Heart and Blood Diseases

All Conditions

Thrombosis

Venous Thrombosis

Upper Extremity Deep Vein Thrombosis

Embolism

Embolism and Thrombosis

Vascular Diseases

Anticoagulants

All Drugs and Chemicals

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Amino Acids

Rivaroxaban

Factor Xa Inhibitors

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Enzyme Inhibitors

Serine

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.

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

Rivaroxaban 10 MG

Rick T Ikesaka, MD

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.

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

Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines

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

Pilot Feasibility Study- no current plan to share IPD

Number of Participants recruited per centre per month

Proportion of approached patients who consent to enter study.

Good adherence defined as 80% or greater study medication taken

Queen Elizabeth II Health Sciences Centre

University of Alberta

Hamilton Health Sciences Corporation

Ottawa Hospital Research Institute

Infections

Neoplasms

Blood and Lymph Conditions

Symptoms and General Pathology

Hematologic Neoplasms

Communicable Diseases

Sepsis

Toxemia

Hematologic Diseases

Syndrome

Systemic Inflammatory Response Syndrome

Inflammation

collection and descriptionof central venous catheter-related complications

central venous catheter

Florence OBERKAMPF

Oncology and hemotology patients under anticancer treatments are exposed to increased risks of central venous catheter-related complications due to the underlying cancer and its treament.

This prospective observational monocentric french study aims at describing the incidence of such complications, their morbimortality, and analyzing some risk factors in order to contribute to propose some strategies to reduce these complications' rate and consequences

Central Venous Catheter-related Complications in Patients Under Anticancer Treatment

Central Venous Catheter-related Complications in Patients Under Anticancer Treatment: a Prospective Monocentric Study on Incidence and Consequences

Centre Hospitalier Alpes Leman

Body Weight

Fibrinolytic Agents

Heparin

Apixaban

Calcium heparin

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

Patients will be treated with Low Molecular Weight Heparin (LMWH) for 1 week and then with apixaban 5 milligram (mg) twice daily for 11 weeks.

Judy Kovacs, RN

Anne Marie Clement

Michael Kovacs

Cancer patients with Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) will be treated with Low Molecular Weight Heparin (LMWH) and apixaban. Study duration is 12 weeks.

Cancer patients who have developed blood clot in the arm that has the central venous catheter will be treated with standard of care blood thinning injection of low molecular weight heparin for 1 week and then for apixaban 5 mg twice daily for the rest of 11 weeks. Data will be collected to see if the central venous catheter "survived" or remained in place and did not have to be taken out because of the clot.

Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) in Cancer Patients

A Pilot Study in Cancer Patients With Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) in the Upper Extremity Treated With Low Molecular Weight Heparin (LMWH) and Apixaban (Catheter 3)

Infusion failure that does not respond to 2 milligram (mg) tissue Plasminogen Activator (tPA)

recurrence of blood clot either in leg or lung or both

Major bleeding, clinically relevant minor bleed, death, time to central line failure

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines	NCT03506815	Upper Extremity... Central Venous ... Cancer	Rivaroxaban 10 ...	18 Years -	Ottawa Hospital Research Institute
Central Venous Catheter-related Complications in Patients Under Anticancer Treatment	NCT05455866	Central Venous ... Central Venous ... Solid Tumor Hematologic Mal...	central venous ...	18 Years -	Centre Hospitalier Alpes Leman
Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) in Cancer Patients	NCT03100071	Cancer Patients Central Venous ... Upper Extremity...	Apixaban	18 Years -	Lawson Health Research Institute
Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) in Cancer Patients	NCT03100071	Cancer Patients Central Venous ... Upper Extremity...	Apixaban	18 Years -	Lawson Health Research Institute

Spots Global Cancer Trial Database for central venous catheter thrombosis