Clinical trial NCT03100071: Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) in Cancer Patients
Official title: 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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer Patients
Central Venous Catheter Thrombosis
Upper Extremity Thrombosis
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Ottawa Hospital Research Institute
name: Jewish General Hospital
First posted: 2017-04-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients with central venous catheter associated deep vein thrombosis in the upper extremity

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female \> 18 years of age.
2. 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.
3. 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.
4. Willing to provide written informed consent.

Exclusion Criteria:

1. Presence of dialysis catheters
2. Active bleeding or high risk for major bleeding
3. Platelet Count \< 75 x 109/L
4. Creatinine Clearance \< 30 mL/min
5. Currently on other anticoagulant with therapeutic intent for another indication
6. Pulmonary embolism accompanied by hemodynamic instability or oxygen requirement
7. Inability to infuse through the catheter after a trial of intraluminal thrombolytic therapy (2 mg tPA).
8. 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
9. Treatment for current episode \> 7 days with any acceptable anticoagulant therapy
10. Concomitant use of p-glucoprotein and Cytochrome P450 3A4 (CYP3A4) inhibitors (for example azole antifungals such as ketoconazole) or inducers (for example rifampicin, antiepileptics)
11. Recent coronary artery stent requiring dual anti-platelet therapy (for example acetylsalicylic acid \[ASA\] and Plavix)
12. If female of childbearing potential: pregnancy and/or breastfeeding

Primary outcomes:
measure: Central Line Failure
timeFrame: within 3 months of study follow-up
Secondary outcomes:
measure: Recurrent Venous Thromboembolism (VTE)
timeFrame: within 3 months of study follow-up
measure: Bleeding
timeFrame: within 3 months of study follow-up
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Science Center, Victoria Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Michael Kovacs
role: PRINCIPAL_INVESTIGATOR
References: