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

NCT ID: NCT04405518

Last Updated: 2021-11-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-17
• Study Completion Date: 2022-10-31

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.

Detailed Description

A total of 176 patients will be included (88 per group) and each center can not include more than 40% of the sample to avoid bias.

Blood samples will be analyzed at different times of the surgical intervention by an electronic device called thromboelastogram. It evaluates the blood clot characteristics and, depending on the results, assesses the need to correct values by the administration of fibrinogen or platelets.

One of the coagulation parameter evaluated and corrected by thromboelastogram is called A10FIBTEM. In a previous study, the investigators have seen that maintaining some specific ranges in the A10FIBTEM, results in a decrease of the use of blood products. That's why the investigators have created 2 groups:

• The control group will be corrected up to a value of A10FIBTEM = 8mm.
• The intervention group will be corrected up to a value of A10FIBTEM = 11mm.

Subsequently, results between groups will be compared. The investigators have to consider that the drug used in this study (Riastap) is an authorized and commercial drug.

The main objective is to demonstrate that the administration of fibrinogen in the intervention group compared to the control group changes the administration of red blood cells pack during the liver transplant and in the first 24 hours after.

Secondary objectives consist in demonstrate that in the intervention group, there is also a change in the administration of other blood products, a change in acute renal damage, a change in hours of mechanical ventilation, no changes in thrombotic events in the hepatic graft or in the patient in the first 90 days of the liver transplant and no changes in re operations, re-transplantation, or mortality during the first 90 days of the liver transplant, compared to the control group.

Conditions

Fibrin Blood Clot

Keywords

fibrinogen; red blood cell pack transfusion; orthotopic liver transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Formula: 8mm - A10FIBTEM registered in mm) x 1.1 = fibrinogen dose required

Group Type: ACTIVE_COMPARATOR

Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]

Intervention Type: 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.

intervention 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.

Formula: 11mm - A10FIBTEM registered in mm) x 1.1 = fibrinogen dose required

Group Type: EXPERIMENTAL

Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]

Intervention Type: 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.

Interventions

Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antoni Sabaté Pes

OTHER

Sponsor Role: lead

Responsible Party

Antoni Sabaté Pes

Head of Anesthesiology and Reanimation Department; MD; PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marta Caballero

Role: PRINCIPAL_INVESTIGATOR

Bellvitge University Hospital

Josep Beltran

Role: PRINCIPAL_INVESTIGATOR

Clinic Hospital, Barcelona

Rosa Gutierrez

Role: PRINCIPAL_INVESTIGATOR

Cruces Hospital, Bilbao

Locations

Bellvitge Universitary Hospital

L'Hospitalet de Llobregat, Barcelone, Spain

Cruces Hospital

Bilbao, Vizcaya, Spain

Clinic Hospital

Barcelona, , Spain

Countries

Spain

Other Identifiers

2018-002510-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TROMBOFIBtrial

Identifier Type: -

Identifier Source: org_study_id