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

Phase 2

• Conditions: Congenital Heart Disease

• Registration Number: NCT04807621
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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 on children with congenital heart defects.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-14
• Status Verified: 2021-03
• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-18
• Last Update Submitted: 2021-03-18
• Study First Posted: 2021-03-19
• Last Update Posted: 2021-03-19
• Primary Completion: 2022-01
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 patient´s age), gestational age < 34 weeks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HEPTEM-A10	45 minutes after intervention	The outcome measure is a measure of global coagulation efficacy, obtained by ROTEM analysis.

Secondary Outcome Measures

Name	Time	Method
Amount of transfused packed red blood cells	up to first postoperative morning

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden