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Study of Administration of Tranexamic Acid or Placebo on Bleeding in Adult Patients in Surgery for Liver Transplantation

Study on the Administration of Tranexamic Acid or Placebo on the Rate of Perioperative Bleeding in Adult Patients Undergoing Liver Transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3jwv5kh
Enrollment
Unknown
Registered
2021-05-27
Start date
2021-06-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Coagulopathy

Interventions

The study will consist of a total sample of 140 patients who will undergo liver transplant surgery. Of this total of patients, half of them, that is, 70 patients, will be placed in Group I (placebo) w
D68.9

Sponsors

Hospital de Clinicas de Porto Alegre
Lead Sponsor
Santa Casa de Misericórdia de Porto Alegre
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Only adult ASA III to IV patients, 18 to 70 years old, scheduled for liver transplantation at the Hospital de Clínicas de Porto Alegre, Santa Casa de Porto Alegre and Hospital das Clínicas Faculty of Medicine University of São Paulo.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Evaluate the prevention efficacy of tranexamic acid intravenously in relation to placebo (control - saline) on bleeding in the intraoperative and immediate postoperative (24 hours) in patients undergoing orthotopic liver transplantation.

Secondary

MeasureTime frame
Evaluate the efficacy of tranexamic acid intravenously in relation to placebo (control - saline) on the transfusion rate of blood products in the perioperative period (24 hours) in patients undergoing orthotopic liver transplantation.;Evaluate the efficacy of tranexamic acid intravenously in relation to placebo (control - saline) on the rate of fluid administration in the perioperative period (24 hours) in patients undergoing orthotopic liver transplantation.;Evaluate the effects of tranexamic acid intravenously in relation to placebo (control - saline) on the incidence of thromboembolic events in the perioperative period (up to 30 days) in patients undergoing orthotopic liver transplantation.;Assess the incidence of potential adverse perioperative effects of tranexamic acid intravenously in relation to placebo (control - saline) (up to 30 days) in patients undergoing orthotopic liver transplantation.;Evaluate the effects of tranexamic acid intravenously in relation to placebo (control - saline) on hemodynamic parameters in the perioperative period (24 hours) in patients undergoing orthotopic liver transplantation.;Assess the effects of tranexamic acid intravenously in relation to placebo (control - saline) on perioperative metabolic and gasometric parameters (24 hours) in patients undergoing orthotopic liver transplantation.;Evaluate the efficacy of tranexamic acid intravenously in relation to placebo (control - saline) on the mortality rate (up to 30 days) in patients undergoing orthotopic liver transplantation.;Evaluate the efficacy of tranexamic acid intravenously in relation to placebo (control - saline) on the transfusion rate of blood components in the perioperative period (24 hours) in patients undergoing orthotopic liver transplantation.

Countries

Brazil

Contacts

Public ContactEduarda Martinelli
eduardaschutzmartinelli@gmail.com+55-051-999998859

Outcome results

None listed

Source: REBEC (via WHO ICTRP)