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Study on Coagulation Differences Using Fresh Frozen Plasma and Solvent-Detergent Plasma in Children Undergoing Congenital Heart Surgery

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying blood clotting in children undergoing heart surgery. The study compares two types of plasma, which is a component of blood. The first type is called fresh frozen plasma, and the second type is Solvent-detergent plasma, known by the brand name Omniplasma. Plasma is important in helping blood to clot properly, which is crucial during and after surgery.

The purpose of the study is to investigate how these two types of plasma affect blood clotting in children who have heart surgery. The study will look at various factors related to blood clotting, such as the activity of certain proteins and the number of blood cells that help with clotting. These factors include protein S activity, α2-antiplasmin, and others like fibrinogen and thrombocyte count, which are important for understanding how well the blood can clot after surgery.

During the study, children undergoing heart surgery will receive either fresh frozen plasma or Omniplasma. The researchers will then measure the blood clotting factors shortly after the surgery to see if there are any differences between the two types of plasma. This information will help doctors understand which type of plasma might be better for children having heart surgery, ensuring they receive the best possible care.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after providing informed consent.
Eligibility includes undergoing cardiac surgery with the use of a heart-lung machine, known as cardiopulmonary bypass (CPB).
Participants are children under 1 year old or those undergoing specific surgeries like Glenn or Fontan procedures.
Step 2
Surgery and treatment
During surgery, participants receive either fresh frozen plasma (FFP) or Solvent-detergent plasma (Omniplasma).
Omniplasma is administered as a solution for infusion through an intravenous infusion.
Step 3
Post-surgery monitoring
After surgery, differences in blood clotting are measured.
Key measurements include protein S activity, α2-antiplasmin, and other clotting factors like aPTT, PT, and ROTEM.
Step 4
Outcome assessment
The primary outcome focuses on the differences in clotting factors between the use of FFP and Omniplasma.
Measurements include protein C activity, antithrombin, plasminogen, hemoglobin (Hb), and thrombocyte count.

Who can join the trial?

5 criteria

The patient must have a signed informed consent. This means that the patient's parents or guardians have agreed to participate in the study after understanding what it involves.
The patient must be undergoing cardiac surgery with the use of CPB. CPB stands for cardiopulmonary bypass, which is a machine that takes over the function of the heart and lungs during surgery.
The patient must be in Group 1A or Group 2A and be less than 1 year old.
The patient must be in Group 1B or Group 2B and undergoing Glenn or Fontan surgery. These are specific types of heart surgeries.
Both male and female patients are eligible to participate.

Who cannot join the trial?

10 criteria

Patients who are not undergoing pediatric cardiac surgery.
Patients who are not within the specified age range for the study.
Patients who have any medical condition that might interfere with the study results.
Patients who are part of a vulnerable population, meaning they might need special protection or care.
Patients who are not able to follow the study procedures or instructions.
Patients who have participated in another clinical trial recently, which might affect the study outcomes.
Patients who have any allergies or reactions to the substances used in the study.
Patients who have any bleeding disorders, which means their blood does not clot properly.
Patients who are taking medications that could interfere with blood clotting.
Patients who have any serious health conditions that could affect their participation in the study.

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Verified sites

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Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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Rotterdam, The Netherlands

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Investigated drugs

Fresh Frozen Plasma (FFP)
is a blood product used in the clinical trial to help improve blood clotting in children undergoing heart surgery. It is made from the liquid part of whole blood and contains important proteins that help with clotting. The trial aims to see how well FFP works in managing bleeding and supporting coagulation after surgery.
Solvent-Detergent Plasma (Omniplasma)
is another type of plasma used in the trial. It is treated with a solvent-detergent process to reduce the risk of transmitting infections. Like FFP, it contains proteins that are crucial for blood clotting. The trial compares its effectiveness to FFP in helping with coagulation in pediatric heart surgery patients.

What is already known about the treatment

Omniplasma – Omniplasma is administered intravenously and is used in medical settings, particularly during surgeries. It is currently being studied in clinical trials to assess its effectiveness in managing coagulation during pediatric cardiac surgery. The main therapeutic indication for Omniplasma is to support blood clotting processes in patients undergoing heart surgery. At the molecular level, it works by providing essential proteins and factors that aid in blood coagulation, such as protein S and antiplasmin. Omniplasma is classified as a blood plasma product, specifically solvent-detergent treated plasma, which is designed to reduce the risk of viral transmission.

Investigated diseases

Coagulation in Pediatric Cardiac Surgery – This condition involves the process of blood clotting in children undergoing heart surgery. During and after surgery, the body's ability to form clots can be affected, which is crucial for preventing excessive bleeding. The condition is characterized by changes in various coagulation factors, such as protein S activity, protein C activity, and antithrombin levels. It also involves monitoring other blood components like fibrinogen, thrombocyte count, and plasminogen. The condition is assessed using tests like aPTT, PT, and ROTEM to evaluate clotting function. Understanding these changes is essential for managing bleeding risks during and after surgery.