Rivaroxaban Versus Low-molecular-weight Heparin for Preventing Thrombosis in Cancer Patients

NCT ID: NCT03282643

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-16
• Study Completion Date: 2019-04-01

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.

Conditions

Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Rivaroxaban 10mg daily

orally, 10 mg once daily for day1 and day 2 after femoral venepuncture

Group Type: EXPERIMENTAL

Rivaroxaban 10 MG

Intervention Type: DRUG

Rivaroxaban pill 10mg qd, day1 and day2 after femoral venepuncture

Rivaroxaban 20mg daily

orally, 10 mg twice daily for day1 and day 2 after femoral venepuncture

Group Type: EXPERIMENTAL

Rivaroxaban 20 MG

Intervention Type: DRUG

Rivaroxaban pill 10mg bid, day1 and day2 after femoral venepuncture

Low-molecular-weight heparin

subcutaneously, 0.4 ml once daily, before femoral venepuncture (day1) and after the day of femoral venepuncture (day 2)

Group Type: ACTIVE_COMPARATOR

Low-molecular-weight heparin

Intervention Type: DRUG

0.4 ml once daily, before femoral venepuncture(day1) and the following day (day 2)

Interventions

Rivaroxaban 10 MG

Rivaroxaban pill 10mg qd, day1 and day2 after femoral venepuncture

Intervention Type: DRUG

Rivaroxaban 20 MG

Rivaroxaban pill 10mg bid, day1 and day2 after femoral venepuncture

Intervention Type: DRUG

Low-molecular-weight heparin

0.4 ml once daily, before femoral venepuncture(day1) and the following day (day 2)

Intervention Type: DRUG

Eligibility Criteria

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.;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jun Ren MD, PhD

Dean & Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital

Beijing, , China

Countries

China

References

Wang 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.

Reference Type: DERIVED

PMID: 30903459 (View on PubMed)

Other Identifiers

Rivaroxaban vs heparin

Identifier Type: -

Identifier Source: org_study_id