NCT03019198

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Instituto Nacional de Traumatologia e Ortopedia · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Blood Loss, Surgical
• Tranexamic Acid Adverse Reaction
• Hip Replacement

Interventions

Type	Name	Description
DRUG	Tranexamic Acid Injectable Solution	Intravenous 15 mg per kilogram tranexamic acid
DRUG	Placebo - Concentrate

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-03-01
• Completion: 2016-03-01
• First posted: 2017-01-12
• Last updated: 2017-03-09

Locations

1 site across 1 country: Brazil