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

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: Rivaroxaban 10 MG; Drug: Rivaroxaban 20 MG; Drug: Low-molecular-weight heparin

• Registration Number: NCT03282643
• Lead Sponsor: Capital Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-16
• Study First Submitted: 2017-09-12
• Study First Submitted QC: 2017-09-13
• Study First Posted: 2017-09-14
• Primary Completion: 2018-06-30
• Status Verified: 2019-04
• Study Completion: 2019-04-01
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rivaroxaban 10mg daily	Rivaroxaban 10 MG	orally, 10 mg once daily for day1 and day 2 after femoral venepuncture
Rivaroxaban 20mg daily	Rivaroxaban 20 MG	orally, 10 mg twice daily for day1 and day 2 after femoral venepuncture
Low-molecular-weight heparin	Low-molecular-weight heparin	subcutaneously, 0.4 ml once daily, before femoral venepuncture (day1) and after the day of femoral venepuncture (day 2)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital; 🇨🇳 Beijing, China