center. Care team members rounding on the trauma service included attending trauma surgeons, fellows, residents, interns, nurse practitioners, pharmacists, and medical students. We used human-centered design to develop and test solutions to improve the surgical rounding process. Each prototype was evaluated using qualitative design research methods, which informed the next iteration. Time observations of rounding activities were adopted from the Lean methodology and tracked before and after implementation. Intern work hours, on-time operative starts, and discharge order times were also tracked before and after implementation. RESULTS: Four prototypes were designed and iteratively implemented, producing care team satisfaction by the end of the implementation period. Discharge order times decreased by a median of 58 min, intern work hours were decreased by 97 min/d, and first operative case on-time starts increased from 40% to 63% (P < 0.05). The time spent on clarifications decreased by 4.7% (P < 0.05), allowing for more time to discuss care plans with the patients themselves. CONCLUSIONS: Iterative prototyping as part of a human-centered design methodology is a powerful tool to address complex systems with diverse interests and competing priorities. Rapid, in-context prototyping is feasible on a complex trauma surgical service and can result in improved workflows and efficiency for the system and its stakeholders.

Beyond emergency surgery: redefining acute care surgery.

BACKGROUND: Considerable debate exists regarding the definition, skill set, and training requirements for the new specialty of acute care surgery (ACS). We hypothesized that a patient subset could be identified that requires a level of care beyond general surgical training and justifies creation of this new specialty. MATERIALS AND METHODS: Reviewed patient admissions over 1-y to the only general surgical service at a level I trauma center-staffed by trauma and/or critical care trained physicians. Patients classified as follows: trauma, ACS, emergency general (EGS), or elective surgery. ACS patients are nonelective, nontrauma patients with significantly altered physiology requiring intensive care unit admission and/or specific complex operative interventions. Differences in demographics, hospital course, and outcomes were analyzed. RESULTS: In-patient service evaluated approximately 5500 patients, including 3300 trauma patients. A total of 2152 admissions include 37% trauma, 30% elective, 28% EGS, and 4% ACS. ACS and trauma patients were more likely to require multiple operations (ACS relative risk [RR] = 11.5; trauma RR = 5.7, P < 0.0001), have longer hospital and intensive care unit length of stay, and higher mortality (P < 0.0001). They were less likely to be discharged home (ACS RR = 0.75; trauma RR = 0.67, P < 0.0001) compared with that of the EGS group. EGS and elective patients were most similar to each other in multiple areas. CONCLUSIONS: ACS and EGS patients represent distinct patient cohorts, as reflected by significant differences in critical care needs, likelihood of multiple operations, and need for postdischarge rehabilitation. The skills required to care for ACS patients, including ability to rescue from complications and provide critical care, differ from those required for EGS patients and supports development of ACS training and regionalization of care.

Fibrinolysis Resistance After Injury Is a Risk Factor for a Hospital-Acquired Pneumonia-Like Disease Pattern.

Background: Pneumonia is associated with increased morbidity and costs in the intensive care unit (ICU). Its early identification is key for optimal outcomes, but early biomarkers are lacking. Studies suggest that fibrinolysis resistance (FR) after major abdominal surgery is linked to an increased risk of infection. Patients and Methods: Patients in a randomized controlled trial for hemorrhagic shock were evaluated for FR. Fibrinolysis resistance was quantified by thrombelastography with exogenous tissue plasminogen activator (tPA-TEG) at 24- and 48-hours post-injury and measuring LY30 (%). A receiver-operating characteristics (ROC) curve analysis was used to identify a cutoff for increased risk of pneumonia, which was then validated in ICU patients at risk for venous thromboembolism (VTE). Multivariable logistic regression was used to control for confounders. Results: Forty-nine patients in the hemorrhagic shock cohort had tPA-TEGs at 24- and 48-hours (median ISS, 27; 7% pneumonia). A composite tPA-TEG LY30 of less than 4% at 24 and 48 hours was found to be the optimal cutoff for increased risk of pneumonia. This cohort had a seven-fold increased rate of pneumonia (4% vs. 28%; p = 0.048). Eighty-eight patients in the VTE cohort had tPA-TEGs at 24 and 48 hours post-ICU admission (median ISS, 28; 6% pneumonia). The tPA-TEG LY30 of less than 4% was associated with a 10-fold increased rate of pneumonia (19% vs. 1.5%; p = 0.002). In patients with traumatic brain injury, the same association was found (33% vs. 3.2%; p = 0.006). Adjusting for confounders, the tPA-TEG persisted as a substantial risk factor for pneumonia (adjusted odds ratio [OR], 35.7; 95% confidence interval [CI], 1.9-682; p = 0.018). Conclusions: Fibrinolysis resistance quantified by tPA-TEG within 48 hours of ICU admission is associated with an increased risk of pneumonia in patients in hemorrhagic shock and those at risk for VTE. Prospective validation of the tPA-TEG LY30 optimal cutoff for pneumonia and further investigation into whether endogenous FR is a cause of an altered immunity is warranted.

Weight-based enoxaparin thromboprophylaxis in young trauma patients: analysis of the CLOTT-1 registry.

Introduction: Optimal venous thromboembolism (VTE) enoxaparin prophylaxis dosing remains elusive. Weight-based (WB) dosing safely increases anti-factor Xa levels without the need for routine monitoring but it is unclear if it leads to lower VTE risk. We hypothesized that WB dosing would decrease VTE risk compared with standard fixed dosing (SFD). Methods: Patients from the prospective, observational CLOTT-1 registry receiving prophylactic enoxaparin (n=5539) were categorized as WB (0.45-0.55 mg/kg two times per day) or SFD (30 mg two times per day, 40 mg once a day). Multivariate logistic regression was used to generate a predicted probability of VTE for WB and SFD patients. Results: Of 4360 patients analyzed, 1065 (24.4%) were WB and 3295 (75.6%) were SFD. WB patients were younger, female, more severely injured, and underwent major operation or major venous repair at a higher rate than individuals in the SFD group. Obesity was more common among the SFD group. Unadjusted VTE rates were comparable (WB 3.1% vs. SFD 3.9%; p=0.221). Early prophylaxis was associated with lower VTE rate (1.4% vs. 5.0%; p=0.001) and deep vein thrombosis (0.9% vs. 4.4%; p<0.001), but not pulmonary embolism (0.7% vs. 1.4%; p=0.259). After adjustment, VTE incidence did not differ by dosing strategy (adjusted OR (aOR) 0.75, 95% CI 0.38 to 1.48); however, early administration was associated with a significant reduction in VTE (aOR 0.47, 95% CI 0.30 to 0.74). Conclusion: In young trauma patients, WB prophylaxis is not associated with reduced VTE rate when compared with SFD. The timing of the initiation of chemoprophylaxis may be more important than the dosing strategy. Further studies need to evaluate these findings across a wider age and comorbidity spectrum. Level of evidence: Level IV, therapeutic/care management.

Does tranexamic acid increase venous thromboembolism risk among trauma patients? A prospective multicenter analysis across 17 level I trauma centers.

IMPORTANCE: The early use of tranexamic acid (TXA) has demonstrated benefit among some trauma patients in hemorrhagic shock. The association between TXA administration and thromboembolic events (including deep vein thrombosis (DVT), pulmonary embolism (PE) and pulmonary thrombosis (PT)) remains unclear. We aimed to characterize the risk of venous thromboembolism (VTE) subtypes among trauma patients receiving TXA and to determine whether TXA is associated with VTE risk and mortality. METHODS: We analyzed a prospective, observational, multicenter cohort data from the Consortium of Leaders in the Study of Traumatic Thromboembolism (CLOTT) study group. The study was conducted across 17 US level I trauma centers between January 1, 2018, and December 31,2020. We studied trauma patients ages 18-40 years, admitted for at least 48 h with a minimum of 1 VTE risk factor and followed until hospital discharge or 30 days. We compared TXA recipients to non-recipients for VTE and mortality using inverse probability weighted Cox models. The primary outcome was the presence of documented venous thromboembolism (VTE). The secondary outcome was mortality. VTE was defined as DVT, PE, or PT. RESULTS: Among the 7,331 trauma patients analyzed, 466 (6.4%) received TXA. Patients in the TXA group were more severely injured than patients in the non-TXA group (ISS 16+: 69.1% vs. 48.5%, p < 0.001) and a higher percentage underwent a major surgical procedure (85.8% vs. 73.6%, p < 0.001). Among TXA recipients, 12.5% developed VTE (1.3% PT, 2.4% PE, 8.8% DVT) with 5.6% mortality. In the non-TXA group, 4.6% developed VTE (1.1% PT, 0.5% PE, 3.0% DVT) with 1.7% mortality. In analyses adjusting for patient demographic and clinical characteristics, TXA administration was not significantly associated with VTE (aHR 1.00, 95%CI: 0.69-1.46, p = 0.99) but was significantly associated with increased mortality (aHR 2.01, 95%CI: 1.46-2.77, p < 0.001). CONCLUSION: TXA was not clearly identified as an independent risk factor for VTE in adjusted analyses, but the risk of VTE among trauma patients receiving TXA remains high (12.5%). This supports the judicious use of TXA in resuscitation, with consideration of early initiation of DVT prophylaxis in this high-risk group.

