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Study on Fibrinogen Concentrate (FGTW) for Managing Bleeding in Patients Undergoing Complex Cardiac 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 managing bleeding in patients who are undergoing complex heart surgery, specifically those involving a procedure called cardiopulmonary bypass (CPB). The study is investigating the use of a treatment called fibrinogen concentrate, which is also known by its code name FGTW. Fibrinogen is a protein that helps blood to clot, and the concentrate is being tested to see if it can reduce the need for blood transfusions during and after surgery. The trial will compare the effects of FGTW with a placebo to determine its effectiveness and safety.

The purpose of the study is to evaluate whether FGTW, when used alongside standard care, can decrease the need for transfusions of blood products within the first 24 hours after surgery. Participants in the study will receive either the fibrinogen concentrate or a placebo through an intravenous infusion, which means the treatment is delivered directly into the bloodstream. The study will monitor the amount of blood products needed, the volume of blood drainage, and other health outcomes over a period of time, including the length of hospital stay and any complications that may arise.

By participating in this study, researchers aim to gather important information on how effective FGTW is in managing bleeding during complex heart surgeries. This could potentially lead to improved treatment options for patients undergoing such procedures. The study is expected to continue until 2026, with recruitment having started in October 2023.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will undergo a screening process to ensure eligibility. This includes confirming the patient is an adult aged 18 or older, undergoing complex cardiac surgery involving cardiopulmonary bypass (CPB), and meeting specific medical criteria related to blood clotting tests.

  2. Step 2

    Randomization

    After eligibility is confirmed, the patient will be randomly assigned to receive either the fibrinogen concentrate (FGTW) or a placebo. This process is double-blind, meaning neither the patient nor the medical staff will know which treatment is being administered.

  3. Step 3

    Administration of treatment

    The treatment, either FGTW or placebo, will be administered through an intravenous infusion during the surgery. The dosage is determined based on the patient's weight and specific blood test results.

  4. Step 4

    Post-surgery monitoring

    Following the surgery, the patient will be closely monitored for 24 hours. The primary focus is on the number of blood transfusions required, as well as the volume of blood drainage.

  5. Step 5

    Follow-up assessments

    The patient will undergo several follow-up assessments to evaluate recovery and any potential side effects. These assessments will occur at 24 hours, 7 days, and 30 days post-randomization. Key factors include surgical recovery, kidney function, and overall health status.

  6. Step 6

    Completion of study participation

    The study participation concludes with the final assessment, which may include a review of the patient's hospital stay duration and any additional treatments received. The estimated end date for the study is April 30, 2026.

Who can join the trial?

8 criteria

  • Male or female adult patients who are **18 years or older**.
  • Patients who are going to have a planned **complex heart surgery** that involves the use of a machine to help circulate blood (called **Cardiopulmonary Bypass** or CPB). This includes surgeries that are not the first time for a simple heart bypass, single valve repair or replacement, or repair of a hole in the heart (known as **atrial septal defect**).
  • Patients with a **FIBTEM MCF** (a test that measures how well blood clots) of **10 mm or less** during the last 20 minutes of the CPB.
  • Patients who need a dose of the study medication that is **8 grams or less**, calculated based on their weight and the FIBTEM MCF value.
  • Patients who have signed and dated an **informed consent form**, which means they agree to participate in the study after understanding what it involves.
  • Patients who are willing to follow all the study procedures and are available for the entire duration of the study.
  • Patients who have **healthcare insurance** as required by local laws.
  • Patients with a **FIBTEM MCF** of **14 mm or less** during the screening period before surgery. This is to ensure that patients who are unlikely to meet the criteria during surgery are identified early. In some cases, if a patient is at high risk of significant bleeding, they may continue to be screened even if their FIBTEM MCF is higher than 14 mm before surgery.

Who cannot join the trial?

5 criteria

  • Patients who are not undergoing complex heart surgery that involves the use of a machine to help circulate blood and oxygen during the procedure.
  • Patients who are not experiencing bleeding during the surgery.
  • Patients who are not within the specified age range for the study.
  • Patients who do not meet the gender requirements for the study.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

FGTW is a fibrinogen concentrate used in this study. It is being tested to see if it can help manage bleeding in patients undergoing complex heart surgery. The goal is to determine if FGTW can reduce the need for blood transfusions within the first 24 hours after surgery when used alongside standard care.

What is already known about the treatment

Fibrinogen Concentrate (FGTW) – This medication is administered intravenously and is currently being studied in a phase 3 clinical trial. It is used to manage bleeding in patients undergoing complex cardiac surgery that involves cardiopulmonary bypass. The main therapeutic indication is to reduce the need for blood transfusions within the first 24 hours after surgery. At the molecular level, fibrinogen concentrate works by increasing the levels of fibrinogen, a protein essential for blood clot formation, thereby enhancing the body's ability to form clots and stop bleeding. It is classified as a hemostatic agent.

Investigated diseases

Bleeding in patients undergoing complex cardiac surgery involving Cardiopulmonary bypass – This condition occurs when patients experience excessive bleeding during or after complex heart surgeries that require the use of a heart-lung machine, known as cardiopulmonary bypass. The bleeding can be due to various factors, including the effects of the surgery itself, the use of anticoagulant medications, or underlying blood clotting disorders. During the procedure, the blood is diverted from the heart and lungs to the machine, which can affect normal blood clotting processes. As a result, patients may require blood transfusions to manage the bleeding. The condition is closely monitored to prevent complications and ensure the patient's stability during the recovery period.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512388-29-00Protocol codeFGTW2101Estimated enrolment180 patientsSponsorLFB-Biotechnologies

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).