Use of Activated Recombinant Human Factor VII in Cardiac Surgery

A Multi-centre, Randomised, Double-blind, Placebocontrolled, Dose Escalation Trial on Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Treatment of Post-operative Bleeding in Patients Following Cardiac Surgery Requiring Cardiopulmonary Bypass

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00154427

Enrollment

172

Registered

2005-09-12

Start date

2004-08-31

Completion date

2007-11-30

Last updated

2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass

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.

Interventions

DRUGactivated recombinant human factor VII

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Incidence of critical, serious adverse events	Within 30 days

Secondary

Measure	Time frame
Surgical drainage volume	For the duration of the trial
Amount of transfusions	For the duration of the trial

Countries

Argentina, Brazil, Denmark, France, Germany, India, Italy, Malaysia, Singapore, South Africa, Spain, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026