Use of Activated Recombinant Human Factor VII in Cardiac Surgery

Phase 2

Terminated

• Conditions: Acquired Bleeding Disorder; Cardiac Surgery Requiring Cardiopulmonary Bypass

• Registration Number: NCT00154427
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-12
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of critical, serious adverse events	Within 30 days

Secondary Outcome Measures

Name	Time	Method
Surgical drainage volume	For the duration of the trial
Amount of transfusions	For the duration of the trial

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Southampton, United Kingdom