NCT03506815

Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Upper Extremity Deep Vein Thrombosis
• Central Venous Catheter Thrombosis
• Cancer

Interventions

Type	Name	Description
DRUG	Rivaroxaban 10 MG	Rivaroxaban 10mg po daily x 90 (+/- 3 days)

Timeline

• Start date: 2019-03-15
• Primary completion: 2020-05-14
• Completion: 2020-06-14
• First posted: 2018-04-24
• Last updated: 2024-07-05
• Results posted: 2024-07-05

Locations

1 site across 1 country: Canada