Database analysis of completed clinical trials investigating hemostatic agents: implications for military trauma care

Abstract

Annotation. This database analysis examined 365 completed clinical trials investigating hemostatic agents retrieved from ClinicalTrials.gov to characterize evidence for military trauma applications. Investigation revealed substantial clinical research activity with 183 studies addressing bleeding control and 148 studies involving surgical applications. Tranexamic acid emerged as the most extensively studied intervention with 49 trials encompassing 10,526 participants, followed by topical hemostatic matrices including TachoSil (11 studies, 5,095 participants), Floseal (13 studies, 1,845 participants), and Surgicel (12 studies, 1,400 participants). Topical matrices and sealants (58 studies, 15.9%) were identified as the predominant category, followed by antifibrinolytic agents (50 studies, 13.7%). Geographic distribution demonstrated United States leadership with 110 studies (30.1%) across 47 participating countries. Critical assessment revealed only one study conducted in military settings. This represents a fundamental disconnection between civilian clinical validation and battlefield operational requirements. The absence of battlefield-validated protocols and austere environment testing constitutes critical limitations in evidence translation to combat casualty care. Future research priorities must emphasize studies conducted under combat-relevant conditions to bridge the civilian-military evidence gap.