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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Cancer Patients, Central Venous Catheter Thrombosis, Upper Extremity Thrombosis

Intervention / Treatment
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* Drug: Apixaban


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female > 18 years of age. 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. 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. Willing to provide written informed consent. 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 thrombolytic therapy (2 mg tPA). 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 Treatment for current episode > 7 days with any acceptable anticoagulant therapy Concomitant use of p-glucoprotein and Cytochrome P450 3A4 (CYP3A4) inhibitors (for example azole antifungals such as ketoconazole) or inducers (for example rifampicin, antiepileptics) Recent coronary artery stent requiring dual anti-platelet therapy (for example acetylsalicylic acid [ASA] and Plavix) If female of childbearing potential: pregnancy and/or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Apixaban|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Line Failure | Infusion failure that does not respond to 2 milligram (mg) tissue Plasminogen Activator (tPA) | within 3 months of study follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent Venous Thromboembolism (VTE) | recurrence of blood clot either in leg or lung or both | within 3 months of study follow-up | 
| Bleeding | Major bleeding, clinically relevant minor bleed, death, time to central line failure | within 3 months of study follow-up |