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

NCT04753151 | Unknown

• 1 other identifier: 40693520.8.0000.5327
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hemorrhage; Major bleeding; Liver transplantation; Tranexamic acid; Antifibrinolytic drugs

Outcome Measures

Primary Outcomes (1)

• Incidence of perioperative major bleeding in patients undergoing orthotopic liver transplantation.

  To evaluate the efficacy of tranexamic acid intravenously in relation to placebo (control - saline) on the incidence of major bleeding in the intraoperative and immediate postoperative (24 hours) in patients undergoing orthotopic liver transplantation.

  24 hours

Secondary Outcomes (3)

• Effects of tranexamic acid or placebo on the mortality rate in patients undergoing orthotopic liver transplantation.

  30 days

• Effects of tranexamic acid or placebo on the transfusion rate of blood products in the perioperative period in patients undergoing orthotopic liver transplantation.

  24 hours

• Effects of tranexamic acid or placebo on the rate of fluid administration in the perioperative period in patients undergoing orthotopic liver transplantation.

  24 hours

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

Patients scheduled for liver transplantation and allocated for treatment with tranexamic acid (Group 1).

Drug: Tranexamic acid

Placebo

PLACEBO COMPARATOR

Patients scheduled for liver transplantation and allocated for treatment with placebo (Group 2).

Drug: Tranexamic acid

Interventions

Tranexamic acid DRUG

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.

Placebo; Tranexamic acid

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, ASA III to IV (18 to 70 years), scheduled for orthotopic liver transplantation.

You may not qualify if:

• 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. Patients with chronic dialysis kidney disease or patients in need of a liver-kidney transplant will also be excluded from the study.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• University of Sao Paulo: collaborator
• Santa Casa de Porto Alegre: collaborator

Study Sites (1)

Andre Prato Schmidt

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Andre P Schmidt

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andre P Schmidt, MD, MSc, PhD

CONTACT

+5551996412212; apschmidt@hcpa.edu.br

Eduarda S Martinelli, MD

CONTACT

+555199998859; eduardaschutzmartinelli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The method for blinding the study will be carried out through the use of sealed envelopes and will include the blinding of the assisting anesthesiologists, patients, researchers, evaluators and those responsible for the statistical analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized parallel controlled trial.

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 15, 2021
• Study Start: August 11, 2021
• Primary Completion: December 31, 2022
• Study Completion: July 30, 2023
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)