Status:
COMPLETED
Effect of rFVIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn
Lead Sponsor:
United States Army Institute of Surgical Research
Conditions:
Burns
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 bloo...
Detailed Description
To identify the clinical use for Factor VIIa in the operating room to reduce blood loss and blood transfusion , determine the Recombinant Factor VIIa (rFVIIa) pharmacokinetics in burned patients, dete...
Eligibility Criteria
Inclusion
- Male or female
- Burn wounds
- 18-65 years of age
- Scheduled excision of burn wound of at least 20 percent TBSA
Exclusion
- Age greater than 65 years
- History of blood coagulation disorders
- Taking anti-coagulation medication
- Contraindication for heparin therapy
- Pregnant or nursing females
- Unstable angina
- MI within the last 6 months
- Recent of diagnosis of DVT, stroke within the last 6 months
- Renal failure requiring dialysis or creatinine clearance less than 25 ml/min
- Religious prohibition to blood transfusion
- Have received rFVIIa during current hospitalization
- Previous enrollment in this study
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00243243
Start Date
January 1 2006
End Date
July 1 2011
Last Update
May 26 2016
Active Locations (1)
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1
United States Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234