Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Trauma, Acquired Bleeding Disorder

Intervention / Treatment
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* Drug: eptacog alfa (activated)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rFVIIa, Blunt Trauma<br> | Drug: eptacog alfa (activated)<br>* 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.<br>|
| Placebo Comparator: Placebo, Blunt Trauma<br> | Drug: placebo<br>* placebo<br>|
| Experimental: rVIIa, Penetrating Trauma<br> | Drug: eptacog alfa (activated)<br>* 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.<br>|
| Placebo Comparator: Placebo, Penetrating Trauma<br> | Drug: placebo<br>* placebo<br>|

What is the study measuring?
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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 |