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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00323570
First Posted: May 9, 2006
Last Update Posted: June 27, 2012
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.
Information provided by:
Novo Nordisk A/S
  Purpose

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 Intervention Phase
Acquired Bleeding Disorder Trauma Drug: activated recombinant human factor VII Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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

Secondary Outcome Measures:
  • All cause mortality
  • Hospital-free days
  • Number of transfusion units
  • Days free of renal replacement therapy
  • ICU-free days
  • Days free of ventilator support

Enrollment: 0
Study Start Date: May 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Trauma injury (blunt and/or penetrating) with evidence of active torso hemorrhage refectory to standard treatment
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00323570


  Show 42 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Bartholomew Tortella, MD Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00323570     History of Changes
Other Study ID Numbers: F7TRAUMA-1648
First Submitted: May 8, 2006
First Posted: May 9, 2006
Last Update Posted: June 27, 2012
Last Verified: March 2012

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