Effectiveness of different fibrinogen based medicines in improving coagulation

Effectiveness Of Different Fibrinogen Preparations In Restoring Clot Firmness - EDIPO_RE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-001105-40-IT

Enrollment

Registered

2022-10-13

Start date

2023-01-25

Completion date

Unknown

Last updated

2024-10-28

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

Conditions

Postoperative bleeding after cardiac surgery MedDRA version: 20.0 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Name: RIASTAP Product Code: [RIASTAP] Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion INN or Proposed INN: FIBRINOGENO UMANO LIOFILIZZATO CAS Number: 9001-32-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age > 18 years; Absence of known or presumed coagulation diseases from the anamnestic analysis; Cardiac surgery with extracorporeal circulation in election; Complex cardiac surgery (coronary artery bypass + valve; double / triple valve, ascending aorta); Signature of informed consent. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Urgent or emergency cardiac surgery; Known sensitivity to the components of the drugs under study; Participation in other ongoing clinical trials.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the differences between two drugs (RIASTAP and FIBRICLOTTE) in a series of adult patients undergoing complex cardiac surgery with extracorporeal circulation in terms of clots stability;Secondary Objective: To evaluate the differences between two drugs (RIASTAP and FIBRICLOTTE) in a series of adult patients undergoing complex cardiac surgery with extracorporeal circulation in terms of post operative bleeding and incidence of transfusion;Primary end point(s): Concentration of fibrinogen in the blood as a parameter of the amplitude of the MCF clot in the FIBTEM and EXTEM test by ROTEM®, and parameters of the speed and effectiveness of clot formation CT and CFT in the FIBTEM and EXTEM tests;Timepoint(s) of evaluation of this end point: Postoperative bleeding in the first 12 and 24 postoperative hours, incidence of severe bleeding (moderate and higher degree of severity, as defined by UDPB), incidence of transfusion of blood products (RBCs and platelets) in the 12 and 24 postoperative hours	—

Measure

Time frame

Main Objective: To evaluate the differences between two drugs (RIASTAP and FIBRICLOTTE) in a series of adult patients undergoing complex cardiac surgery with extracorporeal circulation in terms of clots stability;Secondary Objective: To evaluate the differences between two drugs (RIASTAP and FIBRICLOTTE) in a series of adult patients undergoing complex cardiac surgery with extracorporeal circulation in terms of post operative bleeding and incidence of transfusion;Primary end point(s): Concentration of fibrinogen in the blood as a parameter of the amplitude of the MCF clot in the FIBTEM and EXTEM test by ROTEM®, and parameters of the speed and effectiveness of clot formation CT and CFT in the FIBTEM and EXTEM tests;Timepoint(s) of evaluation of this end point: Postoperative bleeding in the first 12 and 24 postoperative hours, incidence of severe bleeding (moderate and higher degree of severity, as defined by UDPB), incidence of transfusion of blood products (RBCs and platelets) in the 12 and 24 postoperative hours

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Countries

Italy

Contacts

Public ContactLaboratorio Emostasi e Coagulazione

I.R.C.C.S. POLICLINICO SAN DONATO

ekaterina.baryshnikova@grupposandonato.it0252774754

Outcome results

None listed

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