NCT06903299

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

Utilisation of Tranexamic Acid in Elective Hip Arthroplasty

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: St. Anne's University Hospital Brno, Czech Republic · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-03-30
• Last updated: 2025-04-04

Locations

1 site across 1 country: Czechia