A Phase 3 interventional study of Rivaroxaban 10 MG in Upper Extremity Deep Vein Thrombosis, Central Venous Catheter Thrombosis and Cancer, sponsored by Ottawa Hospital Research Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by Ottawa Hospital Research Institute · Phase 3, Interventional, and Prevention
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.
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.
1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.
This study's enrollment of 105 is close to the median of 106 across 849 interventional studies indexed under Thrombosis.
Browse Thrombosis studies →Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
History of condition at increased bleeding risk including, but not limited to:
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.
Drug: Rivaroxaban 10 MG
No rivaroxaban prophylaxis. Management will be at the discretion of the attending physician.
Rivaroxaban 10mg po daily x 90 (+/- 3 days)
Also known as: Xarelto 10mg tablet po daily
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.
Time frame: 12 months
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.
Time frame: 90 days
Number of Participants With Thrombotic Complication
Thrombotic complication was defined as a combination of major venous thromboembolism (VTE); any symptomatic or incidentally detected proximal deep vein thrombosis (DVT) of the lower or upper limbs, any nonfatal symptomatic or incidental pulmonary embolism (PE), and pulmonary embolism-related death) and any other deep (ie, distal, splanchnic, or cerebral) or superficial venous thrombosis.
Time frame: 90 days
Number of Participants With CVC-Related Complication
Central venous catheter (CVC) occlusion was defined as an obstruction of the CVC lumen that prevents or limits the ability to flush, withdraw blood, and/or administer solutions or medications
Time frame: 90 days
Number of Participants With Major Bleeding
Defined by the International Society on Thrombosis and Haemostasis (ISTH) as overt bleeding associated with a decrease in the hemoglobin level of ≥2 g/dL, which led to transfusion of two or more units of packed red blood cells, occurred in a critical site, or contributed to death.
Time frame: 90 days
Number of Participants With Clinically Relevant Non-Major Bleed
Clinically relevant non-major bleeding, as per the standardized definition by the ISTH, is any signs or symptoms of hemorrhage not meeting criteria for major bleeding but associated with medical intervention, unscheduled in-person contact with a healthcare professional or need for hospitalization or increased level of care.
Time frame: 90 days
| Milestone | Rivaroxaban Thromboprophylaxis | Standard of Care |
|---|---|---|
| Started | 52 | 53 |
| Completed | 37 | 53 |
| Not completed | 15 | 0 |
| Withdrew: Adverse event | 8 | 0 |
| Withdrew: End of chemotherapy removal of peripherally inserted central venous catheter | 5 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Elective surgery | 1 | 0 |
A convenience sample size of 100 patients was chosen to allow reporting of the average monthly recruitment.
| Average enrolment rate/month/site | Site 1 | Site 2 |
|---|---|---|
| Primary Feasibility Outcome - Number of Participants Recruited Per Month | 7.5 | 2.0 |
Good adherence defined as 80% or greater study medication taken in patients randomized to receive Rivaroxaban thromboprophylaxis.
| percentage of participants | Rivaroxaban Thromboprophylaxis | Standard of Care |
|---|---|---|
| Secondary Feasibility Outcomes - Percentage of Participants With Good Adherence to Therapy | 96.7 | — |
Thrombotic complication was defined as a combination of major venous thromboembolism (VTE); any symptomatic or incidentally detected proximal deep vein thrombosis (DVT) of the lower or upper limbs, any nonfatal symptomatic or incidental pulmonary embolism (PE), and pulmonary embolism-related death) and any other deep (ie, distal, splanchnic, or cerebral) or superficial venous thrombosis.
| Participants | Rivaroxaban Thromboprophylaxis | Standard of Care |
|---|---|---|
| Major VTE | 2 | 3 |
| Major VTE - Upper extremity | 2 | 2 |
| Major VTE - PE | 0 | 1 |
| Other thrombotic event - splanchnic vein thrombosis | 1 | 1 |
| Other thrombotic event - superficial vein thrombosis | 0 | 1 |
Central venous catheter (CVC) occlusion was defined as an obstruction of the CVC lumen that prevents or limits the ability to flush, withdraw blood, and/or administer solutions or medications
| Participants | Rivaroxaban Thromboprophylaxis | Standard of Care |
|---|---|---|
| CVC-associated infection | 0 | 2 |
| CVC migration | 0 | 1 |
| CVC positional occlusion | 0 | 1 |
| CVC occlusion | 0 | 1 |
Defined by the International Society on Thrombosis and Haemostasis (ISTH) as overt bleeding associated with a decrease in the hemoglobin level of ≥2 g/dL, which led to transfusion of two or more units of packed red blood cells, occurred in a critical site, or contributed to death.
| Participants | Rivaroxaban Thromboprophylaxis | Standard of Care |
|---|---|---|
| Number of Participants With Major Bleeding | 1 | 0 |
Clinically relevant non-major bleeding, as per the standardized definition by the ISTH, is any signs or symptoms of hemorrhage not meeting criteria for major bleeding but associated with medical intervention, unscheduled in-person contact with a healthcare professional or need for hospitalization or increased level of care.
| Participants | Rivaroxaban Thromboprophylaxis | Standard of Care |
|---|---|---|
| Number of Participants With Clinically Relevant Non-Major Bleed | 2 | 2 |
Collected over 3 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rivaroxaban Thromboprophylaxis | 0/52 (0%) | 11/52 (21.2%) | 16/52 (30.8%) |
| Standard of Care | 0/53 (0%) | 10/53 (18.9%) | 12/53 (22.6%) |
| Event | Rivaroxaban Thromboprophylaxis | Standard of Care |
|---|---|---|
| Febrile NeutropeniaBlood and lymphatic system disorders | 1/1 | 0/53 |
| FeverImmune system disorders | 3/52 | 0/53 |
| Small Bowel ObstructionGastrointestinal disorders | 3/52 | 0/53 |
| PnemoniaRespiratory, thoracic and mediastinal disorders | 1/52 | 2/53 |
| Major BleedGastrointestinal disorders | 1/52 | 0/53 |
| Shortness of BreathRespiratory, thoracic and mediastinal disorders | 1/52 | 1/53 |
| Decreased O2Respiratory, thoracic and mediastinal disorders | 1/52 | 0/53 |
| Chest PainGeneral disorders | 0/52 | 1/53 |
| UlcerSkin and subcutaneous tissue disorders | 0/52 | 1/53 |
| E-Coli, Urinary Tract InfectionInfections and infestations | 0/52 | 1/53 |
| Event | Rivaroxaban Thromboprophylaxis | Standard of Care |
|---|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 5/52 | 2/53 |
| FeverGeneral disorders | 2/52 | 1/53 |
| IndigestionGastrointestinal disorders | 2/52 | 0/53 |
| RashSkin and subcutaneous tissue disorders | 2/52 | 1/53 |
| Symptomatic AnemiaBlood and lymphatic system disorders | 0/52 | 2/53 |
| AnemiaBlood and lymphatic system disorders | 1/52 | 1/53 |
| Common ColdGeneral disorders | 1/52 | 0/53 |
| Chemotherapy Infusion ReactionInjury, poisoning and procedural complications | 1/52 | 1/53 |
| Chest painGeneral disorders | 1/52 | 1/53 |
| Lower back painMusculoskeletal and connective tissue disorders | 1/52 | 0/53 |
| Age, Continuous(years) | Rivaroxaban Thromboprophylaxis | Standard of Care | Total |
|---|---|---|---|
| Mean | 60 ± 11.9 | 61.6 ± 12.7 | 60.8 ± 12.3 |
| Sex: Female, Male(Participants) | Rivaroxaban Thromboprophylaxis | Standard of Care | Total |
|---|---|---|---|
| Female | 36 | 36 | 72 |
| Male | 16 | 17 | 33 |
| Race/Ethnicity, Customized(Participants) | Rivaroxaban Thromboprophylaxis | Standard of Care | Total |
|---|---|---|---|
| White | 50 | 49 | 99 |
| Black | 0 | 1 | 1 |
| Asian | 0 | 3 | 3 |
| Other | 2 | 0 | 2 |
| Cancer type(Participants) | Rivaroxaban Thromboprophylaxis | Standard of Care | Total |
|---|---|---|---|
| Breast | 15 | 14 | 29 |
| Colorectal | 15 | 16 | 31 |
| Stomach | 5 | 2 | 7 |
| Gynecological | 6 | 5 | 11 |
| Pancreas | 3 | 7 | 10 |
| Other | 8 | 9 | 17 |
| Central Venous Catheter Type(Participants) | Rivaroxaban Thromboprophylaxis | Standard of Care | Total |
|---|---|---|---|
| PICC | 40 | 42 | 82 |
| Port-a-Cath | 12 | 11 | 23 |
| Metastatic disease(Participants) | Rivaroxaban Thromboprophylaxis | Standard of Care | Total |
|---|---|---|---|
| Count of participants | 14 | 19 | 33 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Pilot Feasibility Study- no current plan to share individual participant data
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Ottawa Hospital Research Institute