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

June 26, 2012 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Novo Nordisk Clinical Trial Call Center
    • California
      • Los Angeles, California, United States, 90033
        • Novo Nordisk Clinical Trial Call Center
      • Sacramento, California, United States, 95817
        • Novo Nordisk Clinical Trial Call Center
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Novo Nordisk Clinical Trial Call Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010-2975
        • Novo Nordisk Clinical Trial Call Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • Novo Nordisk Clinical Trial Call Center
      • Jacksonville, Florida, United States, 32209
        • Novo Nordisk Clinical Trial Call Center
      • Miami, Florida, United States, 33136
        • Novo Nordisk Clinical Trial Call Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Novo Nordisk Clinical Trial Call Center
      • Maywood, Illinois, United States, 60153
        • Novo Nordisk Clinical Trial Call Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Novo Nordisk Clinical Trial Call Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Novo Nordisk Clinical Trial Call Center
    • Maine
      • Portland, Maine, United States, 04102
        • Novo Nordisk Clinical Trial Call Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Novo Nordisk Clinical Trial Call Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Novo Nordisk Clinical Trial Call Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Novo Nordisk Clinical Trial Call Center
    • Missouri
      • Springfield, Missouri, United States, 65804
        • Novo Nordisk Clinical Trial Call Center
      • St. Louis, Missouri, United States, 63110-0250
        • Novo Nordisk Clinical Trial Call Center
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Novo Nordisk Clinical Trial Call Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Novo Nordisk Clinical Trial Call Center
    • New York
      • Bronx, New York, United States, 10461
        • Novo Nordisk Clinical Trial Call Center
      • Brooklyn, New York, United States, 11203
        • Novo Nordisk Clinical Trial Call Center
    • North Carolina
      • Greenville, North Carolina, United States, 27835-6028
        • Novo Nordisk Clinical Trial Call Center
      • Winston-Salem, North Carolina, United States, 27157
        • Novo Nordisk Clinical Trial Call Center
    • Ohio
      • Akron, Ohio, United States, 44304
        • Novo Nordisk Clinical Trial Call Center
      • Cleveland, Ohio, United States, 44109
        • Novo Nordisk Clinical Trial Call Center
      • Columbus, Ohio, United States, 43214
        • Novo Nordisk Clinical Trial Call Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Novo Nordisk Clinical Trial Call Center
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Novo Nordisk Clinical Trial Call Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Novo Nordisk Clinical Trial Call Center
      • Philadelphia, Pennsylvania, United States, 19102
        • Novo Nordisk Clinical Trial Call Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Novo Nordisk Clinical Trial Call Center
      • Philadelphia, Pennsylvania, United States, 19140-5189
        • Novo Nordisk Clinical Trial Call Center
      • Pittsburgh, Pennsylvania, United States, 15213-2582
        • Novo Nordisk Clinical Trial Call Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Novo Nordisk Clinical Trial Call Center
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • Novo Nordisk Clinical Trial Call Center
      • Nashville, Tennessee, United States, 37212
        • Novo Nordisk Clinical Trial Call Center
    • Texas
      • Fort Sam Houston, Texas, United States, 78234-6315
        • Novo Nordisk Clinical Trial Call Center
      • Lackland AFB, Texas, United States, 78236-5300
        • Novo Nordisk Clinical Trial Call Center
      • San Antonio, Texas, United States, 78229-3900
        • Novo Nordisk Clinical Trial Call Center
    • Utah
      • Salt Lake City, Utah, United States, 84143
        • Novo Nordisk Clinical Trial Call Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Novo Nordisk Clinical Trial Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality and Morbidity
Time Frame: through day 30
through day 30

Secondary Outcome Measures

Outcome Measure
All cause mortality
Hospital-free days
Number of transfusion units
Days free of renal replacement therapy
ICU-free days
Days free of ventilator support

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Bartholomew Tortella, MD, Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

May 8, 2006

First Submitted That Met QC Criteria

May 8, 2006

First Posted (Estimate)

May 9, 2006

Study Record Updates

Last Update Posted (Estimate)

June 27, 2012

Last Update Submitted That Met QC Criteria

June 26, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F7TRAUMA-1648

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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