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Differences in coagulation between fresh frozen plasma and Solvent-detergent plasma in pediatric congenital heart surgery.
EU CTIS ID: 2024-514073-22-01
What this study is testing
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 α2-ntiplasmin. Other important coagulation variables are aPTT, PT, ROTEM, fibrinolysis (measured with ROTEM) fibrinogen, Hb, thrombocyte count, protein C activity, antithrombin and plasminogen.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- No informed consent
- Cardiac surgery without the use of CPB
- Preoperative known coagulation disorders
- Known allergy for FFP or Omniplasma
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.