drugset / Trial / NCT00822900
Progesterone for the Treatment of Traumatic Brain Injury III
Phase 3
Terminated
882 enrolled
David Wright
Medical University of South Carolina · collabNeurological Emergencies Treatment Trials Network (NETT) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The ProTECT study will determine if intravenous (IV) progesterone (started within 4 hours of injury and given for a total of 96 hours), is more effective than placebo for treating victims of moderate to severe acute traumatic brain injury.
Timeline
- Start
- 2010-03
- Primary completion
- 2014-05
- Completion
- 2014-07
Outcome
Missed primary endpoint
Stopped: “futility: low conditional power to demonstrate benefit of progesterone”
registry analysis (superiority or other test); Progesterone vs Placebo; p = 0.35; Risk Ratio (RR) 0.95 (95% CI 0.85 to 1.06) NCT00822900 ↗
paper There was no significant difference between the progesterone group and the placebo group in the proportion of patients with a favorable outcome PMID 25493974 ↗
Publications
- Zhao W, Pauls K. Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system. Clin Trials. 2016 Apr;13(2):223-33. doi: 10.1177/1740774515611889. Epub 2015 Oct 13.
- Wright DW, Yeatts SD, Silbergleit R, Palesch YY, Hertzberg VS, Frankel M, Goldstein FC, Caveney AF, Howlett-Smith H, Bengelink EM, Manley GT, Merck LH, Janis LS, Barsan WG; NETT Investigators. Very early administration of progesterone for acute traumatic brain injury. N Engl J Med. 2014 Dec 25;371(26):2457-66. doi: 10.1056/NEJMoa1404304. Epub 2014 Dec 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Progesterone | Other / unclassified | 0.5 mg/kg | Intravenous |