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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00243243
• Other study ID #: H-05-027
• Status: Completed
• Phase: Phase 3
• First received: October 19, 2005
• Last updated: March 28, 2013
• Start date: January 2006
• Est. completion date: July 2011

Study information

• Verified date: March 2013
• Source: United States Army Institute of Surgical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Drug:
• Recombinant Factor VIIa
intravenous infusion of Factor VIIa

Locations

Country	Name	City	State
United States	United States Army Institute of Surgical Research	Ft Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
United States Army Institute of Surgical Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

Deveras RA, Kessler CM. Reversal of warfarin-induced excessive anticoagulation with recombinant human factor VIIa concentrate. Ann Intern Med. 2002 Dec 3;137(11):884-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively		24 hours	No