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

Fresh frozen plasma (FFP) or quarantine plasma derived from male-only donors
was the only plasma product available in the Netherlands till 2013. However,
there are some potential risk in using FFP such as transmission of
lipid-envelloped viruses and allergic reactions. Therefore many country*s has
changed their clinical practice and are using solvent-detergent-treated plasma
nowadays. In 2013 Sanquin Dutch Blood Supply introduced
solvent-detergent-treated (S/D) and pooled plasma named (Omniplasma) in the
Netherlands following advice of the Medical advisory board of Sanquin.
Omniplasma is a pooled product of around 600 Dutch donors and is S/D treated
to destroys the lipid enveloped viruses. In addition there is a prion-reducing
step and due to filtration all cells and cell fragments are removed [2]. Since
that time Omniplasma is replacing FFP in the Netherlands. However, FFP and S/D
plasma are not the same products. In vitro and in vivo studies has shown that
S/D plasma is more pro-coagulant, but also more fibrinolytic compared to FFP.
Due to the S/D process not only viruses but probably also other proteins,
especially the more fragile proteins of the coagulation cascade such as protein
S and α2-antiplasmin are destroyed. Therefore the contents of the coagulation
factors between the two products are different. However, those studies who
investigated the difference between S/D plasma and FFP are performed only in
adults not in paediatric cardiac surgery patients.
At the moment during pediatric cardiac surgery, we are still using FFP. However
FFP is going to be replaced by Omniplasma. But because the coagulation profile
is different between the two products and no data is available in these patient
category, we want to perform an implementation study, observing the differences
in coagulation between FFP and Omniplasma in pediatric cardiac surgery.

This study has been transitioned to CTIS with ID 2024-514073-22-01 check the CTIS register for the current data.

To investigate differences in coagulation between (Omniplasma) and FFP in
paediatric cardiac patients, who are undergoing cardiac surgery.

prospective observational implementation study

The risk of participating in the study is negligible. All patients will receive
standard care. During routine sampling from an indwelling catheter placed
during anaesthesia as part of the standard treatment during cardiac surgery, 3
times blood samples will be drawn. The final blood sample will be taken
approximately around 24 hours after surgery or just before the catheter is
removed. No additional punctures will be done for the study.