TRANEXAMIC ACID IN PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY IN A BRAZILIAN REFERENCE ORTHOPEDIC CENTER: A RANDOMIZED CONTROLLED TRIAL

Phase 4CompletedNCT03019198

Instituto Nacional de Traumatologia e Ortopedia256 enrolled

Overview

This study aims to analyze the efficacy of intravenous tranexamic acid (TXA) in patients undergoing total hip arthroplasty (THA).

This was a prospective, experimental, randomized, controlled study of 308 consecutive patients who underwent primary THA from December 2013 to March 2014. 256 volunteers remained in the study, 128 were treated 15 mg/kg intravenous bolus of TXA and 128 did not receive the medication. Participants were followed up at 3 weeks, 3 months, 6 months, 1 year, and then annually after surgery. The use of TXA resulted in lesser reduction in hemoglobin and hematocrit levels, reduced blood loss, blood transfusion rate, volume of blood products, and stay length even in risk factor patients. TXA protects risk factor patients against intra and postoperative bleeding and reduces transfusion rates.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

256

Conditions

Blood Loss, Surgical Tranexamic Acid Adverse Reaction Hip Replacement

Interventions

Tranexamic Acid Injectable SolutionDRUG

Intravenous 15 mg per kilogram tranexamic acid

Placebo - ConcentrateDRUG

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Locations (1)

Instituto Nacional de Traumatologia e Ortopedia

Rio de Janeiro, Rio de Janeiro, Brazil

Outcomes

Primary Outcomes

Hemoglobin drop

Time frame: 24 hours post operative

Hematocrit drop

Time frame: 24 hours post operative

Blood transfusion rate

Time frame: 5 days

Operative blood loss

Time frame: 24 hours post operative

Secondary Outcomes

Length of stay in hospital

Time frame: 7 days

Systemic adverse events

Time frame: 1 year

Thromboembolic efects

Time frame: 1 year

Data from ClinicalTrials.gov

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