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

NCT00243243 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-05-26

Study results available
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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.

Conditions

  • Burns

Interventions

DRUG

Recombinant Factor VIIa

intravenous infusion of Factor VIIa

DRUG

Placebo

intravenous infusion of placebo (sterile water)

Sponsors & Collaborators

  • United States Army Institute of Surgical Research

    lead FED

Principal Investigators

  • Myung S Park, MD · United States Army Institute of Surgical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2011-06-30
Completion
2011-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00243243 on ClinicalTrials.gov