Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines

NCT ID: NCT03506815

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-15
• Study Completion Date: 2020-06-14

Brief Summary

Purpose of the Pilot Trial:

To determine the feasibility of conducting a multicentre randomized open label controlled trial evaluating the use of prophylactic dose rivaroxaban to prevent central venous catheter (CVC) associated venous thromboembolism (VTE) among cancer patients.

Hypothesis: treatment with low dose rivaroxaban (10mg) will reduce the incidence of upper extremity venous thrombosis in a high risk population with cancer and CVC.

Detailed Description

Design:

This is a pilot interventional study to be conducted at 2 Canadian Centres. The Ottawa Hospital and Juravinski Hospital. It is an open label randomized controlled trial.

Consenting participants, meeting eligibility criteria will be randomized at the time of enrollment to one of two groups.

Rivaroxaban 10mg by mouth daily x 90 (+/- 3) days OR Standard of Care

Participants in the treatment arm will have study drug dispensed at Day 1 and take medication for 90 days or until CVC is removed. Follow up visits (in person or phone) will occur at Day 30 (+/- 3 days) and Day 90 (+/- 3 days). Overall, participants will be followed for 3 months. Adverse events will be collected for the first 90 days.

Outcomes The primary feasibility outcome for the pilot study is the number of participants recruited per centre per month. We will obtain baseline details of the patient's type, location and treatment of cancer, comorbidities and medications. Secondary feasibility outcomes of the pilot study will include, consent rates, loss to follow up, adherence to therapy defining 80% or greater medication taken as having good adherence to study drug, proportion of screened patients who meet eligibility criteria.

Conditions

Upper Extremity Deep Vein Thrombosis; Central Venous Catheter Thrombosis; Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Rivaroxaban Thromboprophylaxis

Rivaroxaban 10 mg po daily for 90 days(+/- 3 days). After the Day - 90 follow up, the study treatment will be discontinued and subsequent treatment will be at the discretion of the attending physician.

Group Type: EXPERIMENTAL

Rivaroxaban 10 MG

Intervention Type: DRUG

Rivaroxaban 10mg po daily x 90 (+/- 3 days)

Standard of care

No rivaroxaban prophylaxis. Management will be at the discretion of the attending physician.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Rivaroxaban 10 MG

Rivaroxaban 10mg po daily x 90 (+/- 3 days)

Intervention Type: DRUG

Other Intervention Names

Xarelto 10mg tablet po daily

Eligibility Criteria

Inclusion Criteria

1.Patients 18 years of age or older with a new or existing diagnosis of cancer with a CVC inserted within the last 72 hours.

Exclusion Criteria

1. CVC in place for >72 hours

2. Patient requires anticoagulation for other indication

3. Concomitant use of dual antiplatelet therapy

4. Prior VTE

5. Major bleeding event in the last 6 weeks

6. Patient on concomitant medication with known interaction with rivaroxaban (eg. CYP3A4 inhibitor)

7. Pregnancy (documentation of use of effective contraception if sexually active or negative B-Hcg required)

8. Known renal failure, based on Creatinine clearance <30 mL/min (Cockcroft-Gault) (in the previous 3 months)

9. Documented severe liver disease (eg. acute clinical hepatitis, chronic active hepatitis, cirrhosis or ALT >3ULN) ( in the previous 3 months)

10. Known thrombocytopenia < 50x 109/L (in the previous 3 months)

11. Allergy to rivaroxaban

12. Life expectancy <6 months

13. History of condition at increased bleeding risk including, but not limited to:

1. Major surgical procedure or trauma within 30 days before the randomization visit

2. Clinically significant gastrointestinal bleeding within 6 months before the randomization visit

3. History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding

4. Chronic hemorrhagic disorder

5. Known intracranial neoplasm, arteriovenous malformation, or aneurysm

6. Sustained uncontrolled hypertension: systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg

14. Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin or acute leukemia or myelodysplastic syndrome

15. Geographic inaccessibility

16. Refused or unable to obtain consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen Elizabeth II Health Sciences Centre

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rick T Ikesaka, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute / Division of Hematology- The Ottawa Hospital

Locations

The Ottawa Hospital General Campus

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 34027291 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id