Use of Activated Recombinant Human Factor VII in Cardiac Surgery

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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

Trial contacts and locations

63

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Data sourced from clinicaltrials.gov

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