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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT00243243
First received: October 19, 2005
Last updated: March 28, 2013
Last verified: March 2013
History of Changes

October 19, 2005
March 28, 2013
January 2006
June 2011   (final data collection date for primary outcome measure)
Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Reduce peri-operative blood loss and transfusion requirements
Complete list of historical versions of study NCT00243243 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of rFVIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn
Effect of Recombinant Coagulation Factor VIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn Excision and Grafting

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Burns
Drug: Recombinant Factor VIIa
intravenous infusion of Factor VIIa
  • Experimental: rFVIIa
    intravenous administration of rFVIIa
    Intervention: Drug: Recombinant Factor VIIa
  • Placebo Comparator: Control
    intravenous administration of placebo
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. Summary for patients in: Ann Intern Med. 2002 Dec 3;137(11):I41.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00243243
H-05-027
No
United States Army Institute of Surgical Research
United States Army Institute of Surgical Research
Not Provided
Principal Investigator: Myung S Park, MD United States Army Institute of Surgical Research
United States Army Institute of Surgical Research
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP