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

2017; Lippincott Williams & Wilkins; Volume: 47; Issue: 5 Linguagem: Inglês

10.1097/shk.0000000000000788

1540-0514

Erin E. Fox, John B. Holcomb, Charles E. Wade, Eileen M. Bulger, Barbara C. Tilley,

Abdominal Trauma and Injuries

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.