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

Novo Nordisk

Status and phase: Terminated; Phase 3

Conditions: Trauma; Acquired Bleeding Disorder

Treatments: Drug: placebo; Drug: eptacog alfa (activated)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00184548

2005-002059-41 (EudraCT Number)

F7TRAUMA-1711

Details and patient eligibility

About

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.

Full 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.

Enrollment: 554 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

554 participants in 4 patient groups, including a placebo group

rFVIIa, Blunt Trauma

Experimental group

Treatment:

Drug: eptacog alfa (activated)

Placebo, Blunt Trauma

Placebo Comparator group

Treatment:

Drug: placebo

rVIIa, Penetrating Trauma

Experimental group

Treatment:

Drug: eptacog alfa (activated)

Placebo, Penetrating Trauma

Placebo Comparator group

Treatment:

Drug: placebo