A prospective, randomised controlled trial of the effect of intraosseous injection of tranexamic acid on perioperative blood loss in total hip arthroplasty

Phase 1

• Conditions: End-stage diseases of the hip joint

• Registration Number: ChiCTR2400089028
• Lead Sponsor: The First Affiliated Hospital of Xinjiang Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Age =18 years and gender;<br>(2) Patients diagnosed with end-stage hip diseases such as severe ischaemic necrosis of the femoral head, osteoarthritis of the hip, and developmental hip dislocation according to the American Academy of Orthopaedic Surgeons treatment guidelines.<br>(3) Undergoing initial unilateral total hip arthroplasty;<br>(4) Voluntary and signed informed consent.

Exclusion Criteria

(1) Hypersensitivity to tranexamic acid;<br>(2) Previous history of thromboembolism (including lower extremity deep vein thromboembolism, pulmonary embolism, cerebral infarction, transient ischaemic attack, myocardial infarction or angina attack within 6 months);<br>(3) Progressive renal insufficiency (stage 4 and above) or glomerular filtration rate less than 30 ml/min;<br>(4) Congenital or acquired coagulation disorders;<br>(5) Prolonged use of anticoagulants or antiplatelet agents for other medical conditions (with the exception of routine perioperative anticoagulation by receiving a single subcutaneous injection of low molecular heparin sodium 40mg 12 hours prior to surgery and 12 hours postoperatively);<br>(6) Preoperative assessment of American Society of Anaesthesiologists (ASA) level 4<br>(7) Preoperative prothrombin time (PT) international normalised ratio (INR) >1.4. <br>(8) Needing radiotherapy or chemotherapy for oncological diseases;<br>(9) Severe immunodeficiency diseases (e.g. stage 3 HIV, sickle cell anaemia, splenectomy, etc.)<br>(10) Previous history of substance abuse;<br>(11) Use of immunosuppressive drugs for bone marrow or other grafts;<br>(12) Pregnant, maternal and breastfeeding women;<br>(13) Patients with acquired visual defects;<br>(14) Patients with a history of convulsions;<br>(15) Participating in other clinical trials;<br>(16) Persons who, in the opinion of the investigator, are otherwise unsuitable for clinical trials.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative haemoglobin reduction;

Secondary Outcome Measures

Name	Time	Method
Postoperative blood loss;Postoperative blood transfusion rate, volume;Length of postoperative hospital stay;Changes in the amount of drainage in the operative area;Incidence of postoperative lower limb venous thrombosis;Measurement of inflammatory markers in peripheral blood;