Status:
UNKNOWN
The Effects of Tranexamic Acid or Placebo on Perioperative Bleeding in Adults Undergoing Liver Transplantation.
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Collaborating Sponsors:
University of Sao Paulo
Santa Casa de Porto Alegre
Conditions:
Hemorrhage
Eligibility:
All Genders
18-70 years
Phase:
NA
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 increas...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Adult patients, ASA III to IV (18 to 70 years), scheduled for orthotopic liver transplantation.
Exclusion
- 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.
Key Trial Info
Start Date :
August 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2023
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04753151
Start Date
August 11 2021
End Date
July 30 2023
Last Update
August 25 2021
Active Locations (1)
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1
Andre Prato Schmidt
Porto Alegre, Rio Grande do Sul, Brazil, 90035903