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

NCT06903299 | Recruiting

• 1 other identifier: 83V/2022 - AM
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Loss; Hemoglobin Change; Blood Transfusion; Heterotopic Ossification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hemoglobin Change

  Baseline, 24 hours, and 48 hours postoperatively

• Incidence of Heterotopic Ossification

  1 year postoperatively

• Incidence of Postoperative Complications

  Up to 30 days postoperatively

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Elective hip replacement

You may not qualify if:

• Traumatic hip replacement indication

Sponsors & Collaborators

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

Study Sites (1)

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

Brno, Czechia, 62700, Czechia

RECRUITING

MeSH Terms

Conditions

Hemorrhage; Ossification, Heterotopic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pavel Brančík

CONTACT

+420 728 356 094; pavel.brancik@fnusa.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-01

Locations

CZ (1)