Clinical trial · Interventional
Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters
Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters: a Randomized Controlled Trial
NCT05029063CI-TRIAL-00091901TRIM-LinerecruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rivaroxaban 10 MG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Rivaroxaban 10mg OD
- interventionNames
- Drug: Rivaroxaban 10 MG
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- Identical Placebo 10mg OD
- interventionNames
- Drug: Rivaroxaban 10 MG
Primary outcomes (2)
- measure
- Major VTE prevention
- timeFrame
- 90 days (± 3 days) of randomization
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 consentReferences
Publications (1)
- BACKGROUNDIkesaka 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