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


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Antihemophilic Factor (Human or Recombinant)

Advate; AHF (Human); AHG; Alphanate; Factor VIII; Hemofil M; Humate-P; Koate DVI; Koate-HP; Kogenate FS; Monarc-M; Monoclate-P; Profilate HP; ReFacto



Clinical Trial: Effect of rFVIIa on Peri-Operative Blood Loss in Patients Undergoing Major Burn

This study is not yet open for patient recruitment.
Verified by United States Army Institute of Surgical Research October 2005

Sponsored by: United States Army Institute of Surgical Research
Information provided by: United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier: NCT00243243

Purpose

The purpose of the study is to see if a medication (Recombinant Coagulation Factor VIIa or NovoSeven), normally used to stip bleeding in persons with a bleeding disorder, will lower the amount of blood lost during burn surgery.
Condition Intervention Phase
Burns
  Drug: Recombinant Factor VIIa
 Phase III

MedlinePlus related topics:  Burns

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by United States Army Institute of Surgical Research:
Primary Outcomes: Reduce peri-operative blood loss and transfusion requirements
Expected Total Enrollment:  52

Study start: November 2005;  Expected completion: December 2006
Last follow-up: December 2006;  Data entry closure: December 2006

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.

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

Male or female burn wounds 18-65 years of age scheduled 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 previously enrollment in this study -

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00243243

Nancy C Molter, RN, PhD      210-916-5690    Nancy.Molter@amedd.army.mil
Elizabeth A Frail, RN, BSN      210-916-8192    Elizabeth.Frail@amedd.army.mil

Texas
      United States Army Institute of Surgical Research, Ft. Sam Houston,  Texas,  78234,  United States
Annette R McClinton, RN, MA  210-916-2834    Annette.McClinton@amedd.army.mil 
Nancy C Molter, RN, PhD  210-916-5690    Nancy.Molter@amedd.army.mil 

Study chairs or principal investigators

Myung S Park, MD,  Principal Investigator,  United States Army Institute of Surgical Research   

More Information

Publications

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.

Study ID Numbers:  H-05-027
Last Updated:  December 8, 2005
Record first received:  October 19, 2005
ClinicalTrials.gov Identifier:  NCT00243243
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10


Source: ClinicalTrials.gov
Cache Date: January 11, 2006

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December 3, 2008


Page Updated: June 1, 2005
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