EDIPORE: Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness

Sponsor

IRCCS Policlinico S. Donato (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05780125

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Fibrinogen concentrate is produced by different manufacturers using different purification technologies. The products available in Italy are three: RIASTAP (CSL Behring), FIBRYGA (Octapharma), and FIBRICLOTTE (LFB). RIASTAP and FIBRYGA are sold in 1-gram vials, and FIBRICLOTTE - in 1.5 grams vials. A recent in vitro study assessed how these products affected the clot firmness measured by the ROTEM FIBTEM maximum clot firmness (MCF) parameter. In vitro conditions, FIBRICLOTTE was verified to be the most efficient in increasing clot firmness.

The present study is aimed to assess, in a series of patients undergoing cardiac surgery with cardiopulmonary bypass, the hypothesis that the FIBRICLOTTE fibrinogen is superior to the RIASTAP fibrinogen in increasing the FIBTEM MCF parameter in a clinical model of bleeding (postoperative bleeding after complex cardiac surgery).

Condition or Disease	Intervention/Treatment	Phase
Hypofibrinogenemia Surgical Blood Loss Bleeding Cardiac Disease Surgery	Drug: FIBRICLOTTE Drug: RiaSTAP	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FIBRICLOTTE	Drug: FIBRICLOTTE 30 mg/kg of FIBRICLOTTE (rounded up to the nearest 2 or 3 grams) after protamine administration
Active Comparator: RIASTAP	Drug: RiaSTAP 30 mg/kg of RIASTAP (rounded up to the nearest 2 or 3 grams) after protamine administration

Arm

Intervention/Treatment

Experimental: FIBRICLOTTE

Drug: FIBRICLOTTE

30 mg/kg of FIBRICLOTTE (rounded up to the nearest 2 or 3 grams) after protamine administration

Active Comparator: RIASTAP

Drug: RiaSTAP

30 mg/kg of RIASTAP (rounded up to the nearest 2 or 3 grams) after protamine administration

Outcome Measures

Primary Outcome Measures

FIBTEM MCF (mm) [Within 10 minutes after protamine administration]
Fibrinogen contribution to the clot firmness measured by ROTEM device, as maximum clot firmness parameter).
FIBTEM CT and CFT (sec) [Within 10 minutes after protamine administration]
Fibrinogen contribution to the clot firmness measured by ROTEM device, as time required for clot formation (CT, clotting time, and CFT, clot formation time).
EXTEM CT and CFT (sec) [Within 10 minutes after protamine administration]
Time required for the overall clot formation on the extrinsic pathway of coagulation ( CT, clotting time, and CFT, clot formation time).

Secondary Outcome Measures

Postoperative bleeding [12 and 24 hours after surgery]
Amount of postoperative bleeding measured by the cardiac drainages
Incidence of moderate/severe bleeding [12 hours after surgery]
Number of cases of moderate or severe bleeding, as defined by the Universal Definition of Perioperative bleeding
Incidence of transfusion [12 and 24 hours after surgery]
Number of cases requiring the transfusion of red blood cells and platelet concentrates

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

elective cardiac surgery with cardiopulmonary bypass;
complex cardiac surgery (coronary artery bypass graft + valve repair/replacement; double/triple valve repair/replacement; ascendant aorta surgery);
written consent to participate;

Exclusion Criteria:

urgent or emergent cardiac surgery;
known hypersensitivity to the active principle or to one of the excipients of the study drugs;
coagulation disorders, known or presumable from anamnesis;
known hepatopathy;
known risk of thrombosis or disseminated intravascular coagulation;
participation in another clinical study where an experimental product has been administered within 30 days from the day of the inclusion in the study;
whatever clinical condition that, in the opinion of the investigator, makes the patients not suitable to the experimentation.