BACKGROUND:While the short-term risks of severe injury among older adults (age≥65) are well studied, little is known about long-term functional outcomes in this population. This knowledge gap impacts clinicians' ability to counsel patients and provide care aligned with their values. Our objective was to evaluate the association between severe injury and the likelihood of an older adult remaining alive and living in their own home five years later. METHODS:This was a retrospective, matched, population-based cohort study using administrative health data in a large regional trauma system (2006-2019). Community-dwelling older adults presenting with severe injury were matched with uninjured controls from the general population on age, sex, rurality, social determinants of health, comorbidity, and frailty. Time from injury to nursing home admission or death was compared between injured patients and matched controls using Kaplan-Meier analysis and extended Cox models. RESULTS:A total of 20,217 older adults admitted with severe injury were identified and matched with controls. Median ISS was 16 (IQR 16-21), and in-hospital mortality was 22.8% (n = 4615). After five years, the probability of remaining alive and home was 40% for all included cases and 64% for controls. Median time spent alive and home for cases was 2.7 years and exceeded the 5-year follow-up period for controls. While the risk of nursing home admission or death decreased over time, cases remained at elevated risk compared to controls for at least 5 years (years 2-5, HR 1.18, 95% CI 1.13-1.24). CONCLUSION:Most severely injured older adults survive to live in their own home for several years following injury. Nonetheless, patients who survive their injury have an increased risk of nursing home admission or death for at least five years. Long-term supports are necessary to ensure that patients remain alive and independent for years following their injury.

Hybrid operating rooms have been increasingly adopted in trauma centers to enable integrated surgical and endovascular care in hemorrhagic emergencies, but practical guidance on their operational implementation from the interventional radiology perspective remains limited. We describe our experience implementing a trauma hybrid operating room at an American College of Surgeons-verified Level I trauma center, addressing room design, zoning for rapid transitions between laparotomy and angioembolization, a mobile supply cart, and a pre-embolization checklist. We outline a training approach centered on radiation safety, sterility during procedural transitions, and simulation-based interdisciplinary coordination and discuss key implementation challenges, local activation criteria, and strategies to ensure timely access. This report focuses on operational design; institutional process metrics and clinical outcomes were not included. However, these operational lessons may be relevant to other centers seeking to develop or refine trauma hybrid operating room programs.

BACKGROUND:Over 7 million children are injured annually in the United States, leading to 500,000 disability-adjusted life years. Functional outcomes after injury, however, are not routinely measured. Whether disability is modifiable by trauma center care remains unclear. The purpose of this study was to assess variability between trauma centers in functional impairment rates. METHODS:The "Assessment of Health-Related Quality of Life and Functional Outcomes after Pediatric Trauma" prospective observational dataset was analyzed. Functional status among injured children (≤14 y) was assessed at discharge and 6-month follow-up using the Functional Status Scale (FSS). Multivariable logistic regression was used to calculate variability in FSS explained by nonmodifiable patient and injury characteristics. Propensity score modeling was used to estimate the expected functional impairment rates for each trauma center based on age, GCS, injury mechanism, number of body regions injured, and the presence of serious body region-specific injuries. Observed impairment rates were used to calculate observed-to-expected (O:E) ratios for risk-adjusted comparison between centers. RESULTS:The cohort included 427 patients from seven centers. Functional impairment (FSS ≥ 7) occurred in 217 (51%) children at discharge and in 81 of 324 (25%) at follow-up. Patient and injury characteristics explained 55% of the variability in FSS at discharge and 14% at follow-up. Unadjusted functional impairment differed between centers at discharge (range 36-70%, p =0.03), but not significantly at 6-month follow-up (range 12-36%, p =0.06). One high-impairment outlier center [O:E 1.38 (1.01, 1.84)] at discharge and one low-impairment outlier center [O:E 0.50 (0.23, 0.94)] at 6-month follow-up were identified. CONCLUSIONS:Most functional impairment after pediatric injury is explained by patient and injury characteristics, but variability in functional impairment exists between trauma centers after adjusting for these factors. Differences in functional outcomes between centers suggest that these outcomes are modifiable and are associated with the quality of trauma center care. ( J Trauma Acute Care Surg . 2026;101: 423-429. Copyright © 2026 Wolters Kluwer Health, LLC. All rights reserved.). LEVEL OF EVIDENCE:Prognostic/Epidemiological; Level III.

We read with significant concern the review by Millin et al. examining spinal motion restriction (SMR) for the prehospital management of patients with suspected spinal cord injury. This letter addresses the concerns of the American College of Surgeons Committee on Trauma.

BACKGROUND:The Functional Status Scale has been proposed for assessing functional outcomes after pediatric injury. The Functional Status Scale was developed in critically ill children with a score of 6 defined as normal and Functional Status Scale ≥8 as "abnormal." Previous work using this definition has shown that 51% of injured children with disability at follow-up did not have disability at hospital discharge, suggesting that defining Functional Status Scale ≥8 as "abnormal" may underestimate impairment in children with mild single-system disability (Functional Status Scale = 7). We aimed to determine appropriate classification of Functional Status Scale = 7 in injured children. We hypothesized that a Functional Status Scale = 7 at discharge would (1) correlate with previously established disability measures and (2) have higher rates of long-term disability than those with no disability (Functional Status Scale = 6) at discharge. METHODS:Data from the "Assessment of Health-Related Quality of Life and Functional Outcomes after Pediatric Trauma" prospective multicenter study were analyzed. Agreement was assessed between Functional Status Scale and Pediatric Overall Performance Category. Detectable disability at 6-month follow-up using Functional Status Scale and Pediatric Overall Performance Category was compared between children with discharge Functional Status Scale of 6, 7, or 8. RESULTS:Data from 427 children with available long-term follow-up were analyzed. Children with Functional Status Scale = 7 had detectable disability by Pediatric Overall Performance Category in 48% (55/114) at discharge and in 50% (20/40) at follow-up. Disability measured by Functional Status Scale and Pediatric Overall Performance Category at follow-up was higher among patients with discharge Functional Status Scale = 7 (26% and 19%) than those with discharge Functional Status Scale = 6 (13% and 3.8%; P ≤ .01). CONCLUSION:Classifying Functional Status Scale = 7 as "good" underestimates long-term injury-related disability. These findings support obtaining follow-up functional assessments on injured children with Functional Status Scale ≥7 at discharge.

Importance:Despite evidence demonstrating that severely injured patients treated at trauma centers have improved outcomes relative to those treated at nontrauma centers, rates of undertriage (transportation of severely injured patients to nontrauma centers) remain high. While national expert panels have developed field trauma triage (FTT) guidelines to aid in the triage of injured patients, the impact of the implementation of these guidelines on existing triage patterns is unknown. Objective:To examine the association between the 2015 update to FTT guidelines and trends in trauma triage in a mature trauma system in Ontario, Canada. Design, Setting, and Participants:This retrospective, population-based cohort study was conducted from April 1, 2009, to March 31, 2020, among individuals aged at least 16 years who presented to hospital with a traumatic injury in Ontario, Canada. Statistical analysis was conducted from October 2023 to October 2025. Exposure:Implementation of the 2015 update to the FTT guidelines as specified in version 2.1 of the Ontario Basic Life Support Patient Care Standards. The exposure was divided into 3 timeframes: pre-FTT (April 1, 2009, to June 30, 2014), implementation (July 1, 2014, to May 2 31, 2015), and postimplementation (June 1, 2015, to March 31, 2020). Main Outcomes and Measures:Patients were categorized as undertriaged, overtriaged, or appropriately triaged based on hospital of presentation and presence of a severe injury (defined as Injury Severity Score [ISS] ≥16 or death within 24 hours of injury). Interrupted time series analysis was used to estimate temporal trends in triage rates and variations in these rates associated with the updated FTT guidelines, adjusting for differences in sociodemographic and injury characteristics. Results:Of 281 268 patients with traumatic injury (mean [SD] age, 62.4 [22.5] years; 141 450 [50.3%] female; median [IQR] ISS, 4 [4-9]) included, 53 870 (19.2%) presented directly to a trauma center. Among patients who presented to a trauma center, 28 494 (52.9%) had a minor injury. Population-level rates of undertriage and overtriage were 63.5% and 12.3%, respectively. At the population level, the implementation of updated FTT guidelines was associated with a 15.2% instantaneous decrease in undertriage (rate ratio [RR], 0.85; 95% CI, 0.77-0.94). Conversely, there was no instantaneous change in overtriage (RR, 0.90; 95% CI, 0.79-1.04). During the 5 years after implementation, rates of undertriage increased by 2.4% per year (RR, 1.02; 95% CI, 1.02-1.03) while overtriage decreased by 3.8% annually (RR, 0.96; 95% CI, 0.95-0.97). Across trauma centers, the updated FTT guidelines were associated with a 14.4% instantaneous decrease in the proportion of patients with minor injuries presenting to a trauma center (RR, 0.86; 95% CI, 0.77-0.95). During 5 years after implementation, the rate at which patients with minor injuries presented directly to a trauma center remained constant (RR, 1.00; 95% CI, 0.99-1.01). Conclusion and Relevance:In this cohort study, the implementation of updated FTT guidelines was immediately associated with a 15% decrease in undertriage without an increase in overtriage. After the implementation of these guidelines, rates of undertriage increased by 2% each year. These findings suggest that FTT is effective in decreasing undertriage; however, ongoing monitoring is required to ensure that these benefits are maintained.

Timely surgical intervention is often critical in managing acute traumatic brain injury (TBI). Artificial intelligence (AI) may support triage by predicting neurosurgical need, especially where specialist expertise is lacking. While multimodal models that combine imaging and clinical data are often thought to improve performance, they also increase data acquisition complexity. This study evaluated whether multimodal AI models outperform unimodal models in predicting neurosurgical intervention for TBI. 3442 total patients presenting with a TBI were used in this research. Patients were split into two distinct datasets, a development dataset, and a holdout test dataset. The development dataset consisted of 2,928 adult trauma patients with CT and clinical data and was used to develop three models: clinical-only, imaging-only, and combined. Performance was assessed on the holdout test dataset of 514 patients. The clinical model achieved an AUC of 0.68 [0.64–0.73], the imaging model 0.86 [0.82–0.89], and the combined multimodal model 0.89 [0.86–0.92]. The combined model did not significantly outperform the image-only model. Given minimal gain and added complexity, image-based AI may offer a simpler, equally effective triage solution for TBI.

Background Trauma remains one of the leading causes of death and disability in the USA, yet trauma research continues to suffer from inconsistent data collection standards, hindering data aggregation and interoperability. To advance trauma science and improve patient outcomes, the Department of Defense, in collaboration with the Coalition for National Trauma Research (CNTR), aimed to identify and implement a core set of common data elements (CDEs) for universal use in trauma research. Methods A consensus-driven methodology guided by ACCORD reporting standards was employed. CNTR established a CDE Steering Committee comprising military, civilian, and academic trauma experts. Existing trauma and traumatic brain injury CDEs from the National Trauma Research Repository (NTRR) and the Federal Interagency Traumatic Brain Injury Research Informatics System were systematically compared, harmonized, and refined using informatics tools and expert feedback. The CDE Steering Committee met to evaluate 50 candidate data elements, with consensus defined as ≥80% agreement a priori. Results Nineteen committee members (9 in person, 10 virtually) participated in the survey. A final set of 10 core trauma CDEs was approved for inclusion in NTRR v2, categorized under demographics and injury characteristics. An additional 22 elements were referred to domain-specific workgroups for consideration in future basic CDE development. This process marks a critical step in improving trauma data harmonization. Discussion The adoption of these core trauma CDEs will support harmonization across trauma studies, enabling data reuse, pooled analysis, and cost-efficient trauma research. While consensus-based, this approach allows flexibility across study types but does not guarantee data harmonization. Successful implementation hinges on endorsement from funders and institutions. Future work includes developing therapeutic area-specific basic CDEs and promoting CDE adoption through training, technical support, and dissemination strategies. Level of evidence Not applicable (methods-focused study).

