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Post-thrombotic Syndrome & Predictors of Recurrence in Catheter-related Thrombosis

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ClinicalTrials.gov Identifier: NCT01999179
Recruitment Status : Recruiting
First Posted : December 3, 2013
Last Update Posted : August 28, 2018
Sponsor:
Collaborators:
Blood Center of Wisconsin
Ohio State University
Information provided by (Responsible Party):
Lisa Baumann Kreuziger, Medical College of Wisconsin

Brief Summary:
The goal of the pilot study is to determine if a multicenter prospective cohort study of cancer patients with blood clots associated with catheters is feasible. Cancer patients with catheter-related thrombosis treated with one month of anticoagulation will be evaluated for for post-thrombotic syndrome. Laboratory biomarkers will be evaluated as predictors of recurrent thrombosis.

Condition or disease Intervention/treatment Phase
Venous Thrombosis Neoplasms Drug: Heparin, Low-Molecular-Weight, or direct oral anticoagulants Not Applicable

Detailed Description:
Participants may be referred for screening at Medical College of Wisconsin (MCW) in two possible mechanisms: participant contact study staff from information on Clinical Trials Science Institute (CTSI) FACT website or referral from treating Hematologist or Oncologist. At MCW, an EPIC report will be generated to identify people with catheter related thrombosis (CRT). The treating provider would then be contacted to determine if referral to the study was appropriate. Subjects at Ohio State University (OSU) will be referred from the treating Hematologist or Oncologist. A report generated in Epic will be used to identify people with CRT. The treating provider would then be contacted to determine if referral to the study was appropriate. Participants will be given printed information about the study or verbal explanation using the informational flyer. Verbal consent will be obtained to be screened for participation and contacted by study personnel. Screening will be completed by BloodCenter of Wisconsin (BCW) nurse coordinator. We aim to consent and enroll patients after diagnosis of catheter-related thrombosis and prior to catheter removal. Consent and enrollment (Visit 1) must occur prior to discontinuation of anticoagulation. Participants will be treated with either enoxaparin for one month following catheter removal, or direct oral anticoagulant treatment (apixaban, rivaroxaban, dabigatran, or edoxaban). Anticoagulation will be continued for 1 month after catheter removal. The minimum duration of anticoagulation will be one month and maximum duration is 7 months. The cost of enoxaparin will be the responsibility of the participant as use of the medication is part of routine care. Subjects will be contacted by telephone prior to discontinuation of anticoagulation to review study protocol, assess for bleeding, and see if any continuation rules apply and arrange for research visit 2 in the following 1-2 weeks. Visits 3 and 4 will occur 3 and 6 months after catheter removal, respectively. At visits 3 & 4, Medical history, cancer history, and medications will be updated. At each visit, participants will be assessed for post-thrombotic syndrome using the modified Villalta scale and functional limitation using the DASH questionnaire. At MCW, surveys will be administered by the research coordinator and/or Translational Research Unit (TRU) staff and physical examination will be completed by BCW nurse coordinator. At OSU, surveys will be administered by research coordinators and physical examination will be administered by research nurse coordinator. Laboratory samples will be obtained for MCW participants only.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pilot Study of Post-thrombotic Syndrome