Study on Fibrinogen Concentrate (FGTW) for Managing Bleeding in Patients Undergoing Complex Cardiac Surgery

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Region Skane Skanes Universitetssjukhus	Lund	Sweden
IRCCS Policlinico San Donato	San Donato Milanese	Italy
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Hospital Universitario De Cruces	Barakaldo	Spain
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
University Hospital Ostrava	Ostrava	Czechia
Menoextrtcvsgxpcrryfvtunrq Hhlocycaozvmvtks	Halle (Saale)	Germany
Stkqnjgcepqzqwzpgdqhylxwemlvrwpbrz Kfdpigzd Byr Rdlctsslygw Gmya &dbbz Cla Kj	Bad Rothenfelde	Germany
Fjyfkvqn nfqiawzqq Mqwpz a Hndrhcb	Prague	Czechia
Apgdpwf Unmdw Szexzktwo Lrvhub Dp Bfovnxx	Bologna	Italy
Hcadnhtf Dt Lw Slkbr Cjoa I Sxfc Pmc	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	10.10.2023
Germany	Recruiting	10.10.2023
Italy	Recruiting	10.10.2023
Spain	Recruiting	10.10.2023
Sweden	Recruiting	10.10.2023

Trial locations

Investigated drugs:

Human Fibrinogen

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.

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 ID:

2024-512388-29-00

Protocol code:

FGTW2101

Trial Phase:

Therapeutic confirmatory (Phase III)

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