The Effects of Tranexamic Acid or Placebo on Perioperative Bleeding in Adults Undergoing Liver Transplantation.
Status:
Recruiting
Trial end date:
2023-07-30
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Collaborators:
Santa Casa de Porto Alegre University of Sao Paulo