Comparison of Coagulation Outcomes Using Fresh Frozen Plasma Versus Solvent-Detergent Plasma in Pediatric Congenital Heart Surgery

The primary objective of this study is to investigate the differences in **coagulation** variables immediately following pediatric congenital heart surgery between the use of fresh frozen plasma (FFP) and solvent-detergent plasma (S/D plasma, Omniplasma). The main coagulation variables of interest include protein S activity and α2-antiplasmin. Additional coagulation parameters being evaluated are activated partial thromboplastin time (aPTT), prothrombin time (PT), rotational thromboelastometry (ROTEM), fibrinolysis (measured with ROTEM), fibrinogen, hemoglobin (Hb), thrombocyte count, protein C activity, antithrombin, and plasminogen. Understanding these differences is clinically relevant as it may influence the choice of plasma product used during surgery, potentially impacting patient outcomes and recovery.

The clinical trial focuses on **coagulation** in pediatric cardiac surgery, specifically investigating differences in coagulation variables post-surgery between the use of FFP and S/D plasma (Omniplasma). The study population includes both male and female subjects under the age of one year, undergoing cardiac surgery with the use of cardiopulmonary bypass (CPB), as well as those undergoing Glenn or Fontan surgery. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on specific inclusion criteria, including informed consent and the type of cardiac surgery. No additional lifestyle considerations such as diet or physical activity are specified for this trial.

The clinical trial is designed to evaluate the differences in **coagulation** variables following pediatric cardiac surgery using either fresh frozen plasma (FFP) or solvent-detergent plasma (Omniplasma). This study employs a randomized, double-blind, controlled trial design to ensure unbiased results. The trial is expected to span from July 2021 to July 2027, with participant involvement lasting up to one day, as the maximum treatment period is limited to a single day. The primary outcome focuses on the difference in coagulation variables such as protein C activity, protein S activity, α2-antiplasmin, antithrombin, plasminogen, hemoglobin (Hb), thrombocyte count, ROTEM, activated partial thromboplastin time (aPTT), prothrombin time (PT), and fibrinogen, measured immediately after surgery.

Participants will undergo a sequence of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as informed consent, undergoing cardiac surgery with cardiopulmonary bypass (CPB), and specific age and surgical group requirements. Follow-up visits are not specified due to the short duration of participant involvement. The end-of-study visit will coincide with the completion of the primary outcome measurements post-surgery. Conditions that may lead to early termination from the study include withdrawal of consent or any adverse events that compromise participant safety. The trial aims to provide valuable insights into the coagulation differences between the two plasma products in the context of pediatric cardiac surgery.

The clinical trial involves the administration of **Omniplasma**, a **solution for infusion** containing **human plasma protein** as the active substance. This experimental medication is provided in a concentration of 45-70 mg/ml and is administered via **infusion**. The maximum daily and total dose is 3500 ml, with a treatment period limited to one day. The product is manufactured by Octapharma GmbH and is classified under the ATC code B05AA, which pertains to blood substitutes and plasma protein fractions. The **human plasma protein** is derived from a structurally diverse blood source, ensuring a comprehensive profile of plasma proteins.

The comparator treatment in this study is **PLASMA**, which is also a **solution for injection**. This non-experimental treatment is administered through **intravenous infusion**. Similar to Omniplasma, the maximum daily and total dose for PLASMA is 3500 ml, with a treatment period of one day. The active substance in this treatment is simply referred to as **plasma**, categorized as a protein of other origin. This comparator serves to evaluate the differences in coagulation variables post-surgery in pediatric congenital heart surgery patients.

Efficacy in this clinical trial will be assessed by evaluating the differences in coagulation variables between the use of fresh frozen plasma (FFP) and solvent-detergent plasma (Omniplasma) in pediatric congenital heart surgery. The primary endpoints include the measurement of coagulation variables such as protein C activity, **protein S activity**, α2-antiplasmin, antithrombin, plasminogen, hemoglobin (Hb), thrombocyte count, ROTEM, activated partial thromboplastin time (aPTT), prothrombin time (PT), and fibrinogen. These variables will be measured just after surgery to determine the efficacy of the plasma products used.