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

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Notable Lead sponsor: St. Anne's University Hospital Brno, Czech Republic to St. Anne's University Hospital Brno, Czech Republic Show 6 more changesShow less
    • Primary completion date changed from estimate of Dec 31, 2026 to Dec 31, 2025
    • Trial arms changed: 0 → 2
    • Secondary endpoints: details revised at 1 of 3 entries
    • Study description expanded, about 417 words
    • Site details revised
    • Eligibility criteria expanded, about 2 words
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v3
  3. Minor Secondary endpoints revised (3)v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06903299
Lead Sponsor St. Anne's University Hospital Brno, Czech Republic
Conditions
(from sponsor)
Blood Loss, Hemoglobin Change, Blood Transfusion, Heterotopic Ossification
Related terms Hemorrhage, Ossification, Heterotopic
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov