Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding

Phase 3TerminatedNCT00184548

Novo Nordisk A/S554 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

554

Conditions

Acquired Bleeding Disorder Trauma

Interventions

eptacog alfa (activated)DRUG

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.

placeboDRUG

placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (14)

Novo Nordisk Clinical Trial Call Center

Princeton, New Jersey, United States

Unnamed facility

Säo Paulo, Brazil

Unnamed facility

Prague, Czechia

Unnamed facility

Outcomes

Primary Outcomes

Mortality

Number of participants to die from day 0 to day 30 from all causes.

Time frame: 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.

Time frame: from day 0 to day 30

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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