Osteoarthritis, Total Knee Arthroplasty
Conditions
Interventions
Treatment group 1:Tranexamic acid + absorbable hemostatic gel
Treatment group 2:absorbable hemostatic gel
Treatment group 3:Tranexamic acid
Control group:Without the use of tranexamic acid or absorbable hemostatic gel
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–75 years; 2. Preoperative diagnosis of primary osteoarthritis (Kellgren-Lawrence grade III–IV); 3. Scheduled for unilateral primary TKA; 4. Preoperative Hb >= 120 g/L (males) or >= 110 g/L (females); 5. American Society of Anesthesiologists (ASA) classification I–III; 6. Informed consent obtained from the patient and family members, with the informed consent form signed.
Exclusion criteria
Exclusion criteria: 1. Allergy to any component of TXA or fluid gelatin; 2. Preoperative coagulation disorders (PT > 16 seconds, APTT > 45 seconds); 3. History of DVT or PE, or long-term use of anticoagulants (e.g., warfarin, rivaroxaban); 4. Impaired liver or kidney function (ALT/AST > 2 times the upper limit of normal, serum creatinine > 133 µmol/L); 5. Hematological disorders (e.g., thrombocytopenia, hemophilia); 6. History of active bleeding or surgery within 3 months prior to the procedure; 7. Pregnant or breastfeeding women; 8. Concurrent severe cardiovascular or cerebrovascular disease (e.g., history of myocardial infarction within the past 6 months).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total perioperative blood loss (overt and occult blood loss);Postoperative Blood Transfusion Status (Number of Recipients, Volume Transfused, Type of Blood Transfused); | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematological parameters: Decrease in hemoglobin levels on postoperative days 1, 2, and 3; decrease in hematocrit levels;Fibrinolytic Markers: D-dimer and fibrin degradation products (FDP) on postoperative days 1–3;Inflammatory markers: Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), interleukin-6 (IL-6) on postoperative days 1-3;Postoperative Joint Function Recovery Indicators;Safety-related secondary endpoints: Incidence of venous thromboembolic events (DVT, PE) Incidence of serious adverse events Incidence of TXA-related adverse reactions Incidence of local hemostatic material-related adverse reactions Abnormalities in complete blood count and liver/kidney function parameters; | — |
Countries
Chia
Contacts
Public ContactZeng Yi
West China Hospital, Sichuan University
Outcome results
None listed