Timely hemorrhage control is a critical determinant of survival after traumatic injury. Advances in endovascular techniques have expanded the role of interventional radiology, making it an essential component of contemporary trauma care. This position statement affirms the importance of rapid hemorrhage control, emphasizes the role of interventional radiologists as integral members of multidisciplinary trauma teams, and clarifies expectations related to the American College of Surgeons Verification, Review, and Consultation (VRC) Program standards for interventional radiology resources and availability. It also provides guidance for trauma centers to optimize institutional processes and coordination between trauma surgery and interventional radiology to ensure timely and effective hemorrhage control for injured patients.

Objective: To evaluate the impact of trauma center care on one-year mortality among injured older adults. Background: Older adults represent the fastest growing population of injured patients, however the long-term benefit of trauma center care among these patients is unknown. Methods: We performed a population-based cohort study of individuals age ≥ 65 with moderate or severe injuries (presence of an American College of Surgeons defined critical injury, Injury Severity Score [ISS] ≥ 9, or death within 24hrs) who presented to a hospital in Ontario, Canada between 2009-2020. Patients with isolated hip fractures were excluded. Differential distance between the nearest trauma and non-trauma centers was used in an adjusted instrumental variable analysis to estimate the impact of trauma center care on mortality. Stratified analyses were performed to evaluate the effect of age, injury severity, and isolated severe head injuries on the relationship between trauma center care and one-year outcomes. Results: Among 55,799 injured older adults, 15,857 (28.4%) were treated at a trauma center. The overall one-year mortality was 27.4% (n=15,285). Adjusted analysis demonstrated that trauma center care was associated with a 3.5% (95% CI: 1.2-5.8%) absolute decrease in one-year mortality. The beneficial effect of trauma center care was consistent across age groups and both moderate and severe injuries. However, patients with isolated brain injuries appeared to derive no benefit from trauma center care (one-year mortality difference -1.3% [95% CI -4.1-1.5%]). Conclusion and Relevance: Among older adults with moderate or severe injuries, trauma center care was associated with reduced one-year mortality. These findings highlight the importance of trauma center care among older adults and suggest that a lower threshold for transfer of these patients may be beneficial.

BACKGROUND:Early and adequate analgesia is a critical component of injury care. While sociodemographic factors have been shown to impact the adequacy of analgesia in a variety of clinical settings, these relationships are poorly understood in trauma care. Our objective was to evaluate the association between patient and provider characteristics and time to analgesia during trauma resuscitation. METHODS:We performed a retrospective cohort study of adult (age ≥ 16) patients presenting as trauma activations at a level I trauma center over 2 years (2019-2020). Data were derived from the institutional trauma registry and chart review. Time from presentation to first administration of analgesia was recorded. The primary outcome was delayed analgesia, defined as analgesia administered later than the 75th percentile of time to analgesia for all patients. Multivariable logistic regression was used to evaluate the effect of age, sex, and socioeconomic status on analgesia timing. RESULTS:Among 2497 patients meeting inclusion criteria (mean age 44.8 years [SD 21.6], 25.7% female), 1957 (77.5%) received analgesia in the trauma bay. Among patients who received analgesia in the trauma bay, median time to analgesia was 9 min (IQR 7-14). The only sociodemographic characteristic independently associated with delayed analgesia was age. Relative to patients aged 16-54, those aged 55-64 were 1.5-fold more likely to receive delayed analgesia (OR 1.46; 95% CI 1.05-2.03), while those aged ≥ 65 were twice as likely to have delayed analgesia (OR 2.16; 95% CI 1.58-2.95). Irrespective of age or injury severity, patients injured in falls were more likely to experience delayed analgesia (OR 1.64; 95% CI 1.20-2.23). CONCLUSION:Older adults and patients injured in a fall are more likely to experience delays in receiving analgesia. Strategies that ensure equity in pain management are needed such that all patients have equitable access to early and adequate pain control after injury.

