Last updated: July 30, 2021
Sponsor: Michael Kovacs
Overall Status: Active - Recruiting
Phase
N/A
Condition
Venous Thrombosis
Thrombosis
Venous Thromboembolism
Treatment
N/AClinical Study ID
NCT03100071
R-17-160
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female > 18 years of age.
- Symptomatic acute upper limb thrombosis in the axillary, subclavian or internaljugular veins, with or without pulmonary embolism, associated with central venouscatheter objectively documented by compression ultrasonography, venogram orComputerized Tomography (CT) scan.
- Diagnosis of active malignancy, as defined by patients who are either receiving activetreatment, or have metastatic disease or who have been diagnosed within the past twoyears.
- Willing to provide written informed consent.
Exclusion
Exclusion Criteria:
- Presence of dialysis catheters
- Active bleeding or high risk for major bleeding
- Platelet Count < 75 x 109/L
- Creatinine Clearance < 30 mL/min
- Currently on other anticoagulant with therapeutic intent for another indication
- Pulmonary embolism accompanied by hemodynamic instability or oxygen requirement
- Inability to infuse through the catheter after a trial of intraluminal thrombolytictherapy (2 mg tPA).
- Patients with Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL) ormultiple myeloma with a bone marrow or stem cell transplant planned within the next 3months
- Treatment for current episode > 7 days with any acceptable anticoagulant therapy
- Concomitant use of p-glucoprotein and Cytochrome P450 3A4 (CYP3A4) inhibitors (forexample azole antifungals such as ketoconazole) or inducers (for example rifampicin,antiepileptics)
- Recent coronary artery stent requiring dual anti-platelet therapy (for exampleacetylsalicylic acid [ASA] and Plavix)
- If female of childbearing potential: pregnancy and/or breastfeeding
Study Design
Total Participants: 70
Study Start date:
May 15, 2017
Estimated Completion Date:
August 31, 2021
Study Description
Connect with a study center
London Health Science Center, Victoria Hospital
London, Ontario N6A 5W9
CanadaActive - Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario K1H 8L6
CanadaActive - Recruiting
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