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Trial record 71 of 591 for:    Recruiting, Not yet recruiting, Available Studies | Superior

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

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ClinicalTrials.gov Identifier: NCT03100071
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : February 28, 2019
Sponsor:
Collaborators:
Ottawa Hospital Research Institute
Jewish General Hospital
Information provided by (Responsible Party):
Michael Kovacs, Lawson Health Research Institute

Tracking Information
First Submitted Date March 29, 2017
First Posted Date April 4, 2017
Last Update Posted Date February 28, 2019
Actual Study Start Date May 15, 2017
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 4, 2017)
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)
Original Primary Outcome Measures
 (submitted: March 29, 2017)
Central Line Failure [ Time Frame: within 3 months of study follow-up ]
Infusion failure that does not respond to 2 mg tPA
Change History Complete list of historical versions of study NCT03100071 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 4, 2017)
  • Recurrent Venous Thromboembolism (VTE) [ Time Frame: within 3 months of study follow-up ]
    recurrence of blood clot either in leg or lung or both
  • Bleeding [ Time Frame: within 3 months of study follow-up ]
    Major bleeding, clinically relevant minor bleed, death, time to central line failure
Original Secondary Outcome Measures
 (submitted: March 29, 2017)
  • Recurrent VTE [ Time Frame: within 3 months of study follow-up ]
    recurrence of blood clot either in leg or lung or both
  • Bleeding [ Time Frame: within 3 months of study follow-up ]
    Major bleeding, clinically relevant minor bleed, death, time to central line failure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) in Cancer Patients
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)
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Cancer patients with central venous catheter associated deep vein thrombosis in the upper extremity
Condition
  • Cancer Patients
  • Central Venous Catheter Thrombosis
  • Upper Extremity Thrombosis
Intervention Drug: Apixaban
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.
Other Name: Eliquis
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 29, 2017)
70
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Luljeta Pallaveshi 519-685-8500 ext 55148 Luljeta.Pallaveshi@lhsc.on.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03100071
Other Study ID Numbers R-17-160
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Michael Kovacs, Lawson Health Research Institute
Study Sponsor Michael Kovacs
Collaborators
  • Ottawa Hospital Research Institute
  • Jewish General Hospital
Investigators
Principal Investigator: Michael Kovacs Lawson Health Research Institute
PRS Account Lawson Health Research Institute
Verification Date February 2019