A study of fibrinogen concentrate (FGTW) compared to placebo in the management of bleeding in patients undergoing complex cardiac surgery

A multicenter, randomized, double-blind, placebo-controlled, parallel, phase 3 study to assess the efficacy and safety of fibrinogen concentrate (FGTW) in the management of bleeding in patients undergoing complex cardiac surgery (involving CPB)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-001759-17-SE

Enrollment

176

Registered

2022-07-22

Start date

2022-10-04

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding in patients undergoing complex cardiac surgery (involving CPB) MedDRA version: 20.0 Level: LLT Classification code 10017501 Term: Functional disturbances following cardiac surgery System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Trade Name: FibCLOT Product Name: FibCLOT®/ FibriCLOTte® Pharmaceutical Form: Powder and solution for solution for injection INN or Proposed INN: Human fibrinogen CAS Number: 9001-32-5 Current Sponsor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A patient must meet all the following criteria to be eligible to participate in this study: 1. Male or female adult patients =18 years 2. 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. 3. With a FIBTEM MCF =10 mm during the last 20 minutes of CPB. 4. Patients requiring an IMP dose =8 g calculated with the formula based on patient’s weight and the value of FIBTEM MCF 5. Signed and dated informed consent form (ICF) 6. Willingness to comply with all study procedures and availability for the duration of the study 7. Covered by healthcare insurance in accordance with local requirements 8. 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 158 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18

Exclusion criteria

Exclusion criteria: A patient who meets any of the following criteria will be excluded from participation in this study: 1. Heart transplantation 2. Repair of complex congenital abnormalities 3. 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 4. Known hypersensitivity or other severe reaction to any component of the IMP 5. 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) 6. Patients unable to stop treatment by vitamin K antagonists 3-5 days before surgery to obtain an international normalized ratio (INR) 38.5°C and white blood cell count >11/mm3) 19. Active endocarditis 20. Emergency surgery, patients in cardiogenic shock, or expected mortality within 24 hours of surgery 21. Pre-existing thrombocytopenia with platelet count < 150 000/ mm3

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to evaluate the efficacy of FGTW in combination with Standard of care in reducing the need for allogeneic transfusions within the first 24 hours after randomization in complex cardiac surgery patients. ;Secondary Objective: - To evaluate the efficacy associated with the use of FGTW versus Placebo in reducing the number and volume of RBC, FFP, and platelet concentrate transfusions in the 24 hours after randomization until hospital discharge - To evaluate the efficacy associated with the use of FGTW versus Placebo in reducing the blood drainage volume within 12 hours after randomization - To evaluate the number of patients with total avoidance of allogeneic transfusions after randomization - To evaluate the safety of FGTW - To evaluate the impact of FGTW on mortality and surgical morbidity - To evaluate the duration of hospitalization in both treatment arms - To evaluate the length of stay in ICU in both treatment arms;Primary end point(s): Primary efficacy endpoint The primary efficacy endpoint is the number of units of allogeneic blood products (RBC plus FFP plus platelet concentrate) given to patients between randomization and 24 hours thereafter. ;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated 24 hours after randomization.	—

Measure

Time frame

Main Objective: The primary objective of the study is to evaluate the efficacy of FGTW in combination with Standard of care in reducing the need for allogeneic transfusions within the first 24 hours after randomization in complex cardiac surgery patients. ;Secondary Objective: - To evaluate the efficacy associated with the use of FGTW versus Placebo in reducing the number and volume of RBC, FFP, and platelet concentrate transfusions in the 24 hours after randomization until hospital discharge - To evaluate the efficacy associated with the use of FGTW versus Placebo in reducing the blood drainage volume within 12 hours after randomization - To evaluate the number of patients with total avoidance of allogeneic transfusions after randomization - To evaluate the safety of FGTW - To evaluate the impact of FGTW on mortality and surgical morbidity - To evaluate the duration of hospitalization in both treatment arms - To evaluate the length of stay in ICU in both treatment arms;Primary end point(s): Primary efficacy endpoint The primary efficacy endpoint is the number of units of allogeneic blood products (RBC plus FFP plus platelet concentrate) given to patients between randomization and 24 hours thereafter. ;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated 24 hours after randomization.

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Secondary

Measure	Time frame
Secondary end point(s): The secondary efficacy endpoints are defined as follows: 1. Blood drainage volume within 12 hours after randomization 2. Percentage of patients with total avoidance of allogeneic transfusions within 24 hours after randomization 3. Number of transfusion units infused between 24 hours after randomization and the hospital discharge for each class of allogeneic blood product (RBC, FFP, and platelet concentrate) 4. Volume of transfusion units infused between 24 hours after randomization and the hospital discharge for each class of allogeneic blood product (RBC, FFP, and platelet concentrate) 5. Number of pre-donated autologous RBC concentrate units, RBC concentrate prepared by cell-saver, colloids, and crystalloids after randomization 6. Mortality at 24 hours, 7 days, and 30 days after randomization 7. Percentage of patients with each surgical morbidity at 24 hours, 7 days, and 30 days after randomization (see Section 9.2.8) 8. Percentage of patients with post-surgery stage 1 AKI (with increase in creatinine by >50% from baseline until hospital discharge) 9. Percentage of patients with surgical re-exploration for bleeding within 24 hours after randomization 10. Percentage of patients with fibrinogen concentration below the LLN from visit 2 to visit 5 11. Percentage of patients receiving aPCCs, rFVIIa, cryoprecipitate or additional FC as rescue therapy within 24 hours after randomization 12. Duration of hospitalization 13. Length of stay in ICU;Timepoint(s) of evaluation of this end point: The timepoints for the secondary end points listed under E.5.2 are as follows: 1. Within 12h after randomization 2. Within 24h after randomization 3. Between 24h after randomization and the hospital discharge for each class of allogeneic blood product (RBC, FFP, and platelet concentrate) 4. Between 24h after randomization and the hospital discharge for each class of allogeneic blood product (RBC, FFP, and platelet concentrate) 5. After randomization 6 & 7. At 24h	—

Measure

Time frame

Secondary end point(s): The secondary efficacy endpoints are defined as follows: 1. Blood drainage volume within 12 hours after randomization 2. Percentage of patients with total avoidance of allogeneic transfusions within 24 hours after randomization 3. Number of transfusion units infused between 24 hours after randomization and the hospital discharge for each class of allogeneic blood product (RBC, FFP, and platelet concentrate) 4. Volume of transfusion units infused between 24 hours after randomization and the hospital discharge for each class of allogeneic blood product (RBC, FFP, and platelet concentrate) 5. Number of pre-donated autologous RBC concentrate units, RBC concentrate prepared by cell-saver, colloids, and crystalloids after randomization 6. Mortality at 24 hours, 7 days, and 30 days after randomization 7. Percentage of patients with each surgical morbidity at 24 hours, 7 days, and 30 days after randomization (see Section 9.2.8) 8. Percentage of patients with post-surgery stage 1 AKI (with increase in creatinine by >50% from baseline until hospital discharge) 9. Percentage of patients with surgical re-exploration for bleeding within 24 hours after randomization 10. Percentage of patients with fibrinogen concentration below the LLN from visit 2 to visit 5 11. Percentage of patients receiving aPCCs, rFVIIa, cryoprecipitate or additional FC as rescue therapy within 24 hours after randomization 12. Duration of hospitalization 13. Length of stay in ICU;Timepoint(s) of evaluation of this end point: The timepoints for the secondary end points listed under E.5.2 are as follows: 1. Within 12h after randomization 2. Within 24h after randomization 3. Between 24h after randomization and the hospital discharge for each class of allogeneic blood product (RBC, FFP, and platelet concentrate) 4. Between 24h after randomization and the hospital discharge for each class of allogeneic blood product (RBC, FFP, and platelet concentrate) 5. After randomization 6 & 7. At 24h

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Countries

Germany, Italy, Spain, Sweden, United Kingdom

Contacts

Public ContactClinical Trial information desk

LFB BIOTECHNOLOGIES

+33169 82 70 10

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026