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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 : Completed
First Posted : April 24, 2018
Last Update Posted : July 23, 2020
Sponsor:
Collaborators:
Queen Elizabeth II Health Sciences Centre
University of Alberta
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Tracking Information
First Submitted Date  ICMJE March 19, 2018
First Posted Date  ICMJE April 24, 2018
Last Update Posted Date July 23, 2020
Actual Study Start Date  ICMJE March 15, 2019
Actual Primary Completion Date May 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
Pilot Feasibility Outcome- Enrolment [ Time Frame: 6 months ]
Number of Participants recruited per centre per month
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
  • Consent rate [ Time Frame: 6 months ]
    Proportion of approached patients who consent to enter study.
  • Loss to follow up [ Time Frame: 6 months ]
    During the 90 (+/-3) days of the trial
  • Adherence to Therapy [ Time Frame: 6 months ]
    Good adherence defined as 80% or greater study medication taken
  • Proportion of screened patients which meet eligibility criteria [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines
Official Title  ICMJE A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Investigating Primary Thromboprophylaxis With Rivaroxaban in Patients With Malignancy and Central Venous Catheters
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Upper Extremity Deep Vein Thrombosis
  • Central Venous Catheter Thrombosis
  • Cancer
Intervention  ICMJE Drug: Rivaroxaban 10 MG
Rivaroxaban 10mg po daily x 90 (+/- 3 days)
Other Name: Xarelto 10mg tablet po daily
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Rivaroxaban 10 MG
  • No Intervention: Standard of care
    No rivaroxaban prophylaxis. Management will be at the discretion of the attending physician.
Publications * Ikesaka R, Siegal D, Mallick R, Wang TF, Witham D, Webb C, Carrier M; Canadian Venous Thromboembolism Research Network (CanVECTOR). Thromboprophylaxis with rivaroxaban in patients with malignancy and central venous lines (TRIM-Line): A two-center open-label pilot randomized controlled trial. Res Pract Thromb Haemost. 2021 May 5;5(4):e12517. doi: 10.1002/rth2.12517. eCollection 2021 May.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2020)
100
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2018)
50
Actual Study Completion Date  ICMJE June 14, 2020
Actual Primary Completion Date May 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03506815
Other Study ID Numbers  ICMJE 001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Pilot Feasibility Study- no current plan to share IPD
Responsible Party Ottawa Hospital Research Institute
Study Sponsor  ICMJE Ottawa Hospital Research Institute
Collaborators  ICMJE
  • Queen Elizabeth II Health Sciences Centre
  • University of Alberta
  • Hamilton Health Sciences Corporation
Investigators  ICMJE
Principal Investigator: Rick T Ikesaka, MD Ottawa Hospital Research Institute / Division of Hematology- The Ottawa Hospital
PRS Account Ottawa Hospital Research Institute
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP