TerminatedPhase 2

Use of Activated Recombinant Human Factor VII in Cardiac Surgery

Stopped: Trial terminated after recruiting 172 patients but without proceeding to the highest dosing cohort as this no longer reflects common clinical practice

United States172 participantsStarted 2004-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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

What they're measuring

Incidence of critical, serious adverse events

Timeframe: Within 30 days

Trial details

NCT IDNCT00154427

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-11

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