Venous thromboembolism risk after spinal cord injury: A secondary analysis of the CLOTT study.

INTRODUCTION: Patients with spinal cord injury (SCI) are at high risk of venous thromboembolism (VTE). Pharmacologic VTE prophylaxis (VTEppx) is frequently delayed in patients with SCI because of concerns for bleeding risk. Here, we hypothesized that delaying VTEppx until >48 hours would be associated with increased risk of thrombotic events. METHODS: This is a secondary analysis of the 2018 to 2020 prospective, observational, cohort Consortium of Leaders in the Study of Traumatic Thromboembolism (CLOTT) study of patients aged 18 to 40 years, at 17 US level 1 trauma centers. Patients admitted for >48 hours with documented SCI were evaluated. Timing of initiation of VTEppx, rates of thrombotic events (deep vein thrombosis [DVT] and pulmonary embolism [PE]), and missed VTEppx doses were analyzed. The primary outcome was VTE (DVT + PE). RESULTS: There were 343 patients with SCI. The mean ± SD age was 29.0 ± 6.6 years, 77.3% were male, and 78.7% sustained blunt mechanism. Thrombotic events occurred in 33 patients (9.6%): 30 DVTs (8.7%) and 3 PEs (0.9%). Venous thromboembolism prophylaxis started at ≤24 hours in 21.3% of patients and 49.3% at ≤48 hours. The rate of VTE for patients started on VTEppx ≤48 hours was 7.1% versus 12.1% if started after 48 hours ( p = 0.119). After adjusting for differences in risk factors between cohorts, starting ≤48 hours was independently associated with fewer VTEs (odds ratio, 0.45; 95% confidence interval, 0.101-0.978; p = 0.044). Unfractionated heparin was associated with a VTE rate of 21.0% versus 7.5% in those receiving enoxaparin as prophylaxis ( p = 0.003). Missed doses of VTEppx were common (29.7%) and associated with increased thrombotic events, although this was not significant on multivariate analysis. CONCLUSION: Rates of thrombotic events in patients with SCI are high. Prompt initiation of VTEppx with enoxaparin and efforts aimed at avoiding missed doses are critical to limit thrombotic events in these high-risk patients. LEVEL OF EVIDENCE: Prognostic and Epidemiological; Level IV.

Early venous thromboembolism prophylaxis in patients with trauma intracranial hemorrhage: Analysis of the prospective multicenter Consortium of Leaders in Traumatic Thromboembolism study.

