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Completed

NCT Number: NCT03019198

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

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto Nacional de Traumatologia e Ortopedia

Rio de Janeiro, 20940070, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid Injectable Solution

Drug

Intravenous 15 mg per kilogram tranexamic acid

Other names: Lysteda, Transamin

Placebo - Concentrate

Drug

Primary outcomes

  1. Hemoglobin drop

    Time frame: 24 hours post operative

  2. Hematocrit drop

    Time frame: 24 hours post operative

  3. Blood transfusion rate

    Time frame: 5 days

  4. Operative blood loss

    Time frame: 24 hours post operative

Secondary outcomes

  1. Length of stay in hospital

    Time frame: 7 days

  2. Systemic adverse events

    Time frame: 1 year

  3. Thromboembolic efects

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Traumatologia e Ortopedia

Other Gov

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Jan 12, 2017
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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