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
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2006
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2005
CompletedFirst Posted
Study publicly available on registry
October 21, 2005
CompletedStudy Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
March 6, 2013
CompletedMay 26, 2016
April 1, 2016
5.4 years
October 19, 2005
August 28, 2012
April 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively
24 hours
Study Arms (2)
rFVIIa
EXPERIMENTALintravenous 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)
Control
PLACEBO COMPARATORintravenous administration of placebo (sterile water, IV push, given at first surgical incision and again at 1 hr after start of surgery)
Interventions
Eligibility Criteria
You may qualify if:
- Male or female
- Burn wounds
- years of age
- Scheduled excision of burn wound of at least 20 percent TBSA
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
United States Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234, United States
Related 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. doi: 10.7326/0003-4819-137-11-200212030-00009.
PMID: 12458988BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- David G. Baer, PhD, Director Research
- Organization
- US Army Institute of Surgical Research
Study Officials
- PRINCIPAL INVESTIGATOR
Myung S Park, MD
United States Army Institute of Surgical Research
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2005
First Posted
October 21, 2005
Study Start
January 1, 2006
Primary Completion
June 1, 2011
Study Completion
July 1, 2011
Last Updated
May 26, 2016
Results First Posted
March 6, 2013
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share