Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters (TRIM-Line)

July 3, 2025 updated by: Ottawa Hospital Research Institute

Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters: a Randomized Controlled Trial

The purpose of the full trial is to determine the efficacy and safety of prophylactic dose rivaroxaban to prevent VTE among cancer patients with CVC.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

TRIM-Line is a double blind randomized controlled trial comparing rivaroxaban 10mg po daily vs placebo in patients with active cancer and indwelling CVC. This will involve 9 centers across Canada.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1828

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Bashour Yazji
  • Phone Number: 73958 613-737-8899
  • Email: byazji@ohri.ca

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Recruiting
        • Nova Scotia Health
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • Recruiting
        • William Osler Health System
      • Hamilton, Ontario, Canada, L8V 1C3
        • Recruiting
        • HHS - Juravinski Hospital
      • Ottawa, Ontario, Canada, K1H8L6
        • Recruiting
        • Ottawa Hospital Research Institute- The Ottawa Hospital
        • Contact:
        • Principal Investigator:
          • Marc Carrier, Dr
        • Sub-Investigator:
          • Tzu-Fei Wang, Dr
        • Contact:
      • Sault Ste Marie, Ontario, Canada, 750 Great Northern Rd.
        • Recruiting
        • Sault Area Hospital
      • St. Catharines, Ontario, Canada, L2S0A9
        • Recruiting
        • Niagara Health
      • Windsor, Ontario, Canada, N8W 1L9
        • Recruiting
        • Windsor Regional Hospital
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Recruiting
        • CISSS Montérégie-Centre HOPITAL CHARLES LEMOYNE
      • Lévis, Quebec, Canada
        • Recruiting
        • Centre integre de sante et de services sociaux de Chaudiere-Appalaches
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
      • Montreal, Quebec, Canada
        • Recruiting
        • McGill University Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients 18 years of age or older with a new or existing diagnosis of cancer and a CVC inserted in the last 72 hours.

Exclusion criteria:

  1. CVC in place for >72 hours
  2. Patient requires anticoagulation for other indications
  3. Concomitant use of dual antiplatelet therapy
  4. Major bleeding event in the last 4 weeks
  5. Patients receiving concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp (such as cobicistat, ketoconazole, itraconazole, posaconazole, or ritonavir).
  6. Known pregnancy or plan to become pregnant in next 3 months
  7. Severe renal insufficiency (Creatinine clearance <30 mL/min (defined by Cockcroft-Gault) in the previous 3 months
  8. Documented severe liver disease (e.g., acute clinical hepatitis, chronic active hepatitis or cirrhosis) in the previous 3 months
  9. Known thrombocytopenia (platelet count < 50x 109/L) in the previous 3 months
  10. Known allergy to rivaroxaban
  11. Life expectancy <3 months

  12. History of condition at increased bleeding risk including, but not limited to:

    1. cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, spontaneous or acquired impairment of hemostasis in the past 4 weeks.
    2. Chronic hemorrhagic disorder
  13. Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin only
  14. Refused or unable to obtain consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
Rivaroxaban 10mg OD
Drug: Rivaroxaban 10 MG
Identical comparator drug
Other Names:
  • Placebo
Placebo Comparator: Control
Identical Placebo 10mg OD
Drug: Rivaroxaban 10 MG
Identical comparator drug
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Major VTE prevention
Time Frame: 90 days (± 3 days) of randomization
Number of Major VTE's in patient population
90 days (± 3 days) of randomization
Episodes of Major Bleeding
Time Frame: 90 days (± 3 days) of randomization
Number of participants who had a major bleed
90 days (± 3 days) of randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with Clinically Relevant Non-Major Bleeding (CRNMB)
Time Frame: 90 days (± 3 days) of randomization
As defined by ISTH
90 days (± 3 days) of randomization
Number of patients who had a fatal VTE
Time Frame: 90 days (± 3 days) of randomization
Fatal VTE
90 days (± 3 days) of randomization
Number of patients who benefitted from using the experimental intervention
Time Frame: 90 days (± 3 days) of randomization
Composite of major VTE and major bleeding
90 days (± 3 days) of randomization
PE
Time Frame: 90 days (± 3 days) of randomization
Incidental and Symptomatic
90 days (± 3 days) of randomization
Proximal CVC VTE
Time Frame: 90 days (± 3 days) of randomization
Incidental and symptomatic proximal (axillary vein or more proximal) upper extremity CVC-related DVT
90 days (± 3 days) of randomization
Distal CVC VTE
Time Frame: 90 days (± 3 days) of randomization
Incidental and symptomatic distal (brachial vein) or proximal (axillary vein or more proximal) upper extremity CVC-related DVT
90 days (± 3 days) of randomization
Proximal Lower extremity DVT
Time Frame: 90 days (± 3 days) of randomization
Incidental and symptomatic proximal (popliteal vein or more proximal) lower extremity DVT
90 days (± 3 days) of randomization
Distal Lower extremity DVT
Time Frame: 90 days (± 3 days) of randomization
Incidental and symptomatic distal or proximal (popliteal vein or more proximal) lower extremity DVT
90 days (± 3 days) of randomization
Number of participants with Unusual site thrombosis including: splanchnic vein (portal, splenic, superior mesenteric, inferior mesenteric, hepatic) cerebral vein, renal or gonadal vein thromboses
Time Frame: 90 days (± 3 days) of randomization
Unusual site thrombosis including: splanchnic vein (portal, splenic, superior mesenteric, inferior mesenteric, hepatic) cerebral vein, renal or gonadal vein thromboses
90 days (± 3 days) of randomization
Number of participants with Superficial upper or lower extremity vein thrombosis
Time Frame: 90 days (± 3 days) of randomization
Superficial upper or lower extremity vein thrombosis
90 days (± 3 days) of randomization
CVC Life-span
Time Frame: 90 days (± 3 days) of randomization
Life span of inserted CVC
90 days (± 3 days) of randomization
Number of patients with CVC occlusion occurring after the start of therapy, defined as an obstruction of the CVC lumen that prevents or limits the ability to flush, withdraw blood and/or administer solutions or medications.
Time Frame: 90 days (± 3 days) of randomization
CVC occlusion occurring after the start of therapy, defined as an obstruction of the CVC lumen that prevents or limits the ability to flush, withdraw blood and/or administer solutions or medications.
90 days (± 3 days) of randomization
Number of patients with CVC-related blood stream infection defined as the presence of bacteremia originating from the CVC according to the definition from the Centers for Disease Control and Prevention
Time Frame: 90 days (± 3 days) of randomization
CVC-related blood stream infection defined as the presence of bacteremia originating from the CVC according to the definition from the Centers for Disease Control and Prevention
90 days (± 3 days) of randomization
Number of participants who passed away during the trial
Time Frame: 90 days (± 3 days) of randomization
Overall mortality
90 days (± 3 days) of randomization
EQ-5D-5L Health-related quality of life
Time Frame: 90 days (± 3 days) of randomization
Health-related quality of life
90 days (± 3 days) of randomization
ICER
Time Frame: 1 Year
Incremental cost-effectiveness ratio (ICER) at one year
1 Year
Number of participants with an arterial thromboembolic event including: MI, stroke, peripheral arterial disease
Time Frame: 90 days (± 3 days) of randomization
Arterial thromboembolic events defined as a diagnostically confirmed final clinical diagnosis of myocardial infarction, stroke or peripheral arterial disease involving the following arterial vascular beds: carotid, upper or lower extremity, gastrointestinal tract, liver, spleen, or kidney
90 days (± 3 days) of randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ottawa Hospital Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr. Marc Carrier, Ottawa Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRIM-Line 3698

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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