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Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines (TRIM-Line)

Primary Purpose

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

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Rivaroxaban 10 MG

About this trial

This is an interventional prevention trial for Upper Extremity Deep Vein Thrombosis focused on measuring Upper Extremity Deep Vein Thrombosis, Thromboprophylaxis, Cancer, Randomized Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

CVC in place for >72 hours
Patient requires anticoagulation for other indication
Concomitant use of dual antiplatelet therapy
Prior VTE
Major bleeding event in the last 6 weeks
Patient on concomitant medication with known interaction with rivaroxaban (eg. CYP3A4 inhibitor)
Pregnancy (documentation of use of effective contraception if sexually active or negative B-Hcg required)
Known renal failure, based on Creatinine clearance <30 mL/min (Cockcroft-Gault) (in the previous 3 months)
Documented severe liver disease (eg. acute clinical hepatitis, chronic active hepatitis, cirrhosis or ALT >3ULN) ( in the previous 3 months)
Known thrombocytopenia < 50x 109/L (in the previous 3 months)
Allergy to rivaroxaban
Life expectancy <6 months
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
Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin or acute leukemia or myelodysplastic syndrome
Geographic inaccessibility
Refused or unable to obtain consent

Sites / Locations

The Ottawa Hospital General Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rivaroxaban Thromboprophylaxis

Standard of care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Pilot Feasibility Outcome- Enrolment

Number of Participants recruited per centre per month

Secondary Outcome Measures

Consent rate

Proportion of approached patients who consent to enter study.

Loss to follow up

During the 90 (+/-3) days of the trial

Adherence to Therapy

Good adherence defined as 80% or greater study medication taken

Proportion of screened patients which meet eligibility criteria

Full Information

NCT ID

NCT03506815

First Posted

March 19, 2018

Last Updated

July 22, 2020

Sponsor

Ottawa Hospital Research Institute

Collaborators

Queen Elizabeth II Health Sciences Centre, University of Alberta, Hamilton Health Sciences Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03506815

Brief Title

Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines

Acronym

TRIM-Line

Official Title

A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Investigating Primary Thromboprophylaxis With Rivaroxaban in Patients With Malignancy and Central Venous Catheters

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

March 15, 2019 (Actual)

Primary Completion Date

May 14, 2020 (Actual)

Study Completion Date

June 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ottawa Hospital Research Institute

Collaborators

Queen Elizabeth II Health Sciences Centre, University of Alberta, Hamilton Health Sciences Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Purpose of 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. Design: This is a pilot interventional study to be conducted at 3 Canadian Centres. The Ottawa Hospital, QEII Health Science Centre and University of Alberta 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 po 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. Follow up visits (in person or phone) will occur at Day 30 (+/- 3 days) and Day 90 (+/- 3 days) month and 3 months post enrollment. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Upper Extremity Deep Vein Thrombosis, Thromboprophylaxis, Cancer, Randomized Trial

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Randomized Pilot Trial comparing two groups - Rivaroxaban 10mg po daily x90 days vs standard of care(usual treatment)

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rivaroxaban Thromboprophylaxis

Arm Type

Experimental

Arm Description

Arm Title

Standard of care

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Rivaroxaban 10 MG

Other Intervention Name(s)

Xarelto 10mg tablet po daily

Intervention Description

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

Primary Outcome Measure Information:

Title

Pilot Feasibility Outcome- Enrolment

Description

Number of Participants recruited per centre per month

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Consent rate

Description

Proportion of approached patients who consent to enter study.

Time Frame

6 months

Title

Loss to follow up

Description

During the 90 (+/-3) days of the trial

Time Frame

6 months

Title

Adherence to Therapy

Description

Good adherence defined as 80% or greater study medication taken

Time Frame

6 months

Title

Proportion of screened patients which meet eligibility criteria

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: CVC in place for >72 hours Patient requires anticoagulation for other indication Concomitant use of dual antiplatelet therapy Prior VTE Major bleeding event in the last 6 weeks Patient on concomitant medication with known interaction with rivaroxaban (eg. CYP3A4 inhibitor) Pregnancy (documentation of use of effective contraception if sexually active or negative B-Hcg required) Known renal failure, based on Creatinine clearance <30 mL/min (Cockcroft-Gault) (in the previous 3 months) Documented severe liver disease (eg. acute clinical hepatitis, chronic active hepatitis, cirrhosis or ALT >3ULN) ( in the previous 3 months) Known thrombocytopenia < 50x 109/L (in the previous 3 months) Allergy to rivaroxaban Life expectancy <6 months History of condition at increased bleeding risk including, but not limited to: Major surgical procedure or trauma within 30 days before the randomization visit Clinically significant gastrointestinal bleeding within 6 months before the randomization visit History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding Chronic hemorrhagic disorder Known intracranial neoplasm, arteriovenous malformation, or aneurysm Sustained uncontrolled hypertension: systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin or acute leukemia or myelodysplastic syndrome Geographic inaccessibility Refused or unable to obtain consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rick T Ikesaka, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Ottawa Hospital General Campus

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Pilot Feasibility Study- no current plan to share IPD

Citations:

PubMed Identifier

34027291

Citation

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.

Results Reference

derived

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Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines

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