Use of Activated Recombinant Human Factor VII in Cardiac Surgery

Novo Nordisk

Status and phase: Terminated; Phase 2

Conditions: Cardiac Surgery Requiring Cardiopulmonary Bypass; Acquired Bleeding Disorder

Treatments: Drug: activated recombinant human factor VII

Study type: Interventional

Funder types: Industry

Identifiers

NCT00154427

2004-000100-40 (EudraCT Number)

F7CARD-1610

Details and patient eligibility

About

This trial is conducted in Africa, Asia, Europe, South America and the United States of America (USA).

The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in patients following cardiac surgery.

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Post-operative bleeding according to pre-defined criteria for critical bleeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind