Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Due to Trauma
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
1 other identifier
interventional
N/A
1 country
42
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2006
Shorter than P25 for phase_3
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 8, 2006
CompletedFirst Posted
Study publicly available on registry
May 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedJune 27, 2012
March 1, 2012
1.1 years
May 8, 2006
June 26, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Mortality and Morbidity
through day 30
Secondary Outcomes (6)
All cause mortality
Hospital-free days
Number of transfusion units
Days free of renal replacement therapy
ICU-free days
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Trauma injury (blunt and/or penetrating) with evidence of active torso hemorrhage refectory to standard treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (42)
Novo Nordisk Clinical Trial Call Center
Phoenix, Arizona, 85008, United States
Novo Nordisk Clinical Trial Call Center
Los Angeles, California, 90033, United States
Novo Nordisk Clinical Trial Call Center
Sacramento, California, 95817, United States
Novo Nordisk Clinical Trial Call Center
Colorado Springs, Colorado, 80909, United States
Novo Nordisk Clinical Trial Call Center
Washington D.C., District of Columbia, 20010-2975, United States
Novo Nordisk Clinical Trial Call Center
Gainesville, Florida, 32610, United States
Novo Nordisk Clinical Trial Call Center
Jacksonville, Florida, 32209, United States
Novo Nordisk Clinical Trial Call Center
Miami, Florida, 33136, United States
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, 60612, United States
Novo Nordisk Clinical Trial Call Center
Maywood, Illinois, 60153, United States
Novo Nordisk Clinical Trial Call Center
Indianapolis, Indiana, 46202, United States
Novo Nordisk Clinical Trial Call Center
Louisville, Kentucky, 40202, United States
Novo Nordisk Clinical Trial Call Center
Portland, Maine, 04102, United States
Novo Nordisk Clinical Trial Call Center
Baltimore, Maryland, 21201, United States
Novo Nordisk Clinical Trial Call Center
Boston, Massachusetts, 02118, United States
Novo Nordisk Clinical Trial Call Center
Detroit, Michigan, 48201, United States
Novo Nordisk Clinical Trial Call Center
Springfield, Missouri, 65804, United States
Novo Nordisk Clinical Trial Call Center
St Louis, Missouri, 63110-0250, United States
Novo Nordisk Clinical Trial Call Center
Las Vegas, Nevada, 89102, United States
Novo Nordisk Clinical Trial Call Center
Camden, New Jersey, 08103, United States
Novo Nordisk Clinical Trial Call Center
Brooklyn, New York, 11203, United States
Novo Nordisk Clinical Trial Call Center
The Bronx, New York, 10461, United States
Novo Nordisk Clinical Trial Call Center
Greenville, North Carolina, 27835-6028, United States
Novo Nordisk Clinical Trial Call Center
Winston-Salem, North Carolina, 27157, United States
Novo Nordisk Clinical Trial Call Center
Akron, Ohio, 44304, United States
Novo Nordisk Clinical Trial Call Center
Cleveland, Ohio, 44109, United States
Novo Nordisk Clinical Trial Call Center
Columbus, Ohio, 43214, United States
Novo Nordisk Clinical Trial Call Center
Oklahoma City, Oklahoma, 73104, United States
Novo Nordisk Clinical Trial Call Center
Portland, Oregon, 97239-3098, United States
Novo Nordisk Clinical Trial Call Center
Allentown, Pennsylvania, 18103, United States
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, 19102, United States
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, 19104, United States
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, 19140-5189, United States
Novo Nordisk Clinical Trial Call Center
Pittsburgh, Pennsylvania, 15213-2582, United States
Novo Nordisk Clinical Trial Call Center
Providence, Rhode Island, 02903, United States
Novo Nordisk Clinical Trial Call Center
Memphis, Tennessee, 38163, United States
Novo Nordisk Clinical Trial Call Center
Nashville, Tennessee, 37212, United States
Novo Nordisk Clinical Trial Call Center
Fort Sam Houston, Texas, 78234-6315, United States
Novo Nordisk Clinical Trial Call Center
Lackland Air Force Base, Texas, 78236-5300, United States
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, 78229-3900, United States
Novo Nordisk Clinical Trial Call Center
Salt Lake City, Utah, 84143, United States
Novo Nordisk Clinical Trial Call Center
Madison, Wisconsin, 53792, United States
Related Links
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Bartholomew Tortella, MD
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 8, 2006
First Posted
May 9, 2006
Study Start
May 1, 2006
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
June 27, 2012
Record last verified: 2012-03