Congenital Heart Disease
Conditions
Keywords
Bleeding, Coagulopathy, Heart surgery, Cardiopulmonary bypass
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.
Interventions
BIOLOGICALPlatelet transfusion
Platelets (10 ml/kg body weight) is transfused.
BIOLOGICALFibrinogen concentrate
Fibrinogen concentrate (300 mg/kg body weight) is administered.
Sponsors
Sahlgrenska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HEPTEM-A10 | 45 minutes after intervention | The outcome measure is a measure of global coagulation efficacy, obtained by ROTEM analysis. |
Secondary
| Measure | Time frame |
|---|---|
| Amount of transfused packed red blood cells | up to first postoperative morning |
Countries
Sweden
Contacts
Primary ContactFredrik Söderlund, MD
Backup ContactBirgitta Romlin, MD, PhD
Outcome results
None listed