At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 20 enrolled
Drug / intervention
Recombinant Factor VIIa +1 moredrug
Likely dose
Intravenous infusion of recombinant Factor VIIa (specific dose not stated in trial record)AI-extracted
Key inclusion· 3
- ✓Age 18–65 years
- ✓Burn wounds requiring scheduled excision
- ✓Burn wound excision of at least 20% TBSA (total body surface area)
Key exclusion· 10
- ✕Age greater than 65 years
- ✕History of blood coagulation disorders
- ✕Currently taking anticoagulation medication
- ✕Contraindication for heparin therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Recombinant Coagulation Factor VIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn Excision and Grafting
United States Army Institute of Surgical Research·interventional·Posted Oct 21, 2005·Updated May 26, 2016
In Brief
A Phase 3 clinical trial evaluating Recombinant Factor VIIa and Placebo for Burns. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The purpose of the study is to see if a medication (Recombinant Coagulation Factor VIIa or NovoSeven), normally used to stop bleeding in persons with a bleeding disorder, will lower the amount of blood lost during burn surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBurns
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2005
Enrollment StartJan 2006
Primary CompletionJun 2011
Study CompletionJul 2011
TodayJul 2026
First PostedOct 21, 2005
Enrollment StartJan 1, 2006
Primary CompletionJun 1, 2011
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 20.7 years ago
Interventions
Recombinant Factor VIIadrug
intravenous infusion of Factor VIIa
Placebodrug
intravenous infusion of placebo (sterile water)