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A comparative study on prevention of lower extremity deep vein thrombosis after hip/knee replacement using sulfonate and ntrexapparin calcium based on ERAS concept

A comparative study on prevention of lower extremity deep vein thrombosis after hip/knee replacement using sulfonate and ntrexapparin calcium based on ERAS concept

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042205
Enrollment
Unknown
Registered
2021-01-15
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-04-19

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

Conditions

Osteoarthritis

Interventions

Sulfonda liver decanodium group:Sulfodagan-Gui Sodium Injection (Jiangsu Hengrui Company) 2.5mg was injected subcutaneously 12 hours after operation
Natreheparin calcium group:Subcutaneously injected Natreheparin calcium 57 IU/kg 6 hours after operation

Sponsors

Affiliated Hospital of North Sichuan Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who were hospitalized for primary hip or knee arthroplasty for various reasons without contraindications (including total hip arthroplasty, artificial femoral head arthroplasty and total knee arthroplasty); 2. The subjects who signed the written informed consent; 3. Male patients or infertile female patients aged 18-80 years (e.g. postmenopausal women, women after hysterectomy or bilateral tubal ligation) or women who were not pregnant or had no pregnancy plan during the study period; 4. The subjects with normal coagulation function and no blood system diseases had no previous cerebral thrombosis, cerebral infarction and other vascular embolic diseases, and they did not use any anticoagulants within 3 months before the trial; 5. The subjects with preoperative BMI >= 20 had negative DVT in both lower limbs; 6. Before the experiment, the blood index of the patient indicated that the renal function was normal.

Exclusion criteria

Exclusion criteria: Patients meeting any of the following exclusion criteria should be excluded: 1. The influencing factors of low molecular weight heparin (LMWH) application (1) There was a history of severe active haemorrhage (within 3 months); (2) Patients with thrombocytopenia or history of thrombocytopenia (platelet count below 100 x 10^9 / L); (3) Hypersensitivity to heparin, natroparin calcium and pork products; (4) Acute bacterial endocarditis; (5) Congenital or acquired bleeding tendency and disease (within 3 months); (6) Uncontrolled ulcerative or angiodysplastic gastrointestinal diseases; (7) Hemorrhagic cerebrovascular disease or history of brain, spine or ophthalmic surgery within 3 months before randomization; (8) Patients with contraindication of anticoagulant therapy or patients with long-term oral anticoagulant due to previous diseases can not stop taking anticoagulant; (9) 5 times higher than the upper limit of normal value, kidney (muscle liver clearance rate < 30ml / min), abnormal heart function, uncontrolled hypertension and tumor patients; (10) Patients with lower extremity vascular disease; (11) Pregnancy test was positive; 2. Influencing factors related to other reasons (1) In the past 90 days, I have participated in the clinical trials of drugs and instruments for the prevention of DVT; (2) Patients who underwent bilateral joint replacement at the same time; (3) BMI < 20, DVT positive, prothrombin activity < 60%, history of thrombosis, creatinine clearance rate below 50ml / min; (4) Patients with previous history of thrombosis or varicose veins of lower limbs; (5) Patients who refused to participate or had poor compliance due to other reasons.

Design outcomes

Primary

MeasureTime frame
Color ultrasound of lower extremity vessels;

Secondary

MeasureTime frame
Routine blood cell tests;Coagulation function test;

Countries

China

Contacts

Public ContactChen Lu

Affiliated Hospital of North Sichuan Medical College

18057819@qq.com+86 13890871029

Outcome results

None listed

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