drugset / Trial / NCT00048646
Progesterone Treatment of Blunt Traumatic Brain Injury
Phase 1/2
Completed
100 enrolled
David Wright
National Institute of Neurological Disorders and Stroke (NINDS) · collab
RandomizedSingle-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine if progesterone treatment safely reduces brain swelling and damage after injury.
Timeline
- Start
- 2002-05
- Primary completion
- 2005-09
- Completion
- 2005-09
Publications
- Background Wright DW, Clark PL, Pentz RD, Hertzberg V, Kellermann AL. Enrolling subjects by exception from consent versus proxy consent in trauma care research. Ann Emerg Med. 2008 Apr;51(4):355-60, 360.e1-3. doi: 10.1016/j.annemergmed.2007.08.021. Epub 2007 Oct 15.
- Results Wright DW, Kellermann AL, Hertzberg VS, Clark PL, Frankel M, Goldstein FC, Salomone JP, Dent LL, Harris OA, Ander DS, Lowery DW, Patel MM, Denson DD, Gordon AB, Wald MM, Gupta S, Hoffman SW, Stein DG. ProTECT: a randomized clinical trial of progesterone for acute traumatic brain injury. Ann Emerg Med. 2007 Apr;49(4):391-402, 402.e1-2. doi: 10.1016/j.annemergmed.2006.07.932. Epub 2006 Sep 29.
- Results Wright DW, Ritchie JC, Mullins RE, Kellermann AL, Denson DD. Steady-state serum concentrations of progesterone following continuous intravenous infusion in patients with acute moderate to severe traumatic brain injury. J Clin Pharmacol. 2005 Jun;45(6):640-8. doi: 10.1177/0091270005276201.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Progesterone | Other / unclassified | 0.5 mg/kg | Intravenous |