BACKGROUND: The optimal time to initiate venous thromboembolism prophylaxis (VTEp) for patients with intracranial hemorrhage (ICH) is controversial and must balance the risks of VTE with potential progression of ICH. We sought to evaluate the efficacy and safety of early VTEp initiation after traumatic ICH. METHODS: This is a secondary analysis of the prospective multicenter Consortium of Leaders in the Study of Thromboembolism study. Patients with head Abbreviated Injury Scale score of > 2 and with immediate VTEp held because of ICH were included. Patients were divided into VTEp ≤ or >48 hours and compared. Outcome variables included overall VTE, deep vein thrombosis (DVT), pulmonary embolism, progression of intracranial hemorrhage (pICH), or other bleeding events. Univariate and multivariate logistic regressions were performed. RESULTS: There were 881 patients in total; 378 (43%) started VTEp ≤48 hours (early). Patients starting VTEp >48 hours (late) had higher VTE (12.4% vs. 7.2%, p = 0.01) and DVT (11.0% vs. 6.1%, p = 0.01) rates than the early group. The incidence of pulmonary embolism (2.1% vs. 2.2%, p = 0.94), pICH (1.9% vs. 1.8%, p = 0.95), or any other bleeding event (1.9% vs. 3.0%, p = 0.28) was equivalent between early and late VTEp groups. On multivariate logistic regression analysis, VTEp >48 hours (odds ratio [OR], 1.86), ventilator days >3 (OR, 2.00), and risk assessment profile score of ≥5 (OR, 6.70) were independent risk factors for VTE (all p < 0.05), while VTEp with enoxaparin was associated with decreased VTE (OR, 0.54, p < 0.05). Importantly, VTEp ≤48 hours was not associated with pICH (OR, 0.75) or risk of other bleeding events (OR, 1.28) (both p = NS). CONCLUSION: Early initiation of VTEp (≤48 hours) for patients with ICH was associated with decreased VTE/DVT rates without increased risk of pICH or other significant bleeding events. Enoxaparin is superior to unfractionated heparin as VTE prophylaxis in patients with severe TBI. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level IV.

Military-civilian partnerships and the clinical readiness mission: A preliminary study from the Military Health System and the American College of Surgeons.

BACKGROUND: The Blue Book , published in conjunction with the Military Health System Strategic Partnership with the American College of Surgeons, serves as a reference manual for institutions wishing to establish a military-civilian partnership (MCP). To evaluate the applicability of the criteria contained in the Blue Book , we created a survey to be distributed to MCP military surgeons and their civilian host champions. METHODS: E-mail surveys were sent to MCP military surgeons and civilian host champions. Military surgeons were queried about basic demographic information and aspects of the MCP including type, duration of assignment, onboarding, malpractice coverage, and billing for services. We gathered information on the role of military surgeons at the MCP, workload information, and trauma cases. The civilian host champions survey focused on institutional activities including trauma surgical volume, clinical and educational opportunities for the military surgeons, and exposure to research. Military-civilian partnership military surgeons and civilian host champions were questioned on program attributes: administrative support, budget, and profile of the program within the institution. RESULTS: Ten MCP military surgeons and 7 host champions completed surveys. The majority of military surgeons were assigned to the MCP for a 3-year instructor role (90%), and most were trauma surgeons (80%). Clinical activities for the military surgeon were where 60% spent ≥13 weeks annually on trauma. Military surgeons identified host program support in academic growth, deployment preparation, and sense of value at the MCP as positive attributes. Civilian host champions unanimously reported that exposure to research, opportunities to lead trauma teams, dedicated intensive care unit time, and patient volume were positive program attributes. CONCLUSION: This preliminary survey demonstrates that the criteria put forth in the Blue Book align with experiences of MCP military surgeons and host champions. Continued development of this survey and others like it may be useful in the MCP program selection and evaluation process. LEVEL OF EVIDENCE: Therapeutic/care management; Level V.

Postinjury platelet aggregation and venous thromboembolism.

BACKGROUND: Posttraumatic venous thromboembolism (VTE) remains prevalent in severely injured patients despite chemoprophylaxis. Importantly, although platelets are central to thrombosis, they are not routinely targeted in prevention of posttraumatic VTE. Furthermore, platelets from injured patients show ex vivo evidence of increased activation yet impaired aggregation, consistent with functional exhaustion. However, the relationship of this platelet functional phenotype with development of posttraumatic VTE is unknown. We hypothesized that, following injury, impaired ex vivo platelet aggregation (PA) is associated with the development of posttraumatic VTE. METHODS: We performed a secondary analysis of 133 severely injured patients from a prospective observational study investigating coagulation and inflammation (2011-2019). Platelet aggregation in response to stimulation with adenosine diphosphate (ADP), collagen, and thrombin was measured at presentation (preresuscitation) and 24 hours (postresuscitation). Viscoelastic clot strength and lysis were measured in parallel by thromboelastography. Multivariable regression examined relationships between PA at presentation, 24 hours, and the change (δ) in PA between presentation and 24 hours with development of VTE. RESULTS: The 133 patients were severely injured (median Injury Severity Score, 25), and 14% developed VTE (all >48 hours after admission). At presentation, platelet count and PA were not significantly different between those with and without incident VTE. However, at 24 hours, those who subsequently developed VTE had significantly lower platelet counts (126 × 10 9 /L vs. 164 × 10 9 /L, p = 0.01) and lower PA in response to ADP ( p < 0.05), collagen ( p < 0.05), and thrombin ( p = 0.06). Importantly, the magnitude of decrease in PA (δ) from presentation to 24 hours was independently associated with development of VTE (adjusted odds ratios per 10 aggregation unit decrease: δ-ADP, 1.31 [ p = 0.03]; δ-collagen, 1.36 [ p = 0.01]; δ-thrombin, 1.41 [ p < 0.01]). CONCLUSION: Severely injured patients with decreasing ex vivo measures of PA despite resuscitation have an increased risk of developing VTE. This may have implications for predicting development of VTE and for studying platelet targeted chemoprophylaxis regimens. LEVEL OF EVIDENCE: Prognostic/Epidemiological; Level III.

Tissue plasminogen activator resistance is an early predictor of posttraumatic venous thromboembolism: A prospective study from the CLOTT research group.

BACKGROUND: Venous thromboembolism (VTE) remains a frequent postinjury complication with well established but nonmodifiable risk factors. We hypothesized that fibrinolysis shutdown (SD) as measured by thromboelastography (TEG) would be an independent risk factor for VTE in trauma patients. METHODS: A subgroup of patients enrolled in the CLOTT-2 (Consortium of Leaders in the Study of Traumatic Thromboembolism 2), multicenter prospective cohort study had kaolin TEG and tissue plasminogen activator (tPA)-TEG data at 12 and 24 hours postadmission. Patients underwent a screening duplex venous ultrasound examination during the first week unless clot was already detected on computed tomography. Injury factors associated with early fibrinolysis SD (defined as kaolin TEG Ly30 ≤0.3%) and/or tPA resistance (tPA-R) (defined as kaolin TEG with tPA 75 ng Ly30 <2.1%) were investigated as was the association of the TEG measurements with the development of VTE. RESULTS: A total of 141 patients had both TEG measurements at 24 hours, and 135 had both TEG measurements at 12 hours. Shutdown was evident at 12 hours in 71 of 135 (52.6%) patients and in 62 of 141 (44%) at 24 hours. Tissue plasminogen activator resistance was found in 61 of 135 (45.2%) at 12 hours and in 49 of 141 (34.3%) at 24 hours. Factors significantly associated with SD included receiving >4 U of FFP in the first 24 hours, the presence of a major brain injury or pelvic fracture, and the need for major surgery. In contrast, factors significantly associated with early tPA-R included >4 U of red blood cells transfused in the first 24 hours and the presence of a major chest injury or long bone fracture. Deep vein thrombosis was detected in 15 patients and pulmonary clots in 5 (overall VTE rate, 14.2%). Tissue plasminogen activator resistance at 12 hours was found to be an independent risk factor for VTE (hazard ratio, 5.57; 95% confidence interval, 1.39-22.39). CONCLUSION: Early development of a hypercoagulable state as defined by tPA-R at 12 hours after admission represents a potentially modifiable risk factor for postinjury VTE. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level II.

Challenging Traditional Paradigms in Posttraumatic Pulmonary Thromboembolism.

