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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This study has been withdrawn prior to enrollment.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

May 8, 2006
June 26, 2012
May 2006
June 2007   (final data collection date for primary outcome measure)
Mortality and Morbidity [ Time Frame: through day 30 ] [ Designated as safety issue: No ]
Mortality and Morbidity through day 30
Complete list of historical versions of study NCT00323570 on ClinicalTrials.gov Archive Site
  • 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 ]
  • All cause mortality
  • Hospital-free days
  • Number of transfusion units
  • Days free of renal replacement therapy
  • ICU-free days
  • Days free of ventilator support
Not Provided
Not Provided
 
Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Due to Trauma
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Acquired Bleeding Disorder
  • Trauma
Drug: activated recombinant human factor VII
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Trauma injury (blunt and/or penetrating) with evidence of active torso hemorrhage refectory to standard treatment
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00323570
F7TRAUMA-1648
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Bartholomew Tortella, MD Novo Nordisk
Novo Nordisk
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP