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Effectiveness and safety of sulfonate in the prevention of venous thromboembolism after hip fracture

Effectiveness and safety of sulfonate in the prevention of venous thromboembolism after hip fracture

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042259
Enrollment
Unknown
Registered
2021-01-17
Start date
2021-01-18
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

Hip fracture

Interventions

experimental group:Sulfonda liver decanodium 2.5mg, subcutaneous injection.
Control group 1:Enoxaparin sodium 4000IU (Sanofi) subcutaneous injection
Control group 2:Oral rivaroxaban 10mg (Bayer)

Sponsors

Affiliated Hospital of North Sichuan Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Unilateral femoral intertrochanteric fracture; 2. Patients >= 60 years old; 3. Internal fixation of fracture is needed; 4. The time between the injury and the operation shall not exceed 72 hours; 5. No history of long-term use of anticoagulants (such as warfarin, aspirin, clopidogrel, etc.); 6. Liver and kidney function is basically normal, no anticoagulant therapy contraindications (absolute contraindications: (1) recent active bleeding and coagulation dysfunction; (2) Osteofascial compartment syndrome; (3) Severe head trauma or acute spinal cord injury; (4) platelet count < 20 x 10^9 / L; (5) Patients with a history of heparin-induced thrombocytopenia. Relative contraindications: (1) Recent history of intracranial hemorrhage and gastrointestinal bleeding;(2) Acute intracranial injury or mass;(3) The platelet count decreased to 20 x 10^9/L~100 x 10^9/L; (4) Rheumatoid retinopathy, with the risk of fundus hemorrhage).

Exclusion criteria

Exclusion criteria: 1. Patients with multiple injuries and complex injuries; 2. Pathological fracture; 3. The patient is less than 60 years old; 4. Patients who cannot tolerate surgery in general; 5. If there are medical diseases that need treatment before surgery, the operation cannot be completed within 72 hours after the injury; 6. Abnormal liver and kidney function; 7. Long-term use of anticoagulant drugs; 8. Patients selected for non-surgical treatment. 9. Patients with deep vein thrombosis found by preoperative lower extremity vascular ultrasound.

Design outcomes

Primary

MeasureTime frame
Incidence of DVT;

Secondary

MeasureTime frame
D - dimer;Incidence of major bleeding;Incidence of symptomatic DVT and non fatal PE;

Countries

China

Contacts

Public ContactJiang Ke

Affiliated Hospital of North Sichuan Medical College

20359251@qq.com+86 18382917277

Outcome results

None listed

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