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

Phase 3

Completed

• Conditions: Burns
• Interventions: Drug: Placebo; Drug: Recombinant Factor VIIa

• Registration Number: NCT00243243
• Lead Sponsor: United States Army Institute of Surgical Research

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 blood lost during burn surgery.

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, 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.

Study Timeline

• Study First Submitted: 2005-10-19
• Study First Submitted QC: 2005-10-19
• Study First Posted: 2005-10-21
• Study Start: 2006-01
• Primary Completion: 2011-06
• Study Completion: 2011-07
• Results First Submitted: 2012-08-28
• Results First Submitted QC: 2013-01-29
• Results First Posted: 2013-03-06
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-26
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	intravenous administration of placebo (sterile water, IV push, given at first surgical incision and again at 1 hr after start of surgery)
rFVIIa	Recombinant Factor VIIa	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)

Primary Outcome Measures

Name	Time	Method
Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively	24 hours

Trial Locations

Locations (1)

United States Army Institute of Surgical Research; 🇺🇸 Ft Sam Houston, Texas, United States