Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Due to Trauma

Novo Nordisk

Status and phase: Withdrawn; Phase 3

Conditions: Trauma; Acquired Bleeding Disorder

Treatments: Drug: activated recombinant human factor VII

Study type: Interventional

Funder types: Industry

Identifiers

NCT00323570

F7TRAUMA-1648

Details and patient eligibility

About

This trial is conducted in the United States of America (USA). The purpose of this study is to evaluate the treatment of Recombinant Faction VIIa in Patients with Severe Bleeding Due to Trauma

Please note that this trial and trial F7TRAUMA-1711 (NCT00184548) have been merged.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Trauma injury (blunt and/or penetrating) with evidence of active torso hemorrhage refectory to standard treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind