Differences in coagulation between fresh frozen plasma and Solvent-detergent plasma in pediatric congenital heart surgery.

• Conditions: bloedstolling; coagulation; congenitale cardiac surgery; 10064477; 10010394; 10007593

• Registration Number: NL-OMON51227
• Lead Sponsor: Anesthesiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• 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
<p>Primary outcome involves the difference of coagulation variables between<br /><br>transfusion of FFP versus Omniplasma. Coagulation variables of interest are<br /><br>protein C activity, protein S activity, a2-antiplasmin, antithrombin,<br /><br>plasminogen, Hb, thrombocyte count, ROTEM, aPTT, PT and fibrinogen. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are clinical parameters as perioperative and postoperative<br /><br>blood loss, transfusion need, post-operative thrombosis until 30 days after<br /><br>surgery or until discharge from our hospital and costs between the two<br /><br>products. </p><br>