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NCT Number: NCT06903299

Prospective Investigation of Intra-Articular Tranexamic Acid Use in Elective Hip Arthroplasty

Tranexamic acid (trans-4-aminomethyl cyclohexane carboxylic acid) is an antifibrinolytic substance that chemically belongs to the group of e-carboxylic acids. TXA is a synthetic amino acid derivative of lysine that competitively inhibits the activation of plasminogen to the serine protease, plasmin. TXA is a competitive inhibitor of tissue plasminogen activator, blocking the lysine-binding sites of plasminogen, resulting in inhibition of plasminogen activation and fibrin binding to plasminogen and therefore impairment of fibrinolysis.

Due to its antifibrinolytic effect (reduction of bleeding), TXA has been recently an increasing interest in orthopaedics, especially in elective major joint replacements.

The total hip arthroplasties (ΤΗΑ) are associated with perioperative blood losses exceeding 500 mL. Blood loss volumes are dependent on the chosen surgical approach and technique. Some patients that undergo elective hip replacement receive at least one blood unit in postoperative care. Heterotopic ossification is also a common complication after THA, presented as bone in soft tissue where bone normally does not appear. TXA reduces postoperative blood losses and consequently leads to less frequent blood transfusions. This has an impact on the economic burden for the health care system. Increased blood loss could lead to longer length of stay at the hospital and the connected economic consequences. TXA further reduces the incidence of heterotopic ossification after elective THA.

Objectives:

The aim of this study is to prospectively evaluate postoperative blood losses, hemoglobin decline and associated blood transfusion, heterotopic ossification and other parameters in patients with intraarticular application of Tranexamic acid during THA.

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This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

First Department of Orthopaedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia

Brno, Czechia, 62700

Who can participate

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

Inclusion criteria

  • Elective hip replacement

Exclusion criteria

  • Traumatic hip replacement indication

Treatment and study plan

Intra-articular Tranexamic acid application

Drug

Intra-articular Tranexamic acid application during THA and evaluation of postoperative blood losses, hemoglobin decline and associated blood transfusion, heterotopic ossification and other parameters.

Primary outcomes

  1. Postoperative Blood Loss

    Time frame: 48 hours postoperatively

    Total measured blood loss (in mL) within the first 24 to 48 hours after total hip arthroplasty (THA), calculated from surgical drains and hemoglobin change.

Secondary outcomes

  1. Hemoglobin Change

    Time frame: Baseline, 24 hours, and 48 hours postoperatively

    Change in hemoglobin levels (g/dL) from preoperative baseline to 24 and 48 hours postoperatively. Change from baseline.

  2. Incidence of Heterotopic Ossification

    Time frame: 1 year postoperatively

    Number of patients developing heterotopic ossification, assessed using radiographs at 6 weeks and 3 months postoperatively.

  3. Incidence of Postoperative Complications

    Time frame: Up to 30 days postoperatively

    Number of patients experiencing complications such as deep vein thrombosis (DVT), pulmonary embolism (PE), wound infections, and other adverse events.

Sponsors and collaborators

Lead sponsor

St. Anne's University Hospital Brno, Czech Republic

Other

Registry information

Official study title

Utilisation of Tranexamic Acid in Elective Hip Arthroplasty

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2025
Registry last updated
May 13, 2026

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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