Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines

Study Overview
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Brief Summary
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Purpose of 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. Design: This is a pilot interventional study to be conducted at 3 Canadian Centres. The Ottawa Hospital, QEII Health Science Centre and University of Alberta 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 po 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. Follow up visits (in person or phone) will occur at Day 30 (+/- 3 days) and Day 90 (+/- 3 days) month and 3 months post enrollment. 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.

Official Title
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A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Investigating Primary Thromboprophylaxis With Rivaroxaban in Patients With Malignancy and Central Venous Catheters

Conditions
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Upper Extremity Deep Vein Thrombosis, Central Venous Catheter Thrombosis, Cancer

Intervention / Treatment
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* Drug: Rivaroxaban 10 MG


Participation Criteria
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Eligibility Criteria
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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 Prior VTE 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 Life expectancy <6 months History of condition at increased bleeding risk including, but not limited to: Major surgical procedure or trauma within 30 days before the randomization visit Clinically significant gastrointestinal bleeding within 6 months before the randomization visit History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding Chronic hemorrhagic disorder Known intracranial neoplasm, arteriovenous malformation, or aneurysm Sustained uncontrolled hypertension: systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin or acute leukemia or myelodysplastic syndrome Geographic inaccessibility Refused or unable to obtain consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Pilot Trial comparing two groups - Rivaroxaban 10mg po daily x90 days vs standard of care(usual treatment)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rivaroxaban Thromboprophylaxis<br>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. | Drug: Rivaroxaban 10 MG<br>* Rivaroxaban 10mg po daily x 90 (+/- 3 days)<br>* Other names: Xarelto 10mg tablet po daily;|
| No Intervention: Standard of care<br>No rivaroxaban prophylaxis. Management will be at the discretion of the attending physician. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pilot Feasibility Outcome- Enrolment | Number of Participants recruited per centre per month | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consent rate | Proportion of approached patients who consent to enter study. | 6 months | 
| Loss to follow up | During the 90 (+/-3) days of the trial | 6 months | 
| Adherence to Therapy | Good adherence defined as 80% or greater study medication taken | 6 months | 
| Proportion of screened patients which meet eligibility criteria |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Upper Extremity Deep Vein Thrombosis, Thromboprophylaxis, Cancer, Randomized Trial