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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This study has been withdrawn prior to enrollment.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:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00323570
First received: May 8, 2006
Last updated: June 26, 2012
Last verified: March 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Mortality and Morbidity [ Time Frame: through day 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All cause mortality [ Designated as safety issue: No ]
  • Hospital-free days [ Designated as safety issue: No ]
  • Number of transfusion units [ Designated as safety issue: No ]
  • Days free of renal replacement therapy [ Designated as safety issue: No ]
  • ICU-free days [ Designated as safety issue: No ]
  • Days free of ventilator support [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323570

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

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00323570     History of Changes
Other Study ID Numbers: F7TRAUMA-1648
Study First Received: May 8, 2006
Last Updated: June 26, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013