Earlier Endpoints are Required for Hemorrhagic Shock Trials Among Severely Injured Patients.

ABSTRACT:

Background

Choosing the appropriate endpoint for a trauma hemorrhage control trial can determine the likelihood of its success. Recent Phase 3 trials and observational studies have used 24-h and/or 30-day all-cause mortality as the primary endpoint and some have not used exception from informed consent (EFIC), resulting in multiple failed trials. Five recent high-quality prospective studies among 4,064 hemorrhaging trauma patients provide new evidence to support earlier primary endpoints.

Methods

The goal of this project was to determine the optimal endpoint for hemorrhage control trials using existing literature and new analyses of previously published data.

Results

Recent studies among bleeding trauma patients show that hemorrhagic deaths occur rapidly, at a high ra

SUBMITTER: Fox EE 

PROVIDER: S-EPMC5392160 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature