Efficay of fibrinogen in liver transplantation

Impact of two thrombelastography-guided strategies of fibrinogen correction on blood product requirements in liver transplantation: a multicenter, randomized trial. TROMBOFIB trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002510-13-ES

Enrollment

176

Registered

2018-08-07

Start date

2018-09-28

Completion date

Unknown

Last updated

2022-05-09

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

Conditions

Liver transplantation is a special risk situation for acute and severe bleeding determined by the complexity of the surgical procedure and by the alteration of haemostasis and coagulation factors, especially fibrinogen, present in the patient affected by a terminal hepatopathy. MedDRA version: 20.0 Level: LLT Classification code 10024716 Term: Liver transplantation System Organ Class: 100000004865

Interventions

Trade Name: RIASTAP Pharmaceutical Form: Solution for infusion INN or Proposed INN: Human fibrinogen Other descriptive name: FIBRINOGEN Trade Name: RIASTAP Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult men and women (=18 years old) - Being a candidate for an orthotopic liver transplant - To have granted the Informed Consent to participate in the study - Final inclusion criteria: Preoperative hemoglobin =65 years) yes F.1.3.1 Number of subjects for this age range 18

Exclusion criteria

Exclusion criteria: Clinical exclusion criteria: preoperative hemoglobin> 130 g/L or any of the following clinical situations: - Familial amyloid polyneuropathy - Hepatic Polycystosis - Live donor receptor - Receiver of donor in asystole, Maastricht type 2 - Acute / subacute liver failure - Retransplantation in acute phase (first transplant in the same hospitalization) - Pregnancy and lactation. - Age less than 18 years

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that the correction of A10FIBTEM values ??by administering fibrinogen up to an A10FIBTEM value of 11 mm is obtained, reduces the administration of packed red blood cells during the transplant procedure and in the first 24 subsequent, in comparison with the administration of fibrinogen up to obtain a value of A10FIBTEM of 8 mm (considered this value as the minimum value required in standard practice).;Secondary Objective: Demonstrate that the correction of A10FIBTEM values ??by administration of fibrinogen to obtain a value of A10FIBTEM of 11 mm compared to the administration of fibrinogen to obtain an A10FIBTEM value of 8mm: 1. Reduces the additional administration of all blood derivatives: plasma, fibrinogen, prothrombin complex, tranexamic acid 2. Decreases acute kidney damage according to KDIGO criteria at one week and 90 days post-transplant 3. Decreases the hours of mechanical ventilation in the postoperative period. 4. Decreases postoperative complications according to the Clavien-Dindo classification. 5. Does not increase thrombotic events in the hepatic graft or in the patient in the first 90 days of the transplant. 6. It does not increase the reinterventions due to hemorrhage, retransplantation, or mortality in the first 90 days of the transplant.;Primary end point(s): The percentage of patients that require concentrates;Timepoint(s) of evaluation of this end point: During the intraoperative and in the 24 hours post surgery	—

Measure

Time frame

Main Objective: To demonstrate that the correction of A10FIBTEM values ??by administering fibrinogen up to an A10FIBTEM value of 11 mm is obtained, reduces the administration of packed red blood cells during the transplant procedure and in the first 24 subsequent, in comparison with the administration of fibrinogen up to obtain a value of A10FIBTEM of 8 mm (considered this value as the minimum value required in standard practice).;Secondary Objective: Demonstrate that the correction of A10FIBTEM values ??by administration of fibrinogen to obtain a value of A10FIBTEM of 11 mm compared to the administration of fibrinogen to obtain an A10FIBTEM value of 8mm: 1. Reduces the additional administration of all blood derivatives: plasma, fibrinogen, prothrombin complex, tranexamic acid 2. Decreases acute kidney damage according to KDIGO criteria at one week and 90 days post-transplant 3. Decreases the hours of mechanical ventilation in the postoperative period. 4. Decreases postoperative complications according to the Clavien-Dindo classification. 5. Does not increase thrombotic events in the hepatic graft or in the patient in the first 90 days of the transplant. 6. It does not increase the reinterventions due to hemorrhage, retransplantation, or mortality in the first 90 days of the transplant.;Primary end point(s): The percentage of patients that require concentrates;Timepoint(s) of evaluation of this end point: During the intraoperative and in the 24 hours post surgery

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Secondary

Measure	Time frame
Secondary end point(s): 1. All blood products administered during the intraoperative period and the first 24 hours postoperatively. They will be considered in absolute values ??and percentages. 2. Measurement of intraoperative bleeding by the sum of losses per aspirator plus gauze weight. 3. Thrombotic events in the graft or in the patient within 90 days after liver transplantation 4. Incidence of acute kidney injury assessed by the KDIGO criteria at 90 days after transplantation 5. Days (number of hours) of mechanical ventilation in the postoperative period 6. Incidence of postoperative complications evaluated by Clavien Dindo classification in the 90 days post-transplant 7. Re-intervention for any cause in the 90 days post transplant 8. Retransplant and Mortality in the 90 days post transplant Security Variables: - Each case of massive transfusion (> 6 red blood cell concentrates), thrombosis or other serious adverse effects will be collected and then will be assessed by an ad hoc committee that includes promoter and PI of each center. Additional Variables: - Demographic data of the patients, blood count, ionogram and renal function, hemostasis and thromboelastometry tests before and after administration of the drug, in the different phases of the procedure.;Timepoint(s) of evaluation of this end point: During the intraoperative and the first 90 days post transplant	—

Measure

Time frame

Secondary end point(s): 1. All blood products administered during the intraoperative period and the first 24 hours postoperatively. They will be considered in absolute values ??and percentages. 2. Measurement of intraoperative bleeding by the sum of losses per aspirator plus gauze weight. 3. Thrombotic events in the graft or in the patient within 90 days after liver transplantation 4. Incidence of acute kidney injury assessed by the KDIGO criteria at 90 days after transplantation 5. Days (number of hours) of mechanical ventilation in the postoperative period 6. Incidence of postoperative complications evaluated by Clavien Dindo classification in the 90 days post-transplant 7. Re-intervention for any cause in the 90 days post transplant 8. Retransplant and Mortality in the 90 days post transplant Security Variables: - Each case of massive transfusion (> 6 red blood cell concentrates), thrombosis or other serious adverse effects will be collected and then will be assessed by an ad hoc committee that includes promoter and PI of each center. Additional Variables: - Demographic data of the patients, blood count, ionogram and renal function, hemostasis and thromboelastometry tests before and after administration of the drug, in the different phases of the procedure.;Timepoint(s) of evaluation of this end point: During the intraoperative and the first 90 days post transplant

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Countries

Spain

Contacts

Public ContactAntoni Sabaté Pes

Antoni Sabaté Pes (Servicio de Anestesiología y Reanimación) del Hospital Universitari de Bellvitge

asabatep@bellvitgehospital.cat34932602487

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 10, 2026