BACKGROUND CONTEXT:Optimal timing of pharmacologic thromboprophylaxis in patients with acute traumatic spinal cord injury (SCI) is unclear. Most guideline recommendations are consensus-based and lacking in primary large-scale data. This study evaluated an ideal timeframe for delivery of thromboprophylaxis in acute SCI. PURPOSE:Determine the ideal timeframe for initiation of chemical thromboprophylaxis in the setting of acute SCI. STUDY DESIGN/SETTING:Retrospective cohort study. North American trauma centers participating in the American College of Surgeons Trauma Quality Improvement Program (2017-2022). PATIENT SAMPLE:Adults (≥16 years) with acute SCI secondary to blunt trauma who underwent surgical decompression within 24 hours. OUTCOME MEASURES:Primary: in-hospital venous thromboembolism. Secondary: in-hospital return to the operating room, death during admission and length of stay. METHODS:Restricted cubic splines identified an inflection point defining early versus late thromboprophylaxis initiation, which was used for propensity score-matched comparisons. Covariates for propensity matching included patient, injury, treatment, and hospital characteristics. Effect size was calculated using risk difference (RDs) and odds ratio (OR) for dichotomous outcomes and mean difference (MD) for linear outcomes with associated 95% confidence interval (CI). RESULTS:Total of 15,960 patients across 511 trauma centers were included. Spline analysis indicated increasing risk after 24-48 hours from surgery. In propensity-matched cohorts for postoperative day 1 (ie, early <48 hours; late ≥48 hours) (N=6,867 per group), early thromboprophylaxis was associated with lower VTE rates (4.7% vs 5.9%; p=.002; OR 1.26 [95% CI: 1.09, 1.46]), fewer returns to operating room overall (2.2% vs 2.9%; p=.004; OR 1.38 [95% CI 1.11, 1.71]), no difference in return to operating room for same-level spine procedure (0.7% vs 1.0%; p=.07; OR 1.4 [95% CI 0.98, 2.02]), lower mortality (4.0% vs 4.9%; p=.003; OR 1.28 [95% CI: 1.09, 1.51]), and shorter length of stay (15.8 vs 16.9 days; p<.001; MD 1.06 days [95% CI: 0.47, 1.65]). CONCLUSIONS:Thromboprophylaxis by postoperative day 1 after was associated with a decreased risk of venous thromboembolism, decreased returns to the operating room, no increased return to the operating room for related spine procedure, decreased risk of death, and decreased length of stay. Administration of thromboprophylaxis by postoperative day 1 for acute SCI patients may represent a new clinical standard for optimal patient outcomes.

Objective:To determine whether ratings are associated with postoperative outcomes. Background:Online ratings by patients or inclusion on lists of exceptional physicians are publicly available. Methods:In this retrospective study, Medicare fee-for-service beneficiaries 65 to 99 years old undergoing one of 14 major (elective/emergent) surgeries in the United States between 2016 and 2019 were analyzed. Data were analyzed from September 2023 to March 2024. Using computational methods to extract surgeon ratings from the three highest-volume publicly available patient-initiated and peer-nominated rating platforms. The exposure of interest was ratings (0-4, 4-4.49, ≥ 4.5) on patient-initiated platforms and "Top Doctor" status on the peer-nominated platform. The primary outcome was 30-day mortality. Secondary outcomes included 30-day complications, readmission, failure to rescue, and hospital length of stay. Using linear probability models, we controlled for patient, surgeon, and hospital factors to examine associations between ratings and outcomes. Results:We identified 2,690,315 patients operated on by 57,008 surgeons. Patient-initiated ratings were not consistently associated with 30-day mortality but were significantly associated with lower mortality among those treated by surgeons rated 4 to 4.49 on Platform B [adjusted risk difference (ARD), -0.06 % (95% confidence interval (CI) = -0.11 to -0.01)]. Patients treated by "Top Doctor" surgeons through peer-nomination had lower 30-day mortality ARD, -0.14 % (95% CI = -0.19 to -0.09). Surgeons with higher patient-initiated ratings had lower rates of 30-day complications and readmissions, while "Top Doctors" experienced lower rates of failure to rescue. Conclusions:Patient-initiated and peer-nominated ratings were associated with complications and readmission; mortality and failure to rescue, respectively, suggesting they capture different aspects of surgical care.

