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Recruiting NCT05029063

Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters

Phase III Interventional Venous Thromboembolism Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rivaroxaban 10 MG.
Who it may be relevant to
Registry conditions: Venous Thromboembolism, Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Drug Rivaroxaban 10 MG
    Identical comparator drug

Primary outcome measures

  • Major VTE prevention [Time frame: 90 days (± 3 days) of randomization]
  • Episodes of Major Bleeding [Time frame: 90 days (± 3 days) of randomization]
Secondary outcome measures (12)
  • Number of participants with Clinically Relevant Non-Major Bleeding (CRNMB) [Time frame: 90 days (± 3 days) of randomization]
  • Number of patients who had a fatal VTE [Time frame: 90 days (± 3 days) of randomization]
  • Number of patients who benefitted from using the experimental intervention [Time frame: 90 days (± 3 days) of randomization]
  • PE [Time frame: 90 days (± 3 days) of randomization]
  • Proximal CVC VTE [Time frame: 90 days (± 3 days) of randomization]
  • Distal CVC VTE [Time frame: 90 days (± 3 days) of randomization]
  • Proximal Lower extremity DVT [Time frame: 90 days (± 3 days) of randomization]
  • Distal Lower extremity DVT [Time frame: 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]
  • Number of participants with Superficial upper or lower extremity vein thrombosis [Time frame: 90 days (± 3 days) of randomization]
  • Number of participants with an arterial thromboembolic event including: MI, stroke, peripheral arterial disease [Time frame: 90 days (± 3 days) of randomization]
  • CVC Life-span [Time frame: 90 days (± 3 days) of randomization]

Eligibility criteria

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

  • CVC in place for >72 hours
  • Patient requires anticoagulation for other indications
  • Concomitant use of dual antiplatelet therapy
  • Major bleeding event in the last 4 weeks
  • Patients receiving concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp (such as cobicistat, ketoconazole, itraconazole, posaconazole, or ritonavir).
  • Known pregnancy or plan to become pregnant in next 3 months
  • Severe renal insufficiency (Creatinine clearance <30 mL/min (defined by Cockcroft-Gault) in the previous 3 months
  • Documented severe liver disease (e.g., acute clinical hepatitis, chronic active hepatitis or cirrhosis) in the previous 3 months
  • Known thrombocytopenia (platelet count < 50x 109/L) in the previous 3 months
  • Known allergy to rivaroxaban
  • Life expectancy <3 months
  • History of condition at increased bleeding risk including, but not limited to:
  • cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, spontaneous or acquired impairment of hemostasis in the past 4 weeks.
  • Chronic hemorrhagic disorder
  • Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin only
  • Refused or unable to obtain consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Canada · 11 centers
  • Nova Scotia Health — Halifax
  • William Osler Health System — Brampton
  • HHS - Juravinski Hospital — Hamilton
  • Ottawa Hospital Research Institute- The Ottawa Hospital — Ottawa
  • Sault Area Hospital — Sault Ste. Marie
  • Niagara Health — St. Catharines
  • Windsor Regional Hospital — Windsor
  • CISSS Montérégie-Centre HOPITAL CHARLES LEMOYNE — Greenfield Park
  • … and 3 more centers

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. PMID 34027291

Identifiers

NCT: NCT05029063 · TRIM-Line 3698

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