Status:
COMPLETED
Rivaroxaban Versus Low-molecular-weight Heparin for Preventing Thrombosis in Cancer Patients
Lead Sponsor:
Capital Medical University
Conditions:
Neoplasms
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
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 patient...
Eligibility Criteria
Inclusion
- 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
- 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.;
Key Trial Info
Start Date :
February 16 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2019
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT03282643
Start Date
February 16 2016
End Date
April 1 2019
Last Update
April 16 2019
Active Locations (1)
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1
Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital
Beijing, China, 100038