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

Utilisation of Tranexamic Acid 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Blood Loss; Blood Transfusion; Heterotopic Ossification; Hemoglobin Change
• Intervention / Treatment: Drug: Intra-articular Tranexamic acid application

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Czechia
  • Czechia
    • Brno, Czechia, Czechia, 62700
      • First Department of Orthopaedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients undergoing elective hip replacement in the First Department of Orthopaedic Surgery, St. Anne's University Hospital, Brno, Czechia from 2023 to 2026.

Description

Inclusion Criteria:

• Elective hip replacement

Exclusion Criteria:

• Traumatic hip replacement indication

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Blood Loss	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.	48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Heterotopic Ossification	Number of patients developing heterotopic ossification, assessed using radiographs at 6 weeks and 3 months postoperatively.	1 year postoperatively
Incidence of Postoperative Complications	Number of patients experiencing complications such as deep vein thrombosis (DVT), pulmonary embolism (PE), wound infections, and other adverse events.	Up to 30 days postoperatively
Hemoglobin Change	Change in hemoglobin levels (g/dL) from preoperative baseline to 24 and 48 hours postoperatively. Change from baseline.	Baseline, 24 hours, and 48 hours postoperatively

Collaborators and Investigators

• Sponsor: St. Anne's University Hospital Brno, Czech Republic

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage; Ossification, Heterotopic; Molecular Mechanisms of Pharmacological Action; Antifibrinolytic Agents; Fibrin Modulating Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 83V/2022 - AM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No