Clinical trial NCT06903299: Prospective Investigation of Intra-Articular Tranexamic Acid Use in Elective Hip Arthroplasty
Official title: Utilisation of Tranexamic Acid in Elective Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Blood Loss
Hemoglobin Change
Blood Transfusion
Heterotopic Ossification
Lead sponsor: St. Anne's University Hospital Brno, Czech Republic
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* Elective hip replacement

Exclusion Criteria:

* Traumatic hip replacement indication

Primary outcomes:
measure: Postoperative Blood Loss
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: Hemoglobin Change
timeFrame: Baseline, 24 hours, and 48 hours postoperatively
measure: Incidence of Heterotopic Ossification
timeFrame: 1 year postoperatively
measure: Incidence of Postoperative Complications
timeFrame: Up to 30 days postoperatively
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: First Department of Orthopaedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia
state: Czechia
Study officials:
References: