The Effects of Tranexamic Acid or Placebo on Perioperative Bleeding in Adults Undergoing Liver Transplantation.

Summary

Around 230 million major procedures are performed worldwide each year. Postoperative complications after major surgery, especially in solid organ transplants, are associated with a significant increase in costs and mortality. Major bleeding episodes in major surgeries such as liver transplantation are related to a significant impact on morbidity and mortality.

In this multicenter study, we aimed to compare the efficacy of tranexamic acid when compared to placebo, administered after anesthetic induction and in continuous infusion during the procedure, on the rate of intraoperative bleeding in adult patients undergoing liver transplantation. Considering its mechanism of action and its pharmacological and clinical properties, we expect to observe a significant reduction in the bleeding rate and in the need for blood components in the perioperative period of adult patients undergoing orthotopic liver transplantation.

In this study, only adult ASA III to IV patients (18 to 70 years old), scheduled for orthotopic liver transplantation at the Hospital de Clínicas de Porto Alegre, Santa Casa de Porto Alegre and at the Hospital das Clínicas of the University of Sao Paulo will be included. Exclusion criteria consider patients with a history of acute arterial thrombosis or venous thromboembolism (\<1 month), patients with a history of known thrombophilia, Budd-Chiari syndrome, primary biliary cholangitis, primary sclerosing cholangitis, patients with reduced left ventricular function ( ejection fraction \<40%), pulmonary hypertension, preoperative pulmonary edema, or severe preoperative hemodynamic changes requiring the use of vasoactive drugs, planned use of tranexamic acid systemically during surgery, hypersensitivity or known allergy to acid tranexamic, history of seizure disorder, patients who have recently suffered a stroke or myocardial infarction (\<1 month), patients with subarachnoid hemorrhage in the last 30 days and patients previously undergoing cranial neurosurgery.

Major bleeding in this study will be defined as bleeding that results in hemoglobin ≤ 8.0 g / dL and the patient receiving a transfusion of ≥ 1 unit of red blood cells; results in a drop in hemoglobin ≥ 4.0 g / dL and the patient receives a transfusion of ≥ 1 unit of red blood cells; results in the patient receiving a transfusion of ≥ 4 units of red blood cells over a 24-hour period; or bleeding leading to surgical reintervention.

Conditions

• Hemorrhage

Interventions

DRUG

Tranexamic acid

The study will be designed as a prospective, double-blinded clinical trial, compared to placebo (0.9% saline) in combination with conventional treatment. Patients will receive intravenous administration of 10 mg / kg tranexamic acid or placebo (0.9% saline) for 10 minutes in the 20 minutes prior to the estimated skin incision. Right after the skin incision, a maintenance dose of 1 mg / kg / h of tranexamic acid (or equivalent infusion rate of 0.9% saline) will be started, remaining until the end of the suture of the surgical wound.

Sponsors & Collaborators

• University of Sao Paulo

  collaborator OTHER

• Santa Casa de Porto Alegre

  collaborator OTHER

• Hospital de Clinicas de Porto Alegre

  lead OTHER

Principal Investigators

• Andre P Schmidt · Hospital de Clinicas de Porto Alegre

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-11

Primary Completion

2022-12-31

Completion

2023-07-30

Countries

• Brazil

Study Locations