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NCT00323570 Clinical Trial

Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Due to Trauma

Trauma Clinical Trial

Official title:
A Multi-center, Randomized, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®/ NiaStase®) in the Treatment of Refractory Bleeding in Severely Injured Trauma Patients

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00323570
Other study ID # F7TRAUMA-1648
Secondary ID
Status Withdrawn
Phase Phase 3
First received May 8, 2006
Last updated June 26, 2012
Start date May 2006
Est. completion date June 2007

Study information
Verified date March 2012
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This trial is conducted in the United States of America (USA). The purpose of this study is to evaluate the treatment of Recombinant Faction VIIa in Patients with Severe Bleeding Due to Trauma

Please note that this trial and trial F7TRAUMA-1711 (NCT00184548) have been merged.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Trauma injury (blunt and/or penetrating) with evidence of active torso hemorrhage refectory to standard treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• activated recombinant human factor VII

Locations
Country Name City State
United States Novo Nordisk Clinical Trial Call Center Akron Ohio
United States Novo Nordisk Clinical Trial Call Center Allentown Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Baltimore Maryland
United States Novo Nordisk Clinical Trial Call Center Boston Massachusetts
United States Novo Nordisk Clinical Trial Call Center Bronx New York
United States Novo Nordisk Clinical Trial Call Center Brooklyn New York
United States Novo Nordisk Clinical Trial Call Center Camden New Jersey
United States Novo Nordisk Clinical Trial Call Center Chicago Illinois
United States Novo Nordisk Clinical Trial Call Center Cleveland Ohio
United States Novo Nordisk Clinical Trial Call Center Colorado Springs Colorado
United States Novo Nordisk Clinical Trial Call Center Columbus Ohio
United States Novo Nordisk Clinical Trial Call Center Detroit Michigan
United States Novo Nordisk Clinical Trial Call Center Fort Sam Houston Texas
United States Novo Nordisk Clinical Trial Call Center Gainesville Florida
United States Novo Nordisk Clinical Trial Call Center Greenville North Carolina
United States Novo Nordisk Clinical Trial Call Center Indianapolis Indiana
United States Novo Nordisk Clinical Trial Call Center Jacksonville Florida
United States Novo Nordisk Clinical Trial Call Center Lackland AFB Texas
United States Novo Nordisk Clinical Trial Call Center Las Vegas Nevada
United States Novo Nordisk Clinical Trial Call Center Los Angeles California
United States Novo Nordisk Clinical Trial Call Center Louisville Kentucky
United States Novo Nordisk Clinical Trial Call Center Madison Wisconsin
United States Novo Nordisk Clinical Trial Call Center Maywood Illinois
United States Novo Nordisk Clinical Trial Call Center Memphis Tennessee
United States Novo Nordisk Clinical Trial Call Center Miami Florida
United States Novo Nordisk Clinical Trial Call Center Nashville Tennessee
United States Novo Nordisk Clinical Trial Call Center Oklahoma City Oklahoma
United States Novo Nordisk Clinical Trial Call Center Philadelphia Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Philadelphia Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Philadelphia Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Phoenix Arizona
United States Novo Nordisk Clinical Trial Call Center Pittsburgh Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Portland Oregon
United States Novo Nordisk Clinical Trial Call Center Portland Maine
United States Novo Nordisk Clinical Trial Call Center Providence Rhode Island
United States Novo Nordisk Clinical Trial Call Center Sacramento California
United States Novo Nordisk Clinical Trial Call Center Salt Lake City Utah
United States Novo Nordisk Clinical Trial Call Center San Antonio Texas
United States Novo Nordisk Clinical Trial Call Center Springfield Missouri
United States Novo Nordisk Clinical Trial Call Center St. Louis Missouri
United States Novo Nordisk Clinical Trial Call Center Washington District of Columbia
United States Novo Nordisk Clinical Trial Call Center Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality and Morbidity through day 30 No
Secondary All cause mortality No
Secondary Hospital-free days No
Secondary Number of transfusion units No
Secondary Days free of renal replacement therapy No
Secondary ICU-free days No
Secondary Days free of ventilator support No
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