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Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness (EDIPORE)

Primary Purpose

Hypofibrinogenemia, Surgical Blood Loss, Bleeding

Status

Recruiting

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

FIBRICLOTTE

RiaSTAP

About this trial

This is an interventional diagnostic trial for Hypofibrinogenemia focused on measuring hypofibrinogenemia, cardiac surgery, postoperative bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

IRCCS Policlinico San DonatoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FIBRICLOTTE

RIASTAP

Arm Description

Outcomes

Primary Outcome Measures

FIBTEM MCF (mm)

Fibrinogen contribution to the clot firmness measured by ROTEM device, as maximum clot firmness parameter).

FIBTEM CT and CFT (sec)

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)

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

Amount of postoperative bleeding measured by the cardiac drainages

Incidence of moderate/severe bleeding

Number of cases of moderate or severe bleeding, as defined by the Universal Definition of Perioperative bleeding

Incidence of transfusion

Number of cases requiring the transfusion of red blood cells and platelet concentrates

Full Information

NCT ID

NCT05780125

First Posted

February 22, 2023

Last Updated

March 31, 2023

Sponsor

IRCCS Policlinico S. Donato

1. Study Identification

Unique Protocol Identification Number

NCT05780125

Brief Title

Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness

Acronym

EDIPORE

Official Title

Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 20, 2023 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IRCCS Policlinico S. Donato

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypofibrinogenemia, Surgical Blood Loss, Bleeding, Cardiac Disease, Surgery

Keywords

hypofibrinogenemia, cardiac surgery, postoperative bleeding

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FIBRICLOTTE

Arm Type

Experimental

Arm Title

RIASTAP

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

FIBRICLOTTE

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

RiaSTAP

Intervention Description

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

Primary Outcome Measure Information:

Title

FIBTEM MCF (mm)

Description

Fibrinogen contribution to the clot firmness measured by ROTEM device, as maximum clot firmness parameter).

Time Frame

Within 10 minutes after protamine administration

Title

FIBTEM CT and CFT (sec)

Description

Fibrinogen contribution to the clot firmness measured by ROTEM device, as time required for clot formation (CT, clotting time, and CFT, clot formation time).

Time Frame

Within 10 minutes after protamine administration

Title

EXTEM CT and CFT (sec)

Description

Time required for the overall clot formation on the extrinsic pathway of coagulation ( CT, clotting time, and CFT, clot formation time).

Time Frame

Within 10 minutes after protamine administration

Secondary Outcome Measure Information:

Title

Postoperative bleeding

Description

Amount of postoperative bleeding measured by the cardiac drainages

Time Frame

12 and 24 hours after surgery

Title

Incidence of moderate/severe bleeding

Description

Number of cases of moderate or severe bleeding, as defined by the Universal Definition of Perioperative bleeding

Time Frame

12 hours after surgery

Title

Incidence of transfusion

Description

Number of cases requiring the transfusion of red blood cells and platelet concentrates

Time Frame

12 and 24 hours after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ekaterina Baryshnikova, PhD

Phone

0252774754

Ext

+39

ekaterina.baryshnikova@grupposandonato.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marco Ranucci, MD

Organizational Affiliation

IRCCS Policlinico S. Donato

Official's Role

Principal Investigator

Facility Information:

Facility Name

IRCCS Policlinico San Donato

City

San Donato Milanese

State/Province

ZIP/Postal Code

20097

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ekaterina Baryshnikova, PhD

Phone

0252774754

ekaterina.baryshnikova@grupposandonato.it

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26893405

Citation

Ranucci M, Baryshnikova E. Fibrinogen supplementation after cardiac surgery: insights from the Zero-Plasma trial (ZEPLAST). Br J Anaesth. 2016 May;116(5):618-23. doi: 10.1093/bja/aev539. Epub 2016 Feb 17.

Results Reference

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PubMed Identifier

34368944

Citation

Stolt H, Shams Hakimi C, Singh S, Jeppsson A, Karlsson M. A comparison of the in vitro effects of three fibrinogen concentrates on clot strength in blood samples from cardiac surgery patients. Acta Anaesthesiol Scand. 2021 Nov;65(10):1439-1446. doi: 10.1111/aas.13967. Epub 2021 Sep 1.

Results Reference

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PubMed Identifier

30711263

Citation

Scolletta S, Simioni P, Campagnolo V, Celiento M, Fontanari P, Guadagnucci A, Guarracino F, Haxhiademi D, Paniccia R, Simeone F, Ranucci M; Granducato Research Group. Patient blood management in cardiac surgery: The "Granducato algorithm". Int J Cardiol. 2019 Aug 15;289:37-42. doi: 10.1016/j.ijcard.2019.01.025. Epub 2019 Jan 11.

Results Reference

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PubMed Identifier

34217578

Citation

Tibi P, McClure RS, Huang J, Baker RA, Fitzgerald D, Mazer CD, Stone M, Chu D, Stammers AH, Dickinson T, Shore-Lesserson L, Ferraris V, Firestone S, Kissoon K, Moffatt-Bruce S. STS/SCA/AmSECT/SABM Update to the Clinical Practice Guidelines on Patient Blood Management. J Cardiothorac Vasc Anesth. 2021 Sep;35(9):2569-2591. doi: 10.1053/j.jvca.2021.03.011. Epub 2021 Jun 30. No abstract available.

Results Reference

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PubMed Identifier

24332097

Citation

Dyke C, Aronson S, Dietrich W, Hofmann A, Karkouti K, Levi M, Murphy GJ, Sellke FW, Shore-Lesserson L, von Heymann C, Ranucci M. Universal definition of perioperative bleeding in adult cardiac surgery. J Thorac Cardiovasc Surg. 2014 May;147(5):1458-1463.e1. doi: 10.1016/j.jtcvs.2013.10.070. Epub 2013 Dec 9.

Results Reference

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Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness

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