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

Instituto Nacional de Traumatologia e Ortopedia

Status and phase: Completed; Phase 4

Conditions: Tranexamic Acid Adverse Reaction; Blood Loss, Surgical; Hip Replacement

Treatments: Drug: Tranexamic Acid Injectable Solution; Drug: Placebo - Concentrate

Study type: Interventional

Funder types: Other

Identifiers

NCT03019198

06554913.0.0000.5273

Details and patient eligibility

About

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

Full description

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.

Enrollment: 256 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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256 participants in 2 patient groups, including a placebo group

TXA

Experimental group

Description:

Performed an intravenous bolus administration of 15 mg/kg of TXA to the volunteers after the end of the anesthesia and 15 minutes prior to skin incision.

Treatment:

Drug: Tranexamic Acid Injectable Solution

Control

Placebo Comparator group

Description:

This group underwent the same procedures of the TXA group, excepting the preoperative administration of the medication.

Treatment:

Drug: Placebo - Concentrate