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OpenTrials
Completed

NCT Number: NCT03282643

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

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.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital

Beijing, 100038, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.;

Treatment and study plan

Rivaroxaban 10 MG

Drug

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

Rivaroxaban 20 MG

Drug

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

Low-molecular-weight heparin

Drug

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

Primary outcomes

  1. Incidence rate of deep venous thrombosis

    Time frame: 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 outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: 4 weeks

    Number of participants with treatment-related adverse events as assessed by CTCAE v 3.0

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Sep 14, 2017
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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