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

This study is currently recruiting participants.

Verified by United States Army Institute of Surgical Research, January 2009

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 stop 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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), 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 Outcome Measures:

Reduce peri-operative blood loss and transfusion requirements [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	52
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Recombinant Factor VIIa intravenous infusion of Factor VIIa

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243243

Contacts

Contact: Chaya Galin, RN	210-916-7154	chaya.galin@amedd.army.mil
Contact: Michelle Morrow, RN	210-916-8147	michelle.morrow@amedd.army.mil

Locations

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

Sponsors and Collaborators

United States Army Institute of Surgical Research

Investigators

Principal Investigator:

Myung S Park, MD

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.

Responsible Party:	USAISR ( Myung Park, LTC, MC )
Study ID Numbers:	H-05-027
Study First Received:	October 19, 2005
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00243243
Health Authority:	United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:

Burns

Study placed in the following topic categories:

Burns
Wounds and Injuries
Disorders of Environmental Origin
Hemorrhage

ClinicalTrials.gov processed this record on February 05, 2009