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Prevention of postoperative bleeding after complex pediatric cardiac surgery by early administration of fibrinogen, prothrombin complex and platelets: a prospective observational study

Conditions
Bleeding after complex pediatric cardiac surgery with cardiopulmonary Bypass.Thrombosis after coagulation therapy, mortality, re-operation
Registration Number
DRKS00018109
Lead Sponsor
CLS Behring GmbH, Marburg
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
50
Inclusion Criteria

Cardiopulmonary Bypass > 90 minutes
in neonates, cyanotic cardiac disease, reoperation, aortic or hypothermic surgery (< 32°C)

Exclusion Criteria

Pre-existing coagulation disorders or anticoagulant or antiplatelet therapy.

Study & Design

Study Type
observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Evaluate the efficacy of an early preventive administration of coagulation factors after CPB (Cardiopulmonary bypass) in the OR in accordance with clinical bleeding evaluation and its effects on TEG (thromboelastography) and standard coagulation Parameters at the OR and after 12 hours on ICU.
Secondary Outcome Measures
NameTimeMethod
Re-operation, outcome, thrombosis
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