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

NCT ID: NCT00323570

Last Updated: 2012-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acquired Bleeding Disorder Trauma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

activated recombinant human factor VII

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Trauma injury (blunt and/or penetrating) with evidence of active torso hemorrhage refectory to standard treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Novo Nordisk A/S

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bartholomew Tortella, MD

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novo Nordisk Clinical Trial Call Center

Phoenix, Arizona, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Los Angeles, California, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Sacramento, California, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Colorado Springs, Colorado, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Washington D.C., District of Columbia, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Gainesville, Florida, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Jacksonville, Florida, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Miami, Florida, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Chicago, Illinois, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Maywood, Illinois, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Indianapolis, Indiana, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Louisville, Kentucky, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Portland, Maine, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Baltimore, Maryland, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Boston, Massachusetts, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Detroit, Michigan, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Springfield, Missouri, United States

Site Status

Novo Nordisk Clinical Trial Call Center

St Louis, Missouri, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Las Vegas, Nevada, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Camden, New Jersey, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Brooklyn, New York, United States

Site Status

Novo Nordisk Clinical Trial Call Center

The Bronx, New York, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Greenville, North Carolina, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Winston-Salem, North Carolina, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Akron, Ohio, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Cleveland, Ohio, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Columbus, Ohio, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Oklahoma City, Oklahoma, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Portland, Oregon, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Allentown, Pennsylvania, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Philadelphia, Pennsylvania, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Philadelphia, Pennsylvania, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Philadelphia, Pennsylvania, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Pittsburgh, Pennsylvania, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Providence, Rhode Island, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Memphis, Tennessee, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Nashville, Tennessee, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Fort Sam Houston, Texas, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Lackland Air Force Base, Texas, United States

Site Status

Novo Nordisk Clinical Trial Call Center

San Antonio, Texas, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Salt Lake City, Utah, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

F7TRAUMA-1648

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.