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

Sahlgrenska University Hospital

Status and phase: Unknown; Phase 2

Conditions: Congenital Heart Disease

Treatments: Biological: Platelet transfusion; Biological: Fibrinogen concentrate

Study type: Interventional

Funder types: Other

Identifiers

NCT04807621

FS52016

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Platelets

Active Comparator group

Description:

Patients recieve, in the presence of significant bleeding and pathological results of ROTEM analysis, a platelet transfusion.

Treatment:

Biological: Platelet transfusion

Fibrinogen

Experimental group

Description:

Patients recieve, in the presence of significant bleeding and pathological results of ROTEM analysis, fibrinogen concentrate.

Treatment:

Biological: Fibrinogen concentrate