Clinical trial · Interventional
Rivaroxaban Versus Low-molecular-weight Heparin for Preventing Thrombosis in Cancer Patients
Rivaroxaban Versus Low-molecular-weight Heparin in Preventing Thrombosis Among Cancer Patients After Femoral Venepuncture
NCT03282643CI-TRIAL-00038151completedPhase 1 / Phase 2ClinicalTrials.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 study is designed to compare the efficacy and safety of oral rivaroxaban and subcutaneous low-molecular-weight heparin in preventing femoral venepuncture associated thrombosis among cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low-molecular-weight heparin | Drug | — | UNRESOLVED |
| Rivaroxaban 10 MG | Drug | — | UNRESOLVED |
| Rivaroxaban 20 MG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Rivaroxaban 10mg daily
- description
- orally, 10 mg once daily for day1 and day 2 after femoral venepuncture
- interventionNames
- Drug: Rivaroxaban 10 MG
- type
- EXPERIMENTAL
- label
- Rivaroxaban 20mg daily
- description
- orally, 10 mg twice daily for day1 and day 2 after femoral venepuncture
- interventionNames
- Drug: Rivaroxaban 20 MG
- type
- ACTIVE_COMPARATOR
- label
- Low-molecular-weight heparin
- description
- subcutaneously, 0.4 ml once daily, before femoral venepuncture (day1) and after the day of femoral venepuncture (day 2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 to 85 * Histologically or cytologically confirmed advanced or metastatic solid tumors * Patients will be received femoral venepuncture for apheresis by cell separator, which is the necessary process to perform following adoptive cell immunotherapy. * Estimated life expectancy \> 3 months * Adequate hematologic function, with WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL (it is acceptable to have had prior transfusion), platelets ≥ 75,000/microliter; PT-INR \<1.5 (unless patient is receiving warfarin in which case PT-INR must be \<3), PTT \<1.5X ULN * Adequate renal and hepatic function, with serum creatinine \< 1.5 mg/dL, bilirubin \< 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), ALT and AST ≤ 2.5 x upper limit of normal. Exclusion Criteria: * known conditions associated with high risk of bleeding, known history of hemorrhagic diathesis * Platelet count \< 50 000 G/L * Active bleeding * Patients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Autoimmune related thyroid disease and vitiligo are permitted. * Patients with obstructive jaundice * Patients with Spleen hyperfunction * Presence of an active acute or chronic infection including: a urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot). Patients with HIV are excluded based on immuno-suppression, which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections. * Pregnant or breast-feeding women,or lack of effective contraceptive treatment for women of childbearing age.;
References
Publications (1)
- DERIVEDWang X, Wang S, Morse MA, Jiang N, Zhao Y, Song Y, Zhou L, Huang H, Zhou X, Hobeika A, Ren J, Lyerly HK. Prospective randomized comparative study on rivaroxaban and LMWH for prophylaxis of post-apheresis thrombosis in adoptive T cell immunotherapy cancer patients. J Thromb Thrombolysis. 2019 May;47(4):505-511. doi: 10.1007/s11239-019-01844-7. PMID 30903459