Status:
UNKNOWN
Platelets or Fibrinogen as First-line Treatment for Bleeding During Pedatric Heart Surgery
Lead Sponsor:
Sahlgrenska University Hospital
Conditions:
Congenital Heart Disease
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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 patient´s age), gestational age \< 34 weeks.
Key Trial Info
Start Date :
March 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04807621
Start Date
March 14 2018
End Date
August 1 2022
Last Update
March 19 2021
Active Locations (1)
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1
Sahlgrenska University Hospital
Gothenburg, Sweden