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Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding (CONTROL)

This study has been terminated.
(See termination reason in detailed description)
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184548
First received: September 9, 2005
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

This trial is conducted globally. The purpose of the trial is to evaluate that activated recombinant human factor VII (eptacog alfa (activated)) is safe and effective in severely injured trauma patients by assessing mortality and morbidity.

Please note that this trial and trial F7TRAUMA-1648 (NCT00323570) have been merged.


Condition Intervention Phase
Acquired Bleeding Disorder
Trauma
Drug: eptacog alfa (activated)
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®/NiaStase®) in Severely Injured Trauma Patients With Bleeding Refractory to Standard Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Mortality [ Time Frame: from day 0 to 30 ]
    Number of participants to die from day 0 to day 30 from all causes.

  • Morbidity [ Time Frame: from day 0 to day 30 ]
    Morbidity reflects the number of patients who had pulmonary and/or renal dysfunction requiring ongoing medical intervention on day 30.


Secondary Outcome Measures:
  • Number of Days Alive and Free of Pulmonary and/or Renal Dysfunction Requiring Medical Intervention [ Time Frame: from day 0 to day 30 ]
    The number of days alive and free of pulmonary and/or renal dysfunction requiring medical intervention from day 0 to day 30.

  • Time to Death From Time of First Dose [ Time Frame: from day 0 to day 30 ]
    The time of first dose refers to the time of the first dose of rFVIIa or placebo.

  • Number of Units of Transfused Red Blood Cells From Time of First Dose [ Time Frame: from hour 0 to 24 ]
    The number of units of transfused red blood cells in the first 24 hours from the time of the first dose of rFVIIa or placebo.

  • Number of Patients Receiving 10 Units or More (Massive Transfusion) of Red Blood Cells From Time of Injury [ Time Frame: from hour 0 to 24 ]
    The number of patients receiving 10 units or more of red blood cells in the first 24 hours from the time of injury.

  • Number of Units of All Allogeneic Transfusions From Time of First Dose [ Time Frame: from hour 0 to 24 ]
    The number of units of all allogeneic transfusions in the first 24 hours from the time of the first dose of rFVIIa or placebo.


Enrollment: 554
Study Start Date: October 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rFVIIa, Blunt Trauma Drug: eptacog alfa (activated)

Sterile, freeze-dried powder in single-use vials to be reconstituted with sterile water for injection.

Three doses of 200, 100 and 100 mcg/kg to be administered bolus i.v. (intravenous) over approx. three hours.

Placebo Comparator: Placebo, Blunt Trauma Drug: placebo
placebo
Experimental: rVIIa, Penetrating Trauma Drug: eptacog alfa (activated)

Sterile, freeze-dried powder in single-use vials to be reconstituted with sterile water for injection.

Three doses of 200, 100 and 100 mcg/kg to be administered bolus i.v. (intravenous) over approx. three hours.

Placebo Comparator: Placebo, Penetrating Trauma Drug: placebo
placebo

Detailed Description:
The decision to discontinue the F7TRAUMA-1711 trial is not due to any safety concerns. The result of the pre-planned futility analysis performed in June 2008 predicted a very low likelihood of reaching a successful outcome on the primary efficacy endpoint at the end of the trial and as a consequence, the company has decided to close the trial as this juncture.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Trauma injury (blunt and/or penetrating) with evidence of active hemorrhage (torso and/or proximal lower extremity) refractory to blood component therapy and surgical haemostatic procedures at the time of randomisation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184548

Locations
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, United States, 08540
Brazil
Säo Paulo, Brazil, 05001-400
Czech Republic
Prague, Czech Republic, 16000
France
Paris La défense cedex, France, 92932
Germany
Mainz, Germany, 55127
Greece
Vouliagment, Greece, 16671
Hong Kong
Kowloon, Hong Kong
Hungary
Budapest, Hungary, 1025
Italy
Rome, Italy, 00144
Netherlands
Alphen a/d Rijn, Netherlands
South Africa
Sandton, South Africa, 2146
Spain
Madrid, Spain, 28033
Switzerland
Zurich, Switzerland, CH-8050
United Kingdom
Crawley, United Kingdom, RH11 9RT
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00184548     History of Changes
Other Study ID Numbers: F7TRAUMA-1711
2005-002059-41 ( EudraCT Number )
Study First Received: September 9, 2005
Results First Received: September 4, 2009
Last Updated: June 13, 2014

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

ClinicalTrials.gov processed this record on March 22, 2017