This study aims to analyze the efficacy of intravenous tranexamic acid (TXA) in patients
undergoing total hip arthroplasty (THA).
Drug: Tranexamic Acid Injectable Solution
Drug: Placebo - Concentrate
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Full eligibility criteria for NCT03019198
Ages eligible for Study
Genders eligible for Study
Accepts Healthy Volunteers
Consecutive patients who need total hip replacement were included in the initial sample. There was no age limit or restriction regarding gender for admission to the study.
Patients who underwent previous surgery in the same joint, evidence of joint infection, congenital or acquired coagulopathies, active intravascular coagulation, acute occlusive vasculopathy, hypersensitivity to TXA, chronic use of oral and steroid anticoagulants, history of severe or moderate allergy to plasma transfusion, chronic heart disease, malignant neoplasms and autoimmune diseases, patients who needed bone graft or underwent hip arthroplasty revision surgeries, and who did not consent to participate in the study
All locations for NCT03019198
Instituto Nacional de Traumatologia e Ortopedia
Rio de Janeiro, Brazil, 20940070
View full eligibility
Tris trial is registered with FDA with number: NCT03019198. The sponsor of the trial is Instituto Nacional de Traumatologia e Ortopedia and it is looking for 256 volunteers for the current phase.
Official trial title: TRANEXAMIC ACID IN PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY IN A BRAZILIAN REFERENCE ORTHOPEDIC CENTER: A RANDOMIZED CONTROLLED TRIAL
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