First Department of Orthopaedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia
Brno, Czechia, 62700
NCT Number: NCT06903299
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.
This study is active but is not currently recruiting participants.
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Observational
Brno, Czechia, 62700
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intra-articular Tranexamic acid application during THA and evaluation of postoperative blood losses, hemoglobin decline and associated blood transfusion, heterotopic ossification and other parameters.
Time frame: 48 hours postoperatively
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.
Time frame: Baseline, 24 hours, and 48 hours postoperatively
Change in hemoglobin levels (g/dL) from preoperative baseline to 24 and 48 hours postoperatively. Change from baseline.
Time frame: 1 year postoperatively
Number of patients developing heterotopic ossification, assessed using radiographs at 6 weeks and 3 months postoperatively.
Time frame: Up to 30 days postoperatively
Number of patients experiencing complications such as deep vein thrombosis (DVT), pulmonary embolism (PE), wound infections, and other adverse events.
St. Anne's University Hospital Brno, Czech Republic
Other
Utilisation of Tranexamic Acid in Elective Hip Arthroplasty
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