Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) in Cancer Patients
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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.
Condition or disease
Cancer PatientsCentral Venous Catheter ThrombosisUpper Extremity Thrombosis
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.
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)
Actual Study Start Date :
May 15, 2017
Estimated Primary Completion Date :
December 30, 2019
Estimated Study Completion Date :
December 31, 2019
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Cancer patients with central venous catheter associated deep vein thrombosis in the upper extremity
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.
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