Prophylactic Anticoagulation for Catheter-related Thrombosis (NCT04256525) | Clinical Trial Compass
UnknownPhase 4
Prophylactic Anticoagulation for Catheter-related Thrombosis
China1,640 participantsStarted 2020-05-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. age 18-75 years;
✓. patients with malignant tumors who received implantable drug delivery devices as intravenous access for systematic chemotherapy;
✓. Eastern Cooperative Oncology Group (ECOG) class 0-1;
✓. expected to receive chemotherapy within 1 week of enrollment;
✓. expected survival of more than 6 months;
✓. ambulatory patients or outpatient chemotherapy patients whose intravenous chemotherapy less than 24 hours per hospital stay;
✓. Khorana score 1-3 point.
Exclusion criteria
✕. 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;
✕. 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;
✕. moderate to severe liver and kidney dysfunction;
✕. pregnant or lactating women;
✕. patients who are administered systemically with pyrrole-antimycotic agents (eg ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (eg ritonavir);
What they're measuring
1
occurrence of catheter-related thrombosis
Timeframe: from enrollment to the first time of occurrence of catheter-related thrombosis, up to 1 month after the completion of last chemotherapy cycle
2
occurrence of major-bleeding event
Timeframe: from enrollment to the first time of occurrence of major-bleeding event, up to 1 month after the completion of last chemotherapy cycle
Trial details
NCT IDNCT04256525
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University