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

Antoni Sabaté Pes

Status and phase: Unknown; Phase 4

Conditions: Fibrin Blood Clot

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04405518

2018-002510-13 (EudraCT Number)

TROMBOFIBtrial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 188 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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188 participants in 2 patient groups

Control group

Active Comparator group

Description:

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

Treatment:

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

intervention group

Experimental group

Description:

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

Treatment:

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