BACKGROUND:Older adults who survive injury frequently experience functional decline, and interventions preventing this decline are needed. We therefore evaluated the association between early primary care physician (PCP) follow-up and nursing home admission or death among injured older adults. METHODS:We performed a retrospective, population-based cohort study of community-dwelling older adults (65 years or older) discharged alive after injury-related hospitalization (2009-2020). The exposure of interest was early PCP visit (within 14 days of discharge). The primary outcome was time to death or nursing home admission in the year after discharge. Cox proportional hazards models were used to evaluate the relationship between early PCP visit and this outcome, adjusting for baseline characteristics. RESULTS:Among 93,482 patients (63.7% female; mean age, 79.8 years), 24,167 (25.9%) had early follow-up with their own PCP and 6,083 (6.5%) with a different PCP. In the year after discharge, 16,676 patients (17.8%) died or were admitted to a nursing home. After risk adjustment, early follow-up with one's own PCP was associated with a 15% reduction in the hazard of death or nursing home admission relative to no follow-up (hazard ratio, 0.85; 95% confidence interval, 0.83-0.87). Follow-up with a different PCP was not associated with the outcome (hazard ratio, 0.99; 95% confidence interval, 0.95-1.03). These relationships were consistent across all age, sex, frailty, and injury severity strata. CONCLUSION:Among injured older adults, early follow-up with their own PCP was associated with increased time alive and at home. These findings suggest strategies to integrate PCPs into postinjury care of older adults should be explored. LEVEL OF EVIDENCE:Therapeutic/Care Management; Level IV.

BACKGROUND AND OBJECTIVES:Tracheostomy is crucial for managing airway and respiratory complications in spinal cord injury (SCI) patients, with recent studies linking its timing to respiratory outcomes. The aim of this study was to determine the association between adverse events and tracheostomy timing in complete traumatic cervical SCI patients. METHODS:This multicenter retrospective observational cohort study used data from the Trauma Quality Improvement Program between 2010 and 2020 and included all complete traumatic cervical SCI patients who underwent spine surgery and tracheostomy. Tracheostomy timing was categorized into ultraearly (≤3 days), early (4-7 days), and delayed (>7 days) after surgery. The primary outcome was the occurrence of major in-hospital complications (HC). Secondary outcomes included immobility complications (IC), surgical site infections, hospital and intensive care unit (ICU) length of stay (LOS), and duration of mechanical ventilation. A secondary analysis directly compared the ultraearly and early tracheostomy groups. RESULTS:Among 2907 patients analyzed, 307 (10.6%) underwent ultraearly, 1034 (35.5%) early, and 1566 (53.9%) delayed tracheostomy. Adjusted multivariable analyses revealed significant reductions in HC and IC by 33% to 47% and 28% to 32%, respectively, for the ultraearly and early tracheostomy groups compared with the delayed group. In addition, both ultraearly and early groups experienced similar shorter hospital and ICU stays, and shorter ventilation durations compared with the delayed group. Secondary analysis with a direct comparison between the ultraearly and early groups showed a significant reduction of 3 days in ICU LOS in the ultraearly group. However, there were no significant differences in HC, IC, surgical site infections, hospital LOS, or ventilation duration between the ultraearly and early groups. CONCLUSION:Our findings indicate that ultraearly and early tracheostomy provide comparable benefits with delayed tracheostomy. If confirmed in prospective studies, this flexibility in tracheostomy timing would allow more thorough patient assessments, ensuing goal-concordant care and making informed decisions without compromising the advantages of early intervention.

INTRODUCTION:In moderate to high-risk surgical procedures, 15-25% of patients develop a postoperative surgical site infection. Intraoperative incisional wound irrigation has the potential to reduce surgical site infections, and additional randomised controlled trials are required to provide evidence of effectiveness. METHODS AND ANALYSIS:This protocol describes a pragmatic, adaptive, participant and adjudicator-blinded trial at 13 sites in Canada in up to 2500 participants. Participants planned for surgery with an abdominal or groin incision, who are eligible and provide verbal consent through an integrated consent model, are randomised to receive intraoperative incisional wound irrigation with povidone-iodine, saline or no irrigation. The primary outcome is surgical site infection within 30 days postoperatively. Secondary outcomes include quality of life measured 30 days postoperatively and morbidity, mortality and healthcare utilisation within 90 days postoperatively. ETHICS AND DISSEMINATION:This trial has been approved by the research ethics board at the participating centres and stopped enrolling participants on May 23, 2025. All participants will provide verbal consent. Results will be disseminated via presentation at conferences, publication and posted on clinicaltrials.gov. TRIAL REGISTRATION NUMBER:The study is registered with http://clinicaltrial.gov (NCT04548661; 14 September 2020).

Importance:Patients with bleeding and coagulopathic trauma often require more transfusions and have higher mortality rates, motivating research on improving hemostatic strategies. Objective:To evaluate the replacement of clotting factors with frozen plasma (FP) or factor concentrates (fibrinogen concentrate [FC] and prothrombin complex concentrate [PCC]) in the initial resuscitation of patients with trauma. Design, Setting, and Participants:This multicenter, parallel-control, superiority randomized clinical trial was conducted at 6 level I trauma centers in Canada, between April 2021 and February 2023. Eligible patients were those with massive hemorrhage protocol (MHP) activation on admission and aged 16 years or older. Patients were excluded if they received more than 2 red blood cell (RBC) units either before hospital admission or in the hospital prior to randomization or if they had a catastrophic head injury. Follow-up was completed on March 25, 2023. The primary analysis was based on the modified intention-to-treat approach. Interventions:The intervention group received FC 4 g and PCC 2000 IU in MHP packs 1 and 2. The control group received 4 FP units. Concurrently, patients received 4 RBC units (both packs) and 1 dose of platelets (pack 2). After pack 2, FP was administered at clinician discretion. Main Outcomes and Measures:Primary outcome was the number of allogeneic blood product (RBC, FP, and platelet) units administered within 24 hours. Secondary outcomes included incidence of thromboembolic events, duration of intensive care unit stay, and mortality. Results:Of the 217 patients enrolled, 107 were randomly assigned to the FC-PCC group and 110 to the FP group; 137 patients were included in the primary analysis (66 in the FC-PCC group and 71 in the FP group). Baseline characteristics were similar between groups (median [IQR] age, 38 [29-55] years; 111 males [81.0%]). Among these patients, 95 (69.3%) had blunt mechanisms of injury, and the median (IQR) Injury Severity Score was 29 (19-43). Mean 24-hour transfusions were 20.8 (95% CI, 16.7-25.9) units in the FC-PCC group and 23.8 (95% CI, 19.2-29.4) units in the FP group. The mean ratio was 0.87 (1-sided 97.5% CI, 0.00-1.19; P = .20 for superiority). No significant differences were found in thromboembolic complications or 24-hour and 28-day mortality. The trial was terminated after the interim analysis showed conditional power of less than 25%, requiring an impractically large sample to show superiority. Conclusions and Relevance:In this randomized clinical trial, clotting factor concentrates were not superior to FP for initial resuscitation of patients with trauma. Efficacy and safety outcomes were similar across the treatment groups. Trial Registration:ClinicalTrials.gov Identifier: NCT04534751.