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Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines (TRIM-Line)

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ClinicalTrials.gov Identifier: NCT03506815
Recruitment Status : Recruiting
First Posted : April 24, 2018
Last Update Posted : August 13, 2019
Sponsor:
Collaborators:
Queen Elizabeth II Health Sciences Centre
University of Alberta
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Upper Extremity Deep Vein Thrombosis Central Venous Catheter Thrombosis Cancer Drug: Rivaroxaban 10 MG Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Pilot Trial comparing two groups - Rivaroxaban 10mg po daily x90 days vs standard of care(usual treatment)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Investigating Primary Thromboprophylaxis With Rivaroxaban in Patients With Malignancy and Central Venous Catheters
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots
Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Experimental: 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.
Drug: Rivaroxaban 10 MG
Rivaroxaban 10mg po daily x 90 (+/- 3 days)
Other Name: Xarelto 10mg tablet po daily

No Intervention: Standard of care
No rivaroxaban prophylaxis. Management will be at the discretion of the attending physician.



Primary Outcome Measures :
  1. Pilot Feasibility Outcome- Enrolment [ Time Frame: 6 months ]
    Number of Participants recruited per centre per month


Secondary Outcome Measures :
  1. Consent rate [ Time Frame: 6 months ]
    Proportion of approached patients who consent to enter study.

  2. Loss to follow up [ Time Frame: 6 months ]
    During the 90 (+/-3) days of the trial

  3. Adherence to Therapy [ Time Frame: 6 months ]
    Good adherence defined as 80% or greater study medication taken

  4. Proportion of screened patients which meet eligibility criteria [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  1. CVC in place for >72 hours
  2. Patient requires anticoagulation for other indication
  3. Concomitant use of dual antiplatelet therapy
  4. Prior VTE
  5. Major bleeding event in the last 6 weeks
  6. Patient on concomitant medication with known interaction with rivaroxaban (eg. CYP3A4 inhibitor)
  7. Pregnancy (documentation of use of effective contraception if sexually active or negative B-Hcg required)
  8. Known renal failure, based on Creatinine clearance <30 mL/min (Cockcroft-Gault) (in the previous 3 months)
  9. Documented severe liver disease (eg. acute clinical hepatitis, chronic active hepatitis, cirrhosis or ALT >3ULN) ( in the previous 3 months)
  10. Known thrombocytopenia < 50x 109/L (in the previous 3 months)
  11. Allergy to rivaroxaban
  12. Life expectancy <6 months
  13. History of condition at increased bleeding risk including, but not limited to:

    1. Major surgical procedure or trauma within 30 days before the randomization visit
    2. Clinically significant gastrointestinal bleeding within 6 months before the randomization visit
    3. History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding
    4. Chronic hemorrhagic disorder
    5. Known intracranial neoplasm, arteriovenous malformation, or aneurysm
    6. Sustained uncontrolled hypertension: systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg
  14. Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin or acute leukemia or myelodysplastic syndrome
  15. Geographic inaccessibility
  16. Refused or unable to obtain consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506815


Contacts
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Contact: Rick T Ikesaka, MD 6139838867 rikesaka@mcmaster.ca
Contact: Marc Carrier, MD, MSc 6137378899 ext 73668 mcarrier@toh.ca

Locations
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Canada, Ontario
The Ottawa Hospital General Campus Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Queen Elizabeth II Health Sciences Centre
University of Alberta
Hamilton Health Sciences Corporation
Investigators
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Principal Investigator: Rick T Ikesaka, MD Ottawa Hospital Research Institute / Division of Hematology- The Ottawa Hospital

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03506815     History of Changes
Other Study ID Numbers: 001
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pilot Feasibility Study- no current plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Hospital Research Institute:
Upper Extremity Deep Vein Thrombosis
Thromboprophylaxis
Cancer
Randomized Trial
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Upper Extremity Deep Vein Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants