Central Venous Catheter (CVC) Associated Deep Vein Thromb... | NCT03100071

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

NCT03100071

Sponsor

Michael Kovacs

Status

Unknown status

Last Update Posted

Aug 3, 2021Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Cancer Patients
Central Venous Catheter Thrombosis
Upper Extremity Thrombosis

Interventions

Apixaban

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2017Actual

Primary Completion Date

Aug 2021Estimated

Completion Date

Aug 2021Estimated

First Submitted Date

Mar 29, 2017

First Submission Date that Met QC Criteria

Mar 29, 2017

First Posted Date

Apr 4, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2021

Last Update Posted Date

Aug 3, 2021Actual

Name	Class
Ottawa Hospital Research Institute	OTHER
Jewish General Hospital	OTHER

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Name	Type	Description	Arm Group Labels	Other Names
Apixaban	Drug	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.		Eliquis

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Judy Kovacs, RN	Contact	519-685-8500	55148	judy.kovacs@lhsc.on.ca

Overall Officials

Name	Affiliation	Role
Michael Kovacs	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
London Health Science Center, Victoria Hospital	Recruiting	London	Ontario	N6A 5W9	Canada

ID	Term
D020246	Venous Thrombosis
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases