CClinicalTrials.gg
Status unknownNCT03100071Updated Aug 3, 2021

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

An observational study in Cancer Patients, Central Venous Catheter Thrombosis and Upper Extremity Thrombosis, sponsored by Michael Kovacs. Status unknown at 2 sites in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-03.

Sponsored by Michael Kovacs · Observational

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Cancer Patients
  • Central Venous Catheter Thrombosis
  • Upper Extremity Thrombosis
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In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's planned enrollment of 70 is below the median of 213 across 586 observational studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

This is the only study on the registry with Michael Kovacs as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No

Interventions

  • DrugApixaban

    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.

    Also known as: Eliquis

06

What researchers measure

Primary outcomes

  1. Central Line Failure

    Infusion failure that does not respond to 2 milligram (mg) tissue Plasminogen Activator (tPA)

    Time frame: within 3 months of study follow-up

Secondary outcomes

  1. Recurrent Venous Thromboembolism (VTE)

    recurrence of blood clot either in leg or lung or both

    Time frame: within 3 months of study follow-up

  2. Bleeding

    Major bleeding, clinically relevant minor bleed, death, time to central line failure

    Time frame: within 3 months of study follow-up

07

Study locations

2 of 2 sites recruiting
  • London Health Science Center, Victoria Hospital
    London, Ontario N6A 5W9, Canada
    • · Contact · 519-685-8500
    Recruiting
  • Ottawa Hospital Research Institute
    Ottawa, Ontario K1H 8L6, Canada
    • Anne Marie Clement · Contact · 613-737-8899
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03100071
Lead sponsor
Michael Kovacs
Collaborators
Ottawa Hospital Research Institute, Jewish General Hospital
Responsible party
Michael Kovacs (Associate Professor, Medical Doctor, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's) — Sponsor-investigator
First posted
Apr 4, 2017
Start date
May 15, 2017
Primary completion
Aug 2021 (estimated)
Completion
Aug 2021 (estimated)
Last update
Aug 3, 2021

Study contacts

Judy Kovacs, RN
Contact
judy.kovacs@lhsc.on.ca
519-685-8500 ext. 55148
Michael Kovacs
principal investigator · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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