Platelets or Fibrinogen as First-line Treatment for Bleeding During Pedatric Heart Surgery

  • STATUS
    Recruiting
  • End date
    Aug 25, 2022
  • participants needed
    40
  • sponsor
    Sahlgrenska University Hospital, Sweden
Updated on 25 March 2021

Summary

The study aims to test whether platelet transfusion or fibrinogen concentrate is the most effective treatment of intraoperative bleeding, when performing open heart surgery with cardiopulmonary bypass on children with congenital heart defects.

Details
Condition Congenital Heart Disease
Treatment Platelet transfusion, Fibrinogen concentrate
Clinical Study IdentifierNCT04807621
SponsorSahlgrenska University Hospital, Sweden
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Children < 1 years of age, scheduled for open surgery of congenital heart defects, using cardiopulmonary bypass
Body weight < 10 kg
Expected CPB time > 90 minutes

Exclusion Criteria

Known coagulation disorder, current treatment with antiplatelet and/or anticoagulant drugs, major surgery the past month before the planned surgery, preoperative kidney or liver failure (defined as creatinine and/or transaminases > normal interval for the patients age), gestational age < 34 weeks
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