Upper Extremity Deep Vein ThrombosisPhase 3TRIM-LineNCT03506815
Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines
A Phase 3 study testing Rivaroxaban 10 MG in people with Upper Extremity Deep Vein Thrombosis and Central Venous Catheter Thrombosis, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Extremity Deep Vein Thrombosis, Central Venous Catheter Thrombosis, Cancer
- What is being tested?
- Rivaroxaban 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteCanada
- Study dates
- 15 Mar 2019to 14 Jun 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Rivaroxaban 10 MG
- Keywords
- Upper Extremity Deep Vein Thrombosis, Thromboprophylaxis, Cancer, Randomized Trial
- Medical subject headings
- Upper Extremity Deep Vein Thrombosis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 10 MGDrug
Also called Xarelto 10mg tablet po daily
Rivaroxaban 10mg po daily x 90 (+/- 3 days)
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban Thromboprophylaxis | Experimental | 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. Receives: Drug: Rivaroxaban 10 MG |
| Standard of care | No intervention | No rivaroxaban prophylaxis. Management will be at the discretion of the attending physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Feasibility Outcome - Number of Participants Recruited Per Month
A convenience sample size of 100 patients was chosen to allow reporting of the average monthly recruitment.
Measured: 12 months
Secondary outcomes (1)
Secondary Feasibility Outcomes - Percentage of Participants With Good Adherence to Therapy
Good adherence defined as 80% or greater study medication taken in patients randomized to receive Rivaroxaban thromboprophylaxis.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start15 Mar 2019
- Primary completion14 May 2020
- Study completion14 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Extremity Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Pilot Trial comparing two groups - Rivaroxaban 10mg po daily for 90 days vs standard of care (usual treatment)
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Elizabeth II Health Sciences Centre, University of Alberta, Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Rick T Ikesaka, MD, Principal investigator, Ottawa Hospital Research Institute / Division of Hematology- The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506815
- Sponsor's protocol ID
- 001
- Acronym
- TRIM-Line
- Status last verified
- Jan 2023
- First submitted
- 19 Mar 2018
- Last updated
- 5 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pilot Feasibility Study- no current plan to share individual participant data
Publications
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.
PubMed 34027291
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03506815
- Acronym / sponsor ID
- TRIM-Line / 001
- Keywords
- Upper Extremity Deep Vein Thrombosis, Thromboprophylaxis, Cancer, Randomized Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Queen Elizabeth II Health Sciences Centre, University of Alberta, Hamilton Health Sciences Corporation
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 14 Jun 2020 (actual)
- First posted
- 24 Apr 2018 (actual)
- Results
- Posted 5 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Pilot Trial comparing two groups - Rivaroxaban 10mg po daily for 90 days vs standard of care (usual treatment)
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban Thromboprophylaxis | Experimental | Drug: Rivaroxaban 10 MGRivaroxaban 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. |
| Standard of care | No intervention | –No rivaroxaban prophylaxis. Management will be at the discretion of the attending physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban 10 MGAlso: Xarelto 10mg tablet po dailyRivaroxaban 10mg po daily x 90 (+/- 3 days) | Drug | Rivaroxaban Thromboprophylaxis |
Primary outcome
Primary Feasibility Outcome - Number of Participants Recruited Per Month
Time frame: 12 months
A convenience sample size of 100 patients was chosen to allow reporting of the average monthly recruitment.
1 secondary outcome
Secondary Feasibility Outcomes - Percentage of Participants With Good Adherence to Therapy
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34027291Ikesaka 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.
- Individual participant dataSharing planned: No. Pilot Feasibility Study- no current plan to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rick T Ikesaka, MD principal investigator
Ottawa Hospital Research Institute / Division of Hematology- The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivaroxaban 10 MG in people with Upper Extremity Deep Vein Thrombosis and Central Venous Catheter Thrombosis, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Feasibility Outcome - Number of Participants Recruited Per Month (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03506815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.