Impact of Two Guided Transfusion Strategies on Blood Product Requirements in Liver Transplantation.

NCT04405518 | Unknown Phase 4 DMC

• 2 other identifiers: TROMBOFIBtrial2018-002510-13
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 3

Brief Summary

It is a national multicentre clinical study, where 3 hospitals are involved: Bellvitge University Hospital, Clinic Hospital of Barcelona and Cruces Hospital of Bilbao). It is a randomized study based on the Hemoglobin value of the patient with a 1:1 ratio, parallel groups, controlled and single blind, in patients undergoing an orthotopic liver transplant, confirming previously that the participants fulfill all the inclusion criteria and none of exclusion.

Conditions

Fibrin Blood Clot

Keywords

fibrinogen; red blood cell pack transfusion; orthotopic liver transplantation

Outcome Measures

Primary Outcomes (1)

• Evaluation of the rate of red blood cell packs transfusion during procedure and in the first 24hours after between groups.

  Demonstrate that the A10FIBTEM correction with the administration of fibrinogen up to an A10FIBTEM value of 11mm, change the administration of red blood cell pack during the procedure and in the first 24 hours after it, comparing to the administration of fibrinogen up to an A10FIBTEM of 8mm.

  Intraoperative and the first 24 hours after surgery.

Secondary Outcomes (6)

• Evaluation of the rate of other blood products between groups.

  Intraoperative and the first 24 hours after surgery.

• Evaluation of the acute kidney injury between groups using the Kidney Disease Improving Global Outcomes scale,the minimum values is 1 and the maximum values is 3, higher scores mean a worse outcome.

  first week after the procedure and until 90 days after the procedure.

• Evaluation of the duration of mechanical ventilation in hours between groups.

  first week after the procedure and until 90 days after the procedure..

• Number of participants with major advers cardiac events (MACE), Number of participants with, any sign of infection, Number of participants with neurological events through study completion

  Until 90 days after the procedure.

• Number of participants with thrombotic events in the hepatic graft measured by ecodoppler assessment; and the number of participants with any other thrombotic events measured by ecodoppler assessment of leg extremity or tomography axial of the lungs

  Until 90 days after procedure

Study Arms (2)

Control group

ACTIVE COMPARATOR

The doses of fibrinogen will be calculated acording to the formula based on previous study (AJT2017), rounded to the higher value according to the presentation format of the drug. Study medication will be stored at the hospital pharmacy. Formula: 8mm - A10FIBTEM registered in mm) x 1.1 = fibrinogen dose required

Drug: Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]

intervention group

EXPERIMENTAL

The doses of fibrinogen will be calculated acording to the formula based on previous study (AJT2017), rounded to the higher value according to the presentation format of the drug. Study medication will be stored at the hospital pharmacy. Formula: 11mm - A10FIBTEM registered in mm) x 1.1 = fibrinogen dose required

Drug: Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]

Interventions

Fibrinogen Concentrate (Human) 1 MG [RiaSTAP] DRUG

The drug used in this study is Riastap, 1g (Fibrinogen). The dose administered will depend on the arm group assigned and in the results of the thromboelastogram during the procedure.

Control group; intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years.
• Candidate to an orthotopic liver trasnplantation.
• Informed consent.
• Preoperative hemoglobine \</= 130 g/L

You may not qualify if:

• Preoperative hemoglobin\> 130 g / L
• Familial amyloid polyneuropathy
• Polycystosis hepatic
• Living donor liver transplant
• Uncontrolled donor after cardiac death
• Acute / subacute liver failure
• Re-transplant (in the same hospital admission)
• Use of Anticoagulation drugs before transplantation.
• Age \<18 years.
• Pregnancy and lactation.

Sponsors & Collaborators

• Antoni Sabaté Pes: lead

Study Sites (3)

Bellvitge Universitary Hospital

L'Hospitalet de Llobregat, Barcelone, 08907, Spain

Location

Cruces Hospital

Bilbao, Vizcaya, Spain

Location

Clinic Hospital

Barcelona, Spain

Location

Related Publications (1)

• Sabate A, Caballero M, Gutierrez R, Perez L, Vidal J, Llaurado S, Hereu P, Penafiel J, Blasi A. Factors associated with major complications defined by Clavien-Dindo classification 3-5 after liver transplantation: a prospective multicenter cohort study. Front Surg. 2025 Nov 14;12:1648512. doi: 10.3389/fsurg.2025.1648512. eCollection 2025.

  PMID: 41321850 DERIVED

MeSH Terms

Interventions

Fibrinogen

Intervention Hierarchy (Ancestors)

Acute-Phase Proteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Blood Coagulation Factors; Protein Precursors; Biological Factors

Study Officials

• Marta Caballero

  Bellvitge University Hospital

  PRINCIPAL INVESTIGATOR

• Josep Beltran

  Clinic Hospital, Barcelona

  PRINCIPAL INVESTIGATOR

• Rosa Gutierrez

  Cruces Hospital, Bilbao

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Anesthesiology and Reanimation Department; MD; PhD

Model Details: Participants will be randomly divided into a group receiving concentrate of fibrinogen in the different phases of the liver transplant procedure, to achieve * Thromboelastometry value (A10 FIBTEM) of 11mm (study group) or * Thromboelastometry value (A10 FIBTEM) of 8mm (control group) The doses of fibrinogen will be calculated acording to the formula based on previous study (AJT2017), rounded to the higher value according to the presentation format of the drug. Study medication will be stored at the hospital pharmacy.

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: May 28, 2020
• Study Start: June 17, 2019
• Primary Completion: November 2, 2021
• Study Completion: October 31, 2022
• Last Updated: November 26, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)