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

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

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.

Study Overview

• Status: Terminated
• Conditions: Trauma; Acquired Bleeding Disorder
• Intervention / Treatment: Drug: placebo; Drug: eptacog alfa (activated)

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.

• Study Type: Interventional
• Enrollment (Actual): 554
• Phase: Phase 3

Contacts and Locations

Study Locations

• 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
• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Novo Nordisk Clinical Trial Call Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Number of participants to die from day 0 to day 30 from all causes.	from day 0 to 30
Morbidity	Morbidity reflects the number of patients who had pulmonary and/or renal dysfunction requiring ongoing medical intervention on day 30.	from day 0 to day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Days Alive and Free of Pulmonary and/or Renal Dysfunction Requiring Medical Intervention	The number of days alive and free of pulmonary and/or renal dysfunction requiring medical intervention from day 0 to day 30.	from day 0 to day 30
Time to Death From Time of First Dose	The time of first dose refers to the time of the first dose of rFVIIa or placebo.	from day 0 to day 30
Number of Units of Transfused Red Blood Cells From Time of First Dose	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.	from hour 0 to 24
Number of Patients Receiving 10 Units or More (Massive Transfusion) of Red Blood Cells From Time of Injury	The number of patients receiving 10 units or more of red blood cells in the first 24 hours from the time of injury.	from hour 0 to 24
Number of Units of All Allogeneic Transfusions From Time of First Dose	The number of units of all allogeneic transfusions in the first 24 hours from the time of the first dose of rFVIIa or placebo.	from hour 0 to 24

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): June 25, 2014
• Last Update Submitted That Met QC Criteria: June 13, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage
• Other Study ID Numbers: F7TRAUMA-1711; 2005-002059-41 (EudraCT Number)