Prophylactic Anticoagulation for Catheter-related Thrombosis

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: Female

Summary

The main objective of this study is to compare the efficacy and safety of aspirin, low molecule heparin and rivaroxaban for preventing catheter-related thrombosis in middle-to-high-risk ambulatory patients with cancer and implantable venous access ports.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Treatments: Aspirin; Calcium heparin; Heparin; Rivaroxaban

Criteria

Inclusion Criteria:

1. age 18-75 years;

2. patients with malignant tumors who received implantable drug delivery devices as intravenous access for systematic chemotherapy;

3. Eastern Cooperative Oncology Group (ECOG) class 0-1;

4. expected to receive chemotherapy within 1 week of enrollment;

5. expected survival of more than 6 months;

6. ambulatory patients or outpatient chemotherapy patients whose intravenous chemotherapy less than 24 hours per hospital stay;

7. Khorana score 1-3 point.

Exclusion Criteria:

1. patients with a history of allergies to low molecular weight heparin, rivaroxaban, aspirin or other non-steroidal anti-inflammatory drugs, especially those with asthma, neurovascular edema or shock;

2. patients with bleeding risks: thrombocytopenia (platelet count < 50*109/L), clinically significant active bleeding, active gastric ulcer disease, severe arterial hypertension, history of previous stroke;

3. moderate to severe liver and kidney dysfunction;

4. pregnant or lactating women;

5. patients who are administered systemically with pyrrole-antimycotic agents (eg ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (eg ritonavir);

6. patients taking methotrexate;

7. patients with systemic use of non-steroidal anti-inflammatory drugs;

8. patients who have had anticoagulant drugs for any other reason.