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

Utilisation of Tranexamic Acid in Elective Hip Arthroplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06903299
Enrollment
1000
Registered
2025-03-30
Start date
2023-01-01
Completion date
2026-12-31
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Loss, Blood Transfusion, Hemoglobin Change, Heterotopic Ossification

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.

Detailed description

This prospective, parallel-group clinical study was conducted at the First Department of Orthopaedic Surgery, St. Anne's University Hospital and the Faculty of Medicine, Masaryk University, Brno, Czech Republic. Patient recruitment and prospective data collection were performed from January 1, 2023, to December 31, 2025. The study was designed to evaluate whether the addition of intra-articular tranexamic acid (TXA) to standard intravenous TXA administration improves perioperative blood-management outcomes in patients undergoing elective primary total hip arthroplasty (THA). Eligible patients undergoing elective THA were allocated before surgery to one of two parallel treatment groups. Patients undergoing arthroplasty for traumatic indications were excluded. All procedures were performed under spinal anesthesia using an anterolateral Watson-Jones approach. All patients received 1 g of intravenous TXA before skin incision. In the intravenous-only group, no additional local TXA was administered. In the combined-treatment group, patients received an additional 2 g of TXA diluted in 10 mL of saline, applied intra-articularly around the implanted prosthesis after definitive component implantation, completion of surgical haemostasis, and drying of the operative field, immediately before closure of the fascia lata. Standardized perioperative management was used in both groups. Meticulous electrocautery haemostasis was performed, and a single Redon suction drain was placed in the operated hip and removed 24 hours after surgery. Patients received perioperative thromboprophylaxis with low-molecular-weight heparin according to the institutional protocol. The principal objective of the study was to assess the effect of additional intra-articular TXA on perioperative blood loss and transfusion requirements. Perioperative outcomes included postoperative drainage volume, changes in haemoglobin concentration, red blood cell transfusion requirements, and length of hospital stay. Haemoglobin concentration was recorded preoperatively, on the day of surgery, and on postoperative day 1. Changes in haemoglobin concentration were evaluated from the preoperative value to the day of surgery and from the preoperative value to postoperative day 1. Red blood cell transfusion requirements were assessed both as the proportion of patients requiring transfusion and according to the number of transfused units. Postoperative wound-related and medical complications were also prospectively evaluated. These included persistent wound leakage, requirement for single-use negative-pressure wound therapy, debridement with antibiotics and implant retention (DAIR), implant explantation, and clinically diagnosed thromboembolic complications. Surgical wounds were routinely assessed during the postoperative period, and persistent or progressive wound complications were treated according to the institutional protocol. The study was intended to determine whether combined intravenous and intra-articular administration of TXA provides additional haemostatic benefit compared with intravenous TXA alone while maintaining an acceptable postoperative safety profile in patients undergoing elective primary THA.

Interventions

DRUGIntra-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.

Sponsors

St. Anne's University Hospital Brno, Czech Republic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

Inclusion criteria

* Elective hip replacement

Exclusion criteria

* Traumatic hip replacement indication

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Blood Loss48 hours postoperativelyTotal measured blood loss (in mL) within the first 24 to 48 hours after total hip arthroplasty (THA), calculated from surgical drains and hemoglobin change.

Secondary

MeasureTime frameDescription
Hemoglobin ChangeBaseline, 24 hours, and 48 hours postoperativelyChange in hemoglobin levels (g/dL) from preoperative baseline to 24 and 48 hours postoperatively. Change from baseline.
Incidence of Heterotopic Ossification1 year postoperativelyNumber of patients developing heterotopic ossification, assessed using radiographs at 6 weeks and 3 months postoperatively.
Incidence of Postoperative ComplicationsUp to 30 days postoperativelyNumber of patients experiencing complications such as deep vein thrombosis (DVT), pulmonary embolism (PE), wound infections, and other adverse events.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026