Effect of rFVIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn

Study Overview
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Brief Summary
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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.

Detailed Description
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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, determine if fFVIIa should be used to reduce peri-operative blood loss in patients undergoing excision greater than or equal to 20 percent of the total body surface area, determine the efficacy of the drug in burned patients undergoing excision of burn wounds.

Official Title
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Effect of Recombinant Coagulation Factor VIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn Excision and Grafting

Conditions
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Burns

Intervention / Treatment
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* Drug: Recombinant Factor VIIa
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rFVIIa<br>intravenous administration of rFVIIa (Novoseven; 90 micrograms/kg, IV push, given at start of first surgical incision and again at 1 hr after start of surgery) | Drug: Recombinant Factor VIIa<br>* intravenous infusion of Factor VIIa<br>|
| Placebo Comparator: Control<br>intravenous administration of placebo (sterile water, IV push, given at first surgical incision and again at 1 hr after start of surgery) | Drug: Placebo<br>* intravenous infusion of placebo (sterile water)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burns