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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer Patients; Central Venous Catheter Thrombosis; Upper Extremity Thrombosis
• Intervention / Treatment: Drug: Apixaban

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 Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: Judy Kovacs, RN; Phone Number: 55148 519-685-8500; Email: judy.kovacs@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Recruiting
      • London Health Science Center, Victoria Hospital
      • Contact: Phone Number: 519-685-8500
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • Ottawa Hospital Research Institute
      • Contact: Anne Marie Clement; Phone Number: 613-737-8899

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cancer patients with central venous catheter associated deep vein thrombosis in the upper extremity

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Michael Kovacs
• Collaborators: Ottawa Hospital Research Institute; Jewish General Hospital
• Investigators: Principal Investigator: Michael Kovacs, Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: July 30, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Upper Extremity Deep Vein Thrombosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Apixaban
• Other Study ID Numbers: R-17-160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No