Neoplasms
Conditions
Brief summary
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.
Interventions
Rivaroxaban pill 10mg qd, day1 and day2 after femoral venepuncture
Rivaroxaban pill 10mg bid, day1 and day2 after femoral venepuncture
0.4 ml once daily, before femoral venepuncture(day1) and the following day (day 2)
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of deep venous thrombosis | 4 weeks | the incidence of deep venous thrombosis of the legs by the systematic examinations performed at the end of the 4-week after femoral venepuncture |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 4 weeks | Number of participants with treatment-related adverse events as assessed by CTCAE v 3.0 |
Countries
China
Outcome results
None listed