NCT03100071

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 15, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

August 3, 2021

Status Verified

July 1, 2021

Enrollment Period

4.2 years

First QC Date

March 29, 2017

Last Update Submit

July 30, 2021

Conditions

Cancer PatientsCentral Venous Catheter ThrombosisUpper Extremity Thrombosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Recurrent Venous Thromboembolism (VTE)

    within 3 months of study follow-up

  • Bleeding

    within 3 months of study follow-up

Interventions

ApixabanDRUG

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

London Health Science Center, Victoria Hospital

London, Ontario, N6A 5W9, Canada

RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

MeSH Terms

Conditions

Upper Extremity Deep Vein Thrombosis

Interventions

apixaban

Condition Hierarchy (Ancestors)

Venous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Michael Kovacs

    London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Judy Kovacs, RN

CONTACT

519-685-8500judy.kovacs@lhsc.on.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Medical Doctor

Study Record Dates

First Submitted

March 29, 2017

First Posted

April 4, 2017

Study Start

May 15, 2017

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

August 3, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)