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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089028
Enrollment
Unknown
Registered
2024-08-30
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-09-02

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

Conditions

End-stage diseases of the hip joint

Interventions

Intraosseous injection group:All subjects were given intramedullary injections of tranexamic acid at 20 mg/kg according to the patients body weight at the following sites: lateral aspect of the greate
intravenous group:All subjects were given tranexamic acid intravenously at 20 mg/kg based on the patients body weight 0.5 hours before skin incision
Local injection group:Tranexamic acid was administered locally according to the patients body weight (20 mg/kg) before suturing the surgical area.
blank control group:Tranexamic acid is not given

Sponsors

The First Affiliated Hospital of Xinjiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Age =18 years and gender; (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. (3) Undergoing initial unilateral total hip arthroplasty; (4) Voluntary and signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Hypersensitivity to tranexamic acid; (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); (3) Progressive renal insufficiency (stage 4 and above) or glomerular filtration rate less than 30 ml/min; (4) Congenital or acquired coagulation disorders; (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); (6) Preoperative assessment of American Society of Anaesthesiologists (ASA) level 4 (7) Preoperative prothrombin time (PT) international normalised ratio (INR) >1.4. (8) Needing radiotherapy or chemotherapy for oncological diseases; (9) Severe immunodeficiency diseases (e.g. stage 3 HIV, sickle cell anaemia, splenectomy, etc.) (10) Previous history of substance abuse; (11) Use of immunosuppressive drugs for bone marrow or other grafts; (12) Pregnant, maternal and breastfeeding women; (13) Patients with acquired visual defects; (14) Patients with a history of convulsions; (15) Participating in other clinical trials; (16) Persons who, in the opinion of the investigator, are otherwise unsuitable for clinical trials.

Design outcomes

Primary

MeasureTime frame
Postoperative haemoglobin reduction;

Secondary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactCao Li

The First Affiliated Hospital of Xinjiang Medical University

3360901096@qq.com+86 175 9979 1728

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026