CompletedPhase 2/3

Haemocomplettan® P During Elective Complex Cardiac Surgery

Netherlands120 participantsStarted 2011-02

Plain-language summary

Fibrinogen concentrate is increasingly used in cardiac surgery to reverse coagulopathy. Whether its use reduces blood loss, transfusion and occurrence of clinical adverse events remains unknown.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Eighteen years of age or older. * Undergoing elective complex cardiac surgery. * Understood and willingly given written informed consent. * Experience clinically relevant non-surgical microvascular bleeding following removal of cardiopulmonary bypass. Exclusion Criteria: * Positive pregnancy test, pregnancy or lactation. * Undergoing an emergency operation. * Proof or suspicion of a congenital or acquired coagulation disorder. * Clopidogrel use in the 5 days preceding surgery. * INR \>1.4 if on coumadin.

What they're measuring

To determine whether fibrinogen concentrate infusion reduces perioperative blood loss.

Timeframe: within 12 hours.

Trial details

NCT IDNCT01124981

SponsorIsala

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12

View on ClinicalTrials.gov More Fibrinogen Deficiency in Complex Cardiac Surgery trials