Upper urinary tract calculi
Conditions
Interventions
Trial group (LMWH+IPC):Low molecular weight heparin (LMWH) combined with intermittent pneumatic compression (IPC) during perioperative period: subcutaneous injection of LMWH daily (4000 IU for body we
5000 IU for >70 kg
half dose for patients with eGFR 30–60 mL/min/1.73m^2), discontinued 24 hours before surgery, resumed on the day of stable hemostasis postoperatively
IPC initiated within <=2 hours after surgery, continued until discharge or stable ambulation.
Control group (IPC only):Intermittent pneumatic compression (IPC) alone: no prophylactic dose of LMWH used
Sponsors
Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–80 years, either sex; 2. Upper urinary tract calculi confirmed by CT or urinary ultrasonography, scheduled for unilateral or staged unilateral retrograde intrarenal surgery (RIRS); 3. Preoperative Caprini venous thromboembolism risk score =3, including moderate risk 3–4 and high risk =5; 4. ASA physical status I–III and able to tolerate general anesthesia; 5. Platelet count =100×10^9/L, without severe coagulation dysfunction; 6. Normal D-dimer, or elevated D-dimer with deep vein thrombosis excluded by lower-extremity ultrasonography; 7. Able to understand the study, voluntarily sign informed consent, and comply with perioperative lower-extremity venous ultrasonography and other necessary imaging examinations.
Exclusion criteria
Exclusion criteria: 1. Known coagulation disorders, such as hemophilia, platelet count 1.5 times the normal value, fibrinogen =180 mmHg and/or diastolic blood pressure >=110 mmHg; patients whose blood pressure can be controlled below the above range after treatment may be included); 4. Women who are pregnant, lactating, or planning pregnancy; 5. Severe renal insufficiency (eGFR <30 mL·min^-1·1.73 m^-2); 6. Comorbid malignant tumors requiring long-term anticoagulation or chemotherapy; 7. Concurrent participation in other clinical trials; 8. Less than 2 days from admission to surgery, making it impossible to complete at least 2 days of preoperative LMWH administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of perioperative VTE during hospitalization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of BARC grade >=2 bleeding;Benefit-risk ratio of thrombosis and bleeding;Postoperative length of hospital stay;Time to first ambulation;Operative time;Stone-free rate;Readmission related to residual stones;Perioperative dynamic change of D-dimer;Change in EQ-5D score; | — |
Countries
China
Contacts
Public ContactChen Jinbo
Department of Urology, Xiangya Hospital, Central South University
Outcome results
None listed