Clinical study of individualized enoxaparin regimens to prevent deep vein thrombosis after joint replacement surgery

Individualized anticoagulation regimens with enoxaparin sodium for preventing deep vein thrombosis in TAT-identified high-risk DVT patients after joint replacement: a multicenter, randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600121160

Enrollment

Unknown

Registered

2026-03-26

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Deep vein thrombosis after joint replacement surgery

Interventions

Experimental Group:Individualized anticoagulation with enoxaparin sodium

Control Group:Fixed-dose anticoagulation with enoxaparin sodium

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18–80 years, with no gender restriction. 2. Body weight 40–100 kg (based on the enoxaparin sodium package insert). 3. Meet the indications for primary unilateral total hip or knee arthroplasty and are scheduled to undergo the procedure. 4. At high risk of postoperative DVT: TAT > 24.3 ng/mL on the first postoperative day. 5. Agree to participate in this study and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe cardiopulmonary disease, severe tumor, active infection, or active tuberculosis. 2. Contraindications to anticoagulation, or abnormal liver and kidney function (Child-Pugh class B or C). 3. Hypersensitivity to enoxaparin sodium. 4. Requirement for long-term therapeutic anticoagulation (e.g., atrial fibrillation, after mechanical valve replacement). 5. Preoperatively diagnosed bleeding disorders (e.g., hemophilia, hereditary hemorrhagic telangiectasia). 6. History of heparin-induced thrombocytopenia. 7. Abnormal coagulation function (e.g., platelet count < 100×10?/L, prothrombin time (PT) < 11 seconds, international normalized ratio (INR) < 0.8). 8. Preoperatively diagnosed lower extremity vascular disease or venous thrombosis.

Design outcomes

Primary

Measure	Time frame
Incidence of deep vein thrombosis (DVT) at 7 days postoperatively;	—

Secondary

Measure	Time frame
Postoperative length of hospital stay;Postoperative blood loss;Postoperative joint function score;DVT-related symptoms;Drug-related adverse events;Dynamic changes in medication-related laboratory test parameters within 7 days postoperatively;	—

Countries

China

Contacts

Public ContactXu Jie

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

lplllpfe@163.com+86 20 81332032

Outcome results

None listed

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