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

• Conditions: Cancer Patients; Central Venous Catheter Thrombosis; Upper Extremity Thrombosis

• Registration Number: NCT03100071
• Lead Sponsor: Michael Kovacs

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.

Study Timeline

• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2017-03-29
• Study First Posted: 2017-04-04
• Study Start: 2017-05-15
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-30
• Primary Completion: 2021-08
• Study Completion: 2021-08
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

London Health Science Center, Victoria Hospital; 🇨🇦 London, Ontario, Canada

Ottawa Hospital Research Institute; 🇨🇦 Ottawa, Ontario, Canada