Clinical trial · Interventional
Prophylactic Anticoagulation for Catheter-related Thrombosis
The Efficacy and Safety of Prophylactic Anticoagulation for Catheter-related Thrombosis in Patients With Cancer and Implantable Venous Access Ports: a Prospective Multi-center Randomized Controlled Trial.
NCT04256525CI-TRIAL-00045718unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patients With Tumor | Neoplasm | ALIAS | 0.85 |
| Prophylactic Anticoagulation | — | UNRESOLVED | — |
| Venous Thrombosis Due to Central Venous Access Device (Disorder) | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aspirin 100mg | Drug | Aspirin | ALIAS |
| low molecule heparin | Drug | — | UNRESOLVED |
| Rivaroxaban 10mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Aspirin 100mg
- interventionNames
- Drug: Aspirin 100mg
- type
- EXPERIMENTAL
- label
- rivaroxaban 10mg
- interventionNames
- Drug: Rivaroxaban 10mg
- type
- EXPERIMENTAL
- label
- low molecule heparin
- interventionNames
- Drug: low molecule heparin
- type
- NO_INTERVENTION
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.