Cancer PatientsNCT03100071
Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) in Cancer Patients
An observational study of Cancer Patients and Central Venous Catheter Thrombosis, run by Michael Kovacs at 2 sites in Canada.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Patients, Central Venous Catheter Thrombosis, Upper Extremity Thrombosis
- What is being tested?
- Apixaban
- How many people
- 70 participants
- Where
- 2 sitesCanada
- Study dates
- 15 May 2017to Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cancer patients with central venous catheter associated deep vein thrombosis in the upper extremity
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
London Health Science Center, Victoria Hospital
London, Ontario, N6A 5W9
519-685-8500
- Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
Anne Marie Clement, 613-737-8899
About this study
Official title: 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.
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.
- Being tested
- Apixaban
- Medical subject headings
- Upper Extremity Deep Vein Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called Eliquis
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Line Failure
Infusion failure that does not respond to 2 milligram (mg) tissue Plasminogen Activator (tPA)
Measured: within 3 months of study follow-up
Secondary outcomes (2)
Recurrent Venous Thromboembolism (VTE)
recurrence of blood clot either in leg or lung or both
Measured: within 3 months of study follow-up
Bleeding
Major bleeding, clinically relevant minor bleed, death, time to central line failure
Measured: within 3 months of study follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start15 May 2017
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Kovacs
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Hospital Research Institute, Jewish General Hospital
- Responsible party
- Sponsor-investigator, Michael Kovacs, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Michael Kovacs, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100071
- Sponsor's protocol ID
- R-17-160
- Status last verified
- Jul 2021
- First submitted
- 29 Mar 2017
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03100071
- Acronym / sponsor ID
- R-17-160
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Michael KovacsUniversity, hospital or other
- Collaborators
- Ottawa Hospital Research Institute, Jewish General Hospital
- Study start
- 15 May 2017 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients with central venous catheter associated deep vein thrombosis in the upper extremity
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApixabanAlso: EliquisPatients will be treated with Low Molecular Weight Heparin (LMWH) for 1 week and then with apixaban 5 milligram (mg) twice daily for 11 weeks. | Drug | – |
Primary outcome
Central Line Failure
Time frame: within 3 months of study follow-up
Infusion failure that does not respond to 2 milligram (mg) tissue Plasminogen Activator (tPA)
2 secondary outcomes
Recurrent Venous Thromboembolism (VTE)
Time frame: within 3 months of study follow-up
Bleeding
Time frame: within 3 months of study follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kovacs principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Patients and Central Venous Catheter Thrombosis, run by Michael Kovacs at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judy Kovacs, RN (519-685-8500 ext. 55148, judy.kovacs@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Line Failure (time frame: within 3 months of study follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.