Importance: Pulmonary clots are seen frequently on chest computed tomography performed after trauma, but recent studies suggest that pulmonary thrombosis (PT) and pulmonary embolism (PE) after trauma are independent clinical events. Objective: To assess whether posttraumatic PT represents a distinct clinical entity associated with the nature of the injury, different from the traditional venous thromboembolic paradigm of deep venous thrombosis (DVT) and PE. Design, Setting, and Participants: This prospective, observational, multicenter cohort study was conducted by the Consortium of Leaders in the Study of Traumatic Thromboembolism (CLOTT) study group. The study was conducted at 17 US level I trauma centers during a 2-year period (January 1, 2018, to December 31, 2020). Consecutive patients 18 to 40 years of age admitted for a minimum of 48 hours with at least 1 previously defined trauma-associated venous thromboembolism (VTE) risk factor were followed up until discharge or 30 days. Exposures: Investigational imaging, prophylactic measures used, and treatment of clots. Main Outcomes and Measures: The main outcomes of interest were the presence, timing, location, and treatment of any pulmonary clots, as well as the associated injury-related risk factors. Secondary outcomes included DVT. We regarded pulmonary clots with DVT as PE and those without DVT as de novo PT. Results: A total of 7880 patients (mean [SD] age, 29.1 [6.4] years; 5859 [74.4%] male) were studied, 277 with DVT (3.5%), 40 with PE (0.5%), and 117 with PT (1.5%). Shock on admission was present in only 460 patients (6.2%) who had no DVT, PT, or PE but was documented in 11 (27.5%) of those with PE and 30 (25.6%) in those with PT. Risk factors independently associated with PT but not DVT or PE included shock on admission (systolic blood pressure <90 mm Hg) (odds ratio, 2.74; 95% CI, 1.72-4.39; P < .001) and major chest injury with Abbreviated Injury Score of 3 or higher (odds ratio, 1.72; 95% CI, 1.16-2.56; P = .007). Factors associated with the presence of PT on admission included major chest injury (14 patients [50.0%] with or without major chest injury with an Abbreviated Injury Score >3; P = .04) and major venous injury (23 [82.1%] without major venous injury and 5 [17.9%] with major venous injury; P = .02). No deaths were attributed to PT or PE. Conclusions and Relevance: To our knowledge, this CLOTT study is the largest prospective investigation in the world that focuses on posttraumatic PT. The study suggests that most pulmonary clots are not embolic but rather result from inflammation, endothelial injury, and the hypercoagulable state caused by the injury itself.

Three thousand seven hundred thirty-eight posttraumatic pulmonary emboli: a new look at an old disease.

OBJECTIVE: This study was undertaken to determine the current incidence of pulmonary embolism (PE) and its attributable mortality after injury. BACKGROUND: Despite compliance with prophylactic measures, PE remains a threat to postinjury recovery. We hypothesized that the liberal use of chest computed tomography after injury has resulted in an increased rate of detection of PE but that the mortality attributable to PE has decreased over the past decade. We also postulated that the risk factors for posttraumatic PE might be different from those for deep venous thrombosis (DVT). METHODS: We examined demographics, injury data, risk factors, and outcomes from patients with DVT and PE compiled in the recent years (2007-2009) in the National Trauma Data Bank (NTDB). For comparison, we used patient data entered into NTDB from 1994 to 2001. Statistical models were created to examine the predictors of DVT and PE and PE-related mortality. RESULTS: Among 888,652 patients in the current NTDB cohort, there were 9398 episodes of DVT (1.06%) and 3738 of PE (0.42%). Although many risk factors overlapped, a severe chest injury (Abbreviated Injury Score ≥ 3) conferred a much higher risk of PE than DVT. When comparing results from centers that had contributed to both data sets, there was a more than 2-fold increase in PE occurrence in the current cohort (0.49% vs 0.21%, P < 0.01) but with a significant reduction in PE-adjusted mortality (odds ratio, 4.08 vs 2.42). CONCLUSIONS: The reported incidence of PE after trauma has more than doubled in recent years, while the PE-associated mortality has significantly decreased, suggesting that we are identifying a different disease entity or stage. Chest injuries convey a substantial risk for PE, a risk not likely to be diminished by leg compression devices or vena cava filters.

Finding the sweet spot: identification of optimal glucose levels in critically injured patients.

