Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters

Cancer Clinical Trial

— TRIM-Line  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05029063
• Other study ID #: TRIM-Line 3698
• Status: Recruiting
• Phase: Phase 3
• Start date: October 5, 2022
• Est. completion date: December 2027

Study information

• Verified date: September 2023
• Source: Ottawa Hospital Research Institute
• Contact: Amanda Pecarskie
• Phone: 613-737-8899
• Email: apecarskie[@]ohri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1828
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Rivaroxaban 10 MG
Identical comparator drug

Locations

Country	Name	City	State
Canada	CISSS Montérégie-Centre HOPITAL CHARLES LEMOYNE	Greenfield Park	Quebec
Canada	HHS - Juravinski Hospital	Hamilton	Ontario
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Ottawa Hospital Research Institute- The Ottawa Hospital	Ottawa	Ontario
Canada	Sault Area Hospital	Sault Ste Marie	Ontario
Canada	Niagara Health	St. Catharines	Ontario
Canada	Windsor Regional Hospital	Windsor	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major VTE prevention	Number of Major VTE's in patient population	90 days (± 3 days) of randomization
Primary	Episodes of Major Bleeding	Number of participants who had a major bleed	90 days (± 3 days) of randomization
Secondary	Number of participants with Clinically Relevant Non-Major Bleeding (CRNMB)	As defined by ISTH	90 days (± 3 days) of randomization
Secondary	Number of patients who had a fatal VTE	Fatal VTE	90 days (± 3 days) of randomization
Secondary	Number of patients who benefitted from using the experimental intervention	Composite of major VTE and major bleeding	90 days (± 3 days) of randomization
Secondary	PE	Incidental and Symptomatic	90 days (± 3 days) of randomization
Secondary	Proximal CVC VTE	Incidental and symptomatic proximal (axillary vein or more proximal) upper extremity CVC-related DVT	90 days (± 3 days) of randomization
Secondary	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
Secondary	Proximal Lower extremity DVT	Incidental and symptomatic proximal (popliteal vein or more proximal) lower extremity DVT	90 days (± 3 days) of randomization
Secondary	Distal Lower extremity DVT	Incidental and symptomatic distal or proximal (popliteal vein or more proximal) lower extremity DVT	90 days (± 3 days) of randomization
Secondary	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
Secondary	Number of participants with Superficial upper or lower extremity vein thrombosis	Superficial upper or lower extremity vein thrombosis	90 days (± 3 days) of randomization
Secondary	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
Secondary	CVC Life-span	Life span of inserted CVC	90 days (± 3 days) of randomization
Secondary	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
Secondary	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
Secondary	Number of participants who passed away during the trial	Overall mortality	90 days (± 3 days) of randomization
Secondary	EQ-5D-5L Health-related quality of life	Health-related quality of life	90 days (± 3 days) of randomization
Secondary	ICER	Incremental cost-effectiveness ratio (ICER) at one year	1 Year