Use of Activated Recombinant Human Factor VII in Cardiac Surgery

Phase 2TerminatedNCT00154427

Novo Nordisk A/S172 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

172

Conditions

Acquired Bleeding Disorder Cardiac Surgery Requiring Cardiopulmonary Bypass

Interventions

activated recombinant human factor VIIDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (63)

Outcomes

Primary Outcomes

Incidence of critical, serious adverse events

Time frame: Within 30 days

Secondary Outcomes

Surgical drainage volume

Time frame: For the duration of the trial

Amount of transfusions

Time frame: For the duration of the trial

Data from ClinicalTrials.gov

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