Patients diagnosed with unilateral or bilateral primary hip osteoarthritis, osteonecrosis of the femoral head, or developmental dysplasia of the hip, and who are indicated for surgery
Conditions
Interventions
GroupC:Intravenous injection: As for Group A.
Local injection: Before closing the incision and after suturing the joint capsule, dissolve 1.0 g of TXA in 10 ml of saline solution and inject the entire
GroupA:Intravenous administration: 15 minutes prior to skin incision, dissolve 1.0 g of TXA in 100 ml of normal saline and administer by intravenous drip.
Local injection: Prior to closing the incisio
GroupB:Intravenous injection: As in Group A.
Local injection: Before closing the incision, dissolve 1.0 g of TXA in 10 ml of saline solution
5 ml of this is used for injection around the joint cavity (as in the method for Group A), and the remaining 5 ml is injected into the joint cavity after suturing the joint capsule.
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Adult volunteers with a body mass index (BMI) between 18 and 30 kg/m² (inclusive) and body weight between 50 and 100 kg (inclusive); 2. Patients with a confirmed diagnosis of unilateral or bilateral primary osteoarthritis of the hip, avascular necrosis of the femoral head or congenital hip dysplasia, who meet the surgical criteria; diagnostic criteria may be referred to in the *Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)*; 3.Preoperative laboratory parameters, including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), coagulation function (fibrinogen, D-dimer), hemoglobin, and hematocrit, are all within normal ranges;
Exclusion criteria
Exclusion criteria: 1.History of thromboembolic events, coagulation disorders, cardiovascular or renal diseases, pregnancy or lactation, hematuria, allergy to TXA, or other contraindications; 2.Patients with significant comorbidities classified as American Society of Anesthesiologists (ASA) Physical Status class IV or V, dementia, or inability to comply with the study protocol. 3.Receipt of fresh frozen plasma or other blood products or anticoagulant derivatives that affect coagulation within 24 hours preoperatively. 4.Previous hip surgery (including internal fixation, hip arthroscopy, revision hip arthroplasty, etc.) or prior osteotomy for hip dysplasia. 5.Confirmed coagulopathy (e.g., hemophilia, von Willebrand disease), thrombocytopenia (platelet count < 100 × 10?/L), or ongoing anticoagulant/antiplatelet therapy that cannot be discontinued per protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total blood loss; | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum post-operative decrease in haemoglobin levels;Amount of occult blood loss;Time to first ambulation after surgery;Blood transfusion rate;Postoperative length of hospital stay; | — |
Countries
China
Contacts
Public ContactZang Junting
The First Hospital of Jilin University
Outcome results
None listed