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

Neoplasms Clinical Trial

Official title:

Rivaroxaban Versus Low-molecular-weight Heparin in Preventing Thrombosis Among Cancer Patients After Femoral Venepuncture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03282643
• Other study ID #: Rivaroxaban vs heparin
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 16, 2016
• Est. completion date: April 1, 2019

Study information

• Verified date: April 2019
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: April 1, 2019
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.;

Related Conditions & MeSH terms

• Neoplasms
• Thrombosis

Intervention

Drug:
• Rivaroxaban 10 MG
Rivaroxaban pill 10mg qd, day1 and day2 after femoral venepuncture
• Rivaroxaban 20 MG
Rivaroxaban pill 10mg bid, day1 and day2 after femoral venepuncture
• Low-molecular-weight heparin
0.4 ml once daily, before femoral venepuncture(day1) and the following day (day 2)

Locations

Country	Name	City	State
China	Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of deep venous thrombosis	the incidence of deep venous thrombosis of the legs by the systematic examinations performed at the end of the 4-week after femoral venepuncture	4 weeks
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Number of participants with treatment-related adverse events as assessed by CTCAE v 3.0	4 weeks