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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00243243
First Posted: October 21, 2005
Last Update Posted: May 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
United States Army Institute of Surgical Research
October 19, 2005
October 21, 2005
August 28, 2012
March 6, 2013
May 26, 2016
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 ]
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
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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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Burns
  • Drug: Recombinant Factor VIIa
    intravenous infusion of Factor VIIa
  • Drug: Placebo
    intravenous infusion of placebo (sterile water)
  • Experimental: rFVIIa
    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)
    Intervention: Drug: Recombinant Factor VIIa
  • Placebo Comparator: Control
    intravenous administration of placebo (sterile water, IV push, given at first surgical incision and again at 1 hr after start of surgery)
    Intervention: Drug: 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.

*   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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00243243
H-05-027
No
Not Provided
Plan to Share IPD: 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
April 2016

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