BACKGROUND: Conflicting data exist regarding optimal glycemic control in critically ill trauma patients. We therefore compared glucose parameters and outcomes among three different glycemic control regimens in a single trauma intensive care unit (ICU), hypothesizing that a moderate regimen would yield optimal avoidance of hyper- and hypoglycemia with equivalent outcomes when compared with a more aggressive approach. METHODS: We retrospectively reviewed 1,422 trauma patients with at least 3-day ICU stay and five glucose measurements from May 2001 to January 2010, spanning three nonoverlapping, sequential glucose control protocols: "relaxed," "aggressive," and "moderate." For each, we extracted mean blood glucose, hypoglycemic and hyperglycemic event frequency, and glucose variability and investigated their association with outcomes. RESULTS: Mortality was associated with elevated mean glucose (135.6 mg/dL vs. 126.2 mg/dL), more frequent hypoglycemic (2.67 ± 7 vs. 1.28 ± 5) and hyperglycemic (30.6 ± 28 vs. 16.0 ± 22 per 100 patient-ICU days) events, and higher glucose variability (37.1 ± 20 vs. 29.4 ± 20; all p < 0.001). Regression identified hyperglycemic episodes (p < 0.05) as an independent predictor of mortality. The "moderate" regimen had rare hyperglycemia, low glucose variability, and intermediate mean blood glucose range and frequency of hypoglycemia. Multiorgan failure and mortality did not differ between groups. CONCLUSIONS: Hyperglycemic events (glucose >180 mg/dL) most strongly predicted mortality. Of glucose control protocols analyzed, the "moderate" protocol had fewest hyperglycemic events. As outcomes were otherwise equivalent between "moderate" and "aggressive" protocols, we conclude that hyperglycemia can be safely avoided using a moderate glycemic control protocol without inducing hypoglycemia.

Screening for mental illness in a trauma center: rooting out a risk factor for unintentional injury.

BACKGROUND: Injury prevention and screening efforts have long targeted risk factors for injury recurrence. In a retrospective study, our group found that mental illness is an independent risk factor for unintentional injury and reinjury. The purpose of this study was to administer a standard validated screening instrument and psychosocial needs assessment to admitted patients who suffer unintentional injury. We aimed to prospectively measure the prevalence of mental illness. We hypothesize that systematic screening for psychiatric disorders in trauma patients is feasible and identifies people with preexisting mental illness as a high-risk group for unintentional injury. METHODS: In this prospective study, we recruited patients admitted to our Level I trauma center for unintentional injury for a period of 18 months. A bedside structured interview, including the Mini International Neuropsychiatric Interview, and a needs assessment were performed by lay research personnel trained by faculty from the Department of Psychiatry. The validated needs assessment questions were from the Camberwell Assessment of Need Short Appraisal Schedule instrument. Psychiatric screening and needs assessment results, as well as demographic characteristics are reported as descriptive statistics. RESULTS: A total of 1,829 people were screened during the study period. Of the 854 eligible people, 348 were able to be approached by researchers before discharge with a positive response rate of 63% (N = 219 enrolled). Interviews took 35 minutes ± 12 minutes. Chi-squared analysis revealed no difference in mechanism in those with mental illness versus no mental illness. Men were significantly more likely to be found to have a mental health disorder but when substance abuse was excluded, no difference was found. Four-way diagnostic grouping revealed the prevalence of mental illness detected. CONCLUSIONS: This inpatient pilot screening program prospectively identified preexisting mental illness as a risk factor for unintentional injury. Implementation of validated psychosocial and mental health screening instruments is feasible and efficient in the acute trauma setting. Administration of a validated mental health screening instrument can be achieved by training college-level research assistants. This system of screening can lead to identification and treatment of mental illness as a strategy for unintentional injury prevention.

Defining the limits of resuscitative emergency department thoracotomy: a contemporary Western Trauma Association perspective.

BACKGROUND: Since the promulgation of emergency department (ED) thoracotomy>40 years ago, there has been an ongoing search to define when this heroic resuscitative effort is futile. In this era of health care reform, generation of accurate data is imperative for developing patient care guidelines. The purpose of this prospective multicenter study was to identify injury patterns and physiologic profiles at ED arrival that are compatible with survival. METHODS: Eighteen institutions representing the Western Trauma Association commenced enrollment in January 2003; data were collected prospectively. RESULTS: During the ensuing 6 years, 56 patients survived to hospital discharge. Mean age was 31.3 years (15-64 years), and 93% were male. As expected, survival was predominant in those with thoracic injuries (77%), followed by abdomen (9%), extremity (7%), neck (4%), and head (4%). The most common injury was a ventricular stab wound (30%), followed by a gunshot wound to the lung (16%); 9% of survivors sustained blunt trauma, 34% underwent prehospital cardiopulmonary resuscitation (CPR), and the presenting base deficit was >25 mequiv/L in 18%. Relevant to futile care, there were survivors of blunt torso injuries with CPR up to 9 minutes and penetrating torso wounds up to 15 minutes. Asystole was documented at ED arrival in seven patients (12%); all these patients had pericardial tamponade and three (43%) had good functional neurologic recovery at hospital discharge. CONCLUSION: Resuscitative thoracotomy in the ED can be considered futile care when (a) prehospital CPR exceeds 10 minutes after blunt trauma without a response, (b) prehospital CPR exceeds 15 minutes after penetrating trauma without a response, and (c) asystole is the presenting rhythm and there is no pericardial tamponade.

Venous ligation versus venous repair: does the procedure impact venous thromboembolism risk?

BACKGROUND: Traumatic lower extremity venous injuries are most commonly managed with either a vein ligation or repair procedure. Venous injuries are associated with an increased risk of developing venous thromboembolisms (VTE), but little is understood with regard to how specific surgical treatments may impact the risk of developing either a deep vein thrombosis (DVT) or a pulmonary embolism (PE). In this study of lower extremity venous injuries, we hypothesized that venous ligation would be associated with an increased risk of DVT but a lower risk of PE when compared with venous repair. METHODS: Patients were identified from the National Trauma Data Bank (2008 to 2014) with at least one iliac, femoral, popliteal, or tibial venous injury and who received either a vein ligation or repair. The patients were then compared based on the type of procedure and the location of the injury to assess the risk of DVT and PE between the groups. RESULTS: A total of 1214 patients were identified. There was no difference between patients who received a vein ligation versus a repair with respect to age, injury severity score, or initial systolic blood pressure. There was no difference in the odds of developing either a DVT or PE between patients who were treated with vein ligation versus repair. There was also no difference in VTE rates when stratified by the location of the injury. CONCLUSIONS: In individuals with lower extremity venous injuries, there is no difference in the rate of DVT or PE complications when comparing venous repair and ligation procedures. The role of anticoagulation remains to be elucidated following operative treatment. LEVEL OF EVIDENCE: Therapeutic/Care Management, Level IV.

The DISTANCE study: Determining the impact of social distancing on trauma epidemiology during the COVID-19 epidemic-An interrupted time-series analysis.

BACKGROUND: The large-scale social distancing efforts to reduce SARS-CoV-2 transmission have dramatically changed human behaviors associated with traumatic injuries. Trauma centers have reported decreases in trauma volume, paralleled by changes in injury mechanisms. We aimed to quantify changes in trauma epidemiology at an urban Level I trauma center in a county that instituted one of the earliest shelter-in-place orders to inform trauma care during future pandemic responses. METHODS: A single-center interrupted time-series analysis was performed to identify associations of shelter-in-place with trauma volume, injury mechanisms, and patient demographics in San Francisco, California. To control for short-term trends in trauma epidemiology, weekly level data were analyzed 6 months before shelter-in-place. To control for long-term trends, monthly level data were analyzed 5 years before shelter-in-place. RESULTS: Trauma volume decreased by 50% in the week following shelter-in-place (p < 0.01), followed by a linear increase each successive week (p < 0.01). Despite this, trauma volume for each month (March-June 2020) remained lower compared with corresponding months for all previous 5 years (2015-2019). Pediatric trauma volume showed similar trends with initial decreases (p = 0.02) followed by steady increases (p = 0.05). Reductions in trauma volumes were due entirely to changes in nonviolent injury mechanisms, while violence-related injury mechanisms remained unchanged (p < 0.01). CONCLUSION: Although the shelter-in-place order was associated with an overall decline in trauma volume, violence-related injuries persisted. Delineating and addressing underlying factors driving persistent violence-related injuries during shelter-in-place orders should be a focus of public health efforts in preparation for future pandemic responses. LEVEL OF EVIDENCE: Epidemiological study, level III.