Differences in coagulation between fresh frozen plasma and Solvent-detergent plasma in pediatric congenital heart surgery
Recruiting
- Conditions
- Congetinal pediatric heart disease
- Registration Number
- NL-OMON28246
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
·Informed consent
·Cardiac surgery with the use of CPB
·Group 1A and Group 2A children < 1 year old
·Group 1B and Group 2B Glenn / Fontan surgery
Exclusion Criteria
·No informed consent
·Cardiac surgery without the use of CPB
·Preoperative known coagulation disorders
·Known allergy for FFP or Omniplasma
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the differences in coagulation variables just after surgery between FFP and S/D plasma (Omniplasma) use. The main coagulation variables of interest are protein S activity and a2-antiplasmin. Other important coagulation variables are aPTT, PT, ROTEM, fibrinolysis (measured with ROTEM) fibrinogen, Hb, thrombocyte count, protein C activity, antithrombin and plasminogen.
- Secondary Outcome Measures
Name Time Method Secondary outcomes are the coagulation variables 24 hours after surgery compared to the pre-operative values and clinical parameters such as perioperative and postoperative blood loss, transfusion need and thrombotic events until 30 days after surgery or until discharge from our hospital. In addition, we also investigate if there are differences in costs between the two products.