BridgeMD
A study of fibrinogen concentrate (FGTW) compared to placebo in the management of bleeding in patients undergoing complex cardiac surgery
EU CTIS ID: 2024-512388-29-00
What this study is testing
The primary objective of the study is to evaluate the efficacy of FGTW in combination with Standard of care versus Placebo in combination with Standard of care in reducing the need for allogeneic transfusions during the first 24 hours after IMP administration in complex cardiac surgery patients.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female adult patients ≥18 years
- Patients undergoing a planned complex cardiac surgery procedure involving CPB, including reoperation and/or complex surgical procedures. Complex surgical procedures are defined as any procedure other than first time isolated coronary artery bypass grafting (CABG), single valve repair/replacement and repair of atrial septal defect (ASD). This criterion represents the main eligibility criterion and so used in the definition of the full analysis set.
- With a FIBTEM MCF ≤10 mm during the last 20 minutes of CPB.
- Patients requiring an IMP dose ≤8 g calculated with the formula based on patient's weight and the value of FIBTEM MCF
- Signed and dated informed consent form (ICF)
- Willingness to comply with all study procedures and availability for the duration of the study
You likely can't join if
- Heart transplantation
- Excessive hemodilution with hematocrit (Ht) <22% in men and women at the time of taking sample for FIBTEM MCF during the last 20 minutes of CPB
- Congenital coagulation deficiencies (von Willebrand disease, factor V Leiden, Protein C deficiency, cryoglobulinemia, antiphospholipid syndrome…)
- Any known thromboembolic disorder
- Female of reproductive potential not using effective contraception (condoms; occlusive caps with spermicide; injectable, patch, or combined oral estro-progestative or progestative contraceptives; depot intramuscular medroxyprogesterone; or subcutaneous implants of progestative contraceptive implants) for at least one month prior to screening
- Known pregnancy or positive blood pregnancy test for women of childbearing potential and/or breast-feeding women
See the full eligibility criteria
Who can join
- Male or female adult patients ≥18 years
- Patients undergoing a planned complex cardiac surgery procedure involving CPB, including reoperation and/or complex surgical procedures. Complex surgical procedures are defined as any procedure other than first time isolated coronary artery bypass grafting (CABG), single valve repair/replacement and repair of atrial septal defect (ASD). This criterion represents the main eligibility criterion and so used in the definition of the full analysis set.
- With a FIBTEM MCF ≤10 mm during the last 20 minutes of CPB.
- Patients requiring an IMP dose ≤8 g calculated with the formula based on patient's weight and the value of FIBTEM MCF
- Signed and dated informed consent form (ICF)
- Willingness to comply with all study procedures and availability for the duration of the study
- Covered by healthcare insurance in accordance with local requirements
- FIBTEM MCF ≤14 mm during the screening period prior to the surgery. FIBTEM MCF is the recommended test, for consistency with end of CPB FIBTEM MCF. Fibrinogen concentration (Clauss method) may be substituted, with fibrinogen level ≤3 g/L. Note: the objective of this criterion is to allow to screen fail patients unlikely to meet inclusion criterion #3 prior to surgery rather than at the end of CPB and reduce the patient’s and site’s constraints of continuing the screening process throughout surgery. However, a patient with a preoperative FIBTEM MCF > 14 mm (or plasma fibrinogen > 3 g/L) can, under exceptional circumstances, continue to be screened until FIBTEM MCF measurement during the last 20 minutes of CPB, if, in the investigator’s judgement, the patient is considered at high risk of clinically significant bleeding (e.g., complex multiple procedures or an expected very long duration - several hours - of CPB).
What rules you out
- Heart transplantation
- Excessive hemodilution with hematocrit (Ht) <22% in men and women at the time of taking sample for FIBTEM MCF during the last 20 minutes of CPB
- Congenital coagulation deficiencies (von Willebrand disease, factor V Leiden, Protein C deficiency, cryoglobulinemia, antiphospholipid syndrome…)
- Any known thromboembolic disorder
- Female of reproductive potential not using effective contraception (condoms; occlusive caps with spermicide; injectable, patch, or combined oral estro-progestative or progestative contraceptives; depot intramuscular medroxyprogesterone; or subcutaneous implants of progestative contraceptive implants) for at least one month prior to screening
- Known pregnancy or positive blood pregnancy test for women of childbearing potential and/or breast-feeding women
- Participation in another clinical study involving an investigational medicinal product within 30 days prior to screening or or 5 half-lives of this investigational medicinal product, whichever is longer, or concomitantly with this study
- Treatment with fibrinogen concentrate or cryoprecipitate within 32 days prior to randomization
- Previous cardiac surgical procedure within three months before randomization
- Evidence or suspicion of infection (fever >38.5°C and white blood cell count >11/mm3)
- Active endocarditis
- Repair of complex congenital abnormalities
- Emergency surgery, patients in cardiogenic shock, or expected mortality within 24 hours of surgery
- Pre-existing thrombocytopenia with platelet count < 150 000/ mm3
- Any known pulmonary, hepatic, or renal disease or any other major concomitant significant medical condition that might interfere with treatment evaluation according to the Investigator's judgment
- Known hypersensitivity or other severe reaction to any component of the IMP
- Patients at high risk of thrombotic events unable to stop prophylactic low-molecular-weight heparin (LMWH) 12 hours and fondaparinux 24 hours before surgery (longer interval in case of impaired renal function)
- Patients unable to stop treatment by vitamin K antagonists 3-5 days before surgery to obtain an international normalized ratio (INR) <1.5
- Patients unable to stop treatment by direct oral anticoagulant at least 48 hours before surgery (except aspirin)
- 8. Patients unable to stop treatment by P2Y12 inhibitors before surgery (discontinuation duration before surgery: ticagrelor 3 days, clopidogrel 5 days, and prasugrel 7 days)
- Severe anemia with hemoglobin (Hb) ≤10 g/dL
The study team makes the final eligibility decision.
Where it's taking place
- Serbia
- United Kingdom
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Serbia; United Kingdom; Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.