Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) in Cancer Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Central Line Failure [within 3 months of study follow-up]
Infusion failure that does not respond to 2 milligram (mg) tissue Plasminogen Activator (tPA)
Secondary Outcome Measures
- Recurrent Venous Thromboembolism (VTE) [within 3 months of study follow-up]
recurrence of blood clot either in leg or lung or both
- Bleeding [within 3 months of study follow-up]
Major bleeding, clinically relevant minor bleed, death, time to central line failure
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female > 18 years of age.
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Symptomatic acute upper limb thrombosis in the axillary, subclavian or internal jugular veins, with or without pulmonary embolism, associated with central venous catheter objectively documented by compression ultrasonography, venogram or Computerized Tomography (CT) scan.
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Diagnosis of active malignancy, as defined by patients who are either receiving active treatment, or have metastatic disease or who have been diagnosed within the past two years.
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Willing to provide written informed consent.
Exclusion Criteria:
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Presence of dialysis catheters
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Active bleeding or high risk for major bleeding
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Platelet Count < 75 x 109/L
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Creatinine Clearance < 30 mL/min
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Currently on other anticoagulant with therapeutic intent for another indication
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Pulmonary embolism accompanied by hemodynamic instability or oxygen requirement
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Inability to infuse through the catheter after a trial of intraluminal thrombolytic therapy (2 mg tPA).
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Patients with Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL) or multiple myeloma with a bone marrow or stem cell transplant planned within the next 3 months
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Treatment for current episode > 7 days with any acceptable anticoagulant therapy
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Concomitant use of p-glucoprotein and Cytochrome P450 3A4 (CYP3A4) inhibitors (for example azole antifungals such as ketoconazole) or inducers (for example rifampicin, antiepileptics)
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Recent coronary artery stent requiring dual anti-platelet therapy (for example acetylsalicylic acid [ASA] and Plavix)
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If female of childbearing potential: pregnancy and/or breastfeeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | London Health Science Center, Victoria Hospital | London | Ontario | Canada | N6A 5W9 |
| 2 | Ottawa Hospital Research Institute | Ottawa | Ontario | Canada | K1H 8L6 |
Sponsors and Collaborators
- Michael Kovacs
- Ottawa Hospital Research Institute
- Jewish General Hospital
Investigators
- Principal Investigator: Michael Kovacs, Lawson Health Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R-17-160