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

NCT ID: NCT06903299

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2026-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Intra-articular Tranexamic acid application

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Elective hip replacement

Exclusion Criteria

• Traumatic hip replacement indication

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Anne's University Hospital Brno, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Brno, Czechia, Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Pavel Brančík

Role: CONTACT

pavel.brancik@fnusa.cz

+420 728 356 094

Facility Contacts

Vasileios Apostolopoulos, MUDr., Ph.D.

Role: primary

vasileios.apostolopoulos@fnusa.cz

+420 722101065

Other Identifiers

83V/2022 - AM

Identifier Type: -

Identifier Source: org_study_id