A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Investigating Primary Thromboprophylaxis With Rivaroxaban in Patients With Malignancy and Central Venous Catheters
Overview
- Phase
- Phase 3
- Intervention
- Rivaroxaban 10 MG
- Conditions
- Upper Extremity Deep Vein Thrombosis
- Sponsor
- Ottawa Hospital Research Institute
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Primary Feasibility Outcome - Number of Participants Recruited Per Month
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Purpose of the Pilot Trial:
To determine the feasibility of conducting a multicentre randomized open label controlled trial evaluating the use of prophylactic dose rivaroxaban to prevent central venous catheter (CVC) associated venous thromboembolism (VTE) among cancer patients.
Hypothesis: treatment with low dose rivaroxaban (10mg) will reduce the incidence of upper extremity venous thrombosis in a high risk population with cancer and CVC.
Detailed Description
Design: This is a pilot interventional study to be conducted at 2 Canadian Centres. The Ottawa Hospital and Juravinski Hospital. It is an open label randomized controlled trial. Consenting participants, meeting eligibility criteria will be randomized at the time of enrollment to one of two groups. Rivaroxaban 10mg by mouth daily x 90 (+/- 3) days OR Standard of Care Participants in the treatment arm will have study drug dispensed at Day 1 and take medication for 90 days or until CVC is removed. Follow up visits (in person or phone) will occur at Day 30 (+/- 3 days) and Day 90 (+/- 3 days). Overall, participants will be followed for 3 months. Adverse events will be collected for the first 90 days. Outcomes The primary feasibility outcome for the pilot study is the number of participants recruited per centre per month. We will obtain baseline details of the patient's type, location and treatment of cancer, comorbidities and medications. Secondary feasibility outcomes of the pilot study will include, consent rates, loss to follow up, adherence to therapy defining 80% or greater medication taken as having good adherence to study drug, proportion of screened patients who meet eligibility criteria.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1.Patients 18 years of age or older with a new or existing diagnosis of cancer with a CVC inserted within the last 72 hours.
Exclusion Criteria
- •CVC in place for \>72 hours
- •Patient requires anticoagulation for other indication
- •Concomitant use of dual antiplatelet therapy
- •Major bleeding event in the last 6 weeks
- •Patient on concomitant medication with known interaction with rivaroxaban (eg. CYP3A4 inhibitor)
- •Pregnancy (documentation of use of effective contraception if sexually active or negative B-Hcg required)
- •Known renal failure, based on Creatinine clearance \<30 mL/min (Cockcroft-Gault) (in the previous 3 months)
- •Documented severe liver disease (eg. acute clinical hepatitis, chronic active hepatitis, cirrhosis or ALT \>3ULN) ( in the previous 3 months)
- •Known thrombocytopenia \< 50x 109/L (in the previous 3 months)
- •Allergy to rivaroxaban
Arms & Interventions
Rivaroxaban Thromboprophylaxis
Rivaroxaban 10 mg po daily for 90 days(+/- 3 days). After the Day - 90 follow up, the study treatment will be discontinued and subsequent treatment will be at the discretion of the attending physician.
Intervention: Rivaroxaban 10 MG
Outcomes
Primary Outcomes
Primary Feasibility Outcome - Number of Participants Recruited Per Month
Time Frame: 12 months
A convenience sample size of 100 patients was chosen to allow reporting of the average monthly recruitment.
Secondary Outcomes
- Secondary Feasibility Outcomes - Percentage of Participants With Good Adherence to Therapy(90 days)