Phase 3
Completed N=20
Effect of rFVIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn
Burns
Source: ClinicalTrials.gov NCT00243243 ↗
Enrolled (actual)
20
Serious AEs
60.0%
Results posted
Mar 2013
Primary outcomePrimary: Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively — 68.9; 87.2; 0; 4.1 units of blood components
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively |
68.9; 87.2; 0; 4.1; 1.02; 6.45 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female
- Burn wounds
- 18-65 years of age
- Scheduled excision of burn wound of at least 20 percent TBSA
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00243243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.