Clinical outcomes of hemostatic interventions in patients with traumatic injury: A systematic review of randomized controlled trials.

Abstract

Hemorrhage is a leading cause of preventable death following trauma, and numerous randomized controlled trials (RCTs) have evaluated hemostatic interventions. However, inconsistency in outcome reporting hinders evidence synthesis and guideline development. We systematically reviewed outcomes reported in RCTs of hemostatic interventions for trauma to identify variability in outcome domains, definitions, and measurement time points. Following the PRISMA guidelines, we searched Ovid MEDLINE, EMBASE, and CENTRAL from inception to May 2025. Eligible studies were RCTs evaluating hemostatic interventions in trauma patients of any age. Two reviewers independently screened records, extracted data, and categorized outcomes into domains. Data were summarized descriptively. The review was prospectively registered with PROSPERO (ID:). Of 6,752 records screened, 110 studies were included (2005-2025). Most trials were parallel-group RCTs (88.2%), with a median sample size of 314 participants (IQR, 99-680). Tranexamic acid was the most common intervention studied (39.1%). Mortality was reported as the primary outcome in 56.4% studies, most frequently assessed at 28 to 30 days. Of all trials, 36.4% reported a statistically significant difference in the primary outcome. Patient-centered outcomes were infrequently assessed: quality of life (7.3%), functional status (2.7%), and disability (25.5%). Outcome reporting in RCTs of hemostatic interventions for trauma remains highly heterogeneous. Mortality is the most common primary endpoint, whereas patient-centered outcomes are rarely reported. Consensus on a Core Outcome Set with patient input would standardize reporting, improve comparability, and strengthen evidence for future trauma care research and policy, while also ensuring outcomes reflect patient priorities. (J Trauma Acute Care Surg. 2026;000: 000-000. Copyright © 2026 Wolters Kluwer Health, Inc. All rights reserved.). Systematic Review; Level I.