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

Phase 4

Completed

• Conditions: Hip Replacement; Blood Loss, Surgical; Tranexamic Acid Adverse Reaction
• Interventions: Drug: Tranexamic Acid Injectable Solution; Drug: Placebo - Concentrate

• Registration Number: NCT03019198
• Lead Sponsor: Instituto Nacional de Traumatologia e Ortopedia

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2014-03
• Study Completion: 2016-03
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TXA	Tranexamic Acid Injectable Solution	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.
Control	Placebo - Concentrate	This group underwent the same procedures of the TXA group, excepting the preoperative administration of the medication.

Primary Outcome Measures

Name	Time	Method
Blood transfusion rate	5 days
Hemoglobin drop	24 hours post operative
Hematocrit drop	24 hours post operative
Operative blood loss	24 hours post operative

Secondary Outcome Measures

Name	Time	Method
Length of stay in hospital	7 days
Thromboembolic efects	1 year
Systemic adverse events	1 year

Trial Locations

Locations (1)

Instituto Nacional de Traumatologia e Ortopedia; 🇧🇷 Rio de Janeiro, Brazil