CompletedPhase 3

Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines

Canada105 participantsStarted 2019-03-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓.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)

What they're measuring

Primary Feasibility Outcome - Number of Participants Recruited Per Month

Timeframe: 12 months

Trial details

NCT IDNCT03506815

SponsorOttawa Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-14

Results submitted2023-01-13

View on ClinicalTrials.gov More Upper Extremity Deep Vein Thrombosis trials