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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Rivaroxaban 10mg OD |
|
| Control | Placebo Comparator | Identical Placebo 10mg OD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban 10 MG | Drug | Identical comparator drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major VTE prevention | Number of Major VTE's in patient population | 90 days (± 3 days) of randomization |
| Episodes of Major Bleeding | Number of participants who had a major bleed | 90 days (± 3 days) of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Clinically Relevant Non-Major Bleeding (CRNMB) | As defined by ISTH | 90 days (± 3 days) of randomization |
| Number of patients who had a fatal VTE | Fatal VTE |
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Inclusion Criteria:
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:
Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin only
Refused or unable to obtain consent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bashour Yazji | Contact | 613-737-8899 | 73958 | byazji@ohri.ca |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Marc Carrier | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nova Scotia Health | Recruiting | Halifax | Nova Scotia | Canada | ||
| William Osler Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34027291 | Background | 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. |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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Double Blind Randomized Control Trial
| 90 days (± 3 days) of randomization |
| Number of patients who benefitted from using the experimental intervention | Composite of major VTE and major bleeding | 90 days (± 3 days) of randomization |
| PE | Incidental and Symptomatic | 90 days (± 3 days) of randomization |
| Proximal CVC VTE | Incidental and symptomatic proximal (axillary vein or more proximal) upper extremity CVC-related DVT | 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 | 90 days (± 3 days) of randomization |
| Proximal Lower extremity DVT | Incidental and symptomatic proximal (popliteal vein or more proximal) lower extremity DVT | 90 days (± 3 days) of randomization |
| Distal Lower extremity DVT | 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 | 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 | Superficial upper or lower extremity vein thrombosis | 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 | 90 days (± 3 days) of randomization |
| CVC Life-span | 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. | 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 | 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 | Overall mortality | 90 days (± 3 days) of randomization |
| EQ-5D-5L Health-related quality of life | Health-related quality of life | 90 days (± 3 days) of randomization |
| ICER | Incremental cost-effectiveness ratio (ICER) at one year | 1 Year |
| Recruiting |
| Brampton |
| Ontario |
| L6R 3J7 |
| Canada |
| HHS - Juravinski Hospital | Recruiting | Hamilton | Ontario | L8V 1C3 | Canada |
| Ottawa Hospital Research Institute- The Ottawa Hospital | Recruiting | Ottawa | Ontario | K1H8L6 | Canada |
|
| Sault Area Hospital | Recruiting | Sault Ste. Marie | Ontario | 750 Great Northern Rd. | Canada |
| Niagara Health | Recruiting | St. Catharines | Ontario | L2S0A9 | Canada |
| Windsor Regional Hospital | Recruiting | Windsor | Ontario | N8W 1L9 | Canada |
| CISSS Montérégie-Centre HOPITAL CHARLES LEMOYNE | Recruiting | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Centre Intégré de santé et de services sociaux de Chaudière-Appalaches | Recruiting | Lévis | Quebec | Canada |
| Jewish General Hospital | Recruiting | Montreal | Quebec | H3T 1E2 | Canada |
| McGill University Health Center | Recruiting | Montreal | Quebec | Canada |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |