Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters

Phase 3RecruitingNCT05029063

Ottawa Hospital Research Institute1,828 enrolled

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

1,828

Conditions

Venous Thromboembolism Cancer

Interventions

Rivaroxaban 10 MGDRUG

Identical comparator drug

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Nova Scotia Health

Halifax, Nova Scotia, Canada

RECRUITING

William Osler Health System

Brampton, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

Major VTE prevention

Number of Major VTE's in patient population

Time frame: 90 days (± 3 days) of randomization

Episodes of Major Bleeding

Number of participants who had a major bleed

Time frame: 90 days (± 3 days) of randomization

Secondary Outcomes

Number of participants with Clinically Relevant Non-Major Bleeding (CRNMB)

As defined by ISTH

Time frame: 90 days (± 3 days) of randomization

Number of patients who had a fatal VTE

Fatal VTE

Time frame: 90 days (± 3 days) of randomization

Number of patients who benefitted from using the experimental intervention

Composite of major VTE and major bleeding

Time frame: 90 days (± 3 days) of randomization

Incidental and Symptomatic

Time frame: 90 days (± 3 days) of randomization

Proximal CVC VTE

Incidental and symptomatic proximal (axillary vein or more proximal) upper extremity CVC-related DVT

Time frame: 90 days (± 3 days) of randomization

Distal CVC VTE

Incidental and symptomatic distal (brachial vein) or proximal (axillary vein or more proximal) upper extremity CVC-related DVT

Time frame: 90 days (± 3 days) of randomization

Central Contacts

Bashour Yazji

CONTACT

613-737-8899 byazji@ohri.ca

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

HHS - Juravinski Hospital

Hamilton, Ontario, Canada

RECRUITING

Ottawa Hospital Research Institute- The Ottawa Hospital

Ottawa, Ontario, Canada

RECRUITING

Sault Area Hospital

Sault Ste. Marie, Ontario, Canada

RECRUITING

Niagara Health

St. Catharines, Ontario, Canada

RECRUITING

Windsor Regional Hospital

Windsor, Ontario, Canada

RECRUITING

CISSS Montérégie-Centre HOPITAL CHARLES LEMOYNE

Greenfield Park, Quebec, Canada

RECRUITING

Centre Intégré de santé et de services sociaux de Chaudière-Appalaches

Lévis, Quebec, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, Canada

RECRUITING

...and 1 more locations

Proximal Lower extremity DVT

Incidental and symptomatic proximal (popliteal vein or more proximal) lower extremity DVT

Time frame: 90 days (± 3 days) of randomization

Distal Lower extremity DVT

Incidental and symptomatic distal or proximal (popliteal vein or more proximal) 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

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

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

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

Time frame: 90 days (± 3 days) of randomization

CVC Life-span

Life span of inserted CVC

Time frame: 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.

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

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

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

Number of participants who passed away during the trial

Overall mortality

Time frame: 90 days (± 3 days) of randomization

EQ-5D-5L Health-related quality of life

Health-related quality of life

Time frame: 90 days (± 3 days) of randomization

ICER

Incremental cost-effectiveness ratio (ICER) at one year

Time frame: 1 Year