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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00323570
Recruitment Status : Withdrawn
First Posted : May 9, 2006
Last Update Posted : June 27, 2012
Information provided by:
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment Phase
Acquired Bleeding Disorder Trauma Drug: activated recombinant human factor VII Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : May 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Mortality and Morbidity [ Time Frame: through day 30 ]

Secondary Outcome Measures :
  1. All cause mortality
  2. Hospital-free days
  3. Number of transfusion units
  4. Days free of renal replacement therapy
  5. ICU-free days
  6. Days free of ventilator support

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00323570

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Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Bartholomew Tortella, MD Novo Nordisk A/S

Additional Information:
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT00323570     History of Changes
Other Study ID Numbers: F7TRAUMA-1648
First Posted: May 9, 2006    Key Record Dates
Last Update Posted: June 27, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Wounds and Injuries
Blood Coagulation Disorders
Hemostatic Disorders
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders