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Efficacy and safety of fondaparinux in prevention of deep venous thrombosis after total knee arthroplasty study

Efficacy and safety of fondaparinux in prevention of deep venous thrombosis after total knee arthroplasty study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082184
Enrollment
Unknown
Registered
2024-03-22
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-03-25

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

Conditions

Total knee arthroplasty

Interventions

Fondaparinux (FPX) group:Fondaparinux Sodium Injection
LMWH group:Enoxaparin Sodium Injection

Sponsors

The Affiliated Hospital of Panzhihua University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 76 Years

Inclusion criteria

Inclusion criteria: (1) All patients were negative for lower extremity DVT by ultrasound examination before the trial; (2) The operation indication of knee joint replacement was clear, and the unilateral TKA was done with the first time; (3) The previous coagulation function was normal and there was no hematological disease; (4) All patients with no previous vascular embolic disease; (5) All patients with no history of anticoagulant use; (6) All patients with normal result in other laboratory tests; (7) No other procoagulant or anticoagulant drugs were used one week before surgery.

Exclusion criteria

Exclusion criteria: (1) The patients with other severe organic diseases; (2) The patients with blood transfusion history, severe bleeding tendency, local or systemic infection that could not be controlled in the near future; (3) The patients with invasive operation of knee joint in the past three months; (4) The patients with other contraindications who were not suitable for operation; (5) The patients with mental illness; (6) The patients who were allergic to the test drug; (7) Preoperative parasis of both lower extremities found to have signs of DVT.

Design outcomes

Primary

MeasureTime frame
Coagulation function indicators;Thromboelastography indicators;

Secondary

MeasureTime frame
Hemorheological indicators;Lower limb blood flow velocity;DVT incidence rate;Adverse reactions;

Countries

China

Contacts

Public ContactYang Yong

The Affiliated Hospital of Panzhihua University

yangyongyydr@21cn.com+86 812 334 7772

Outcome results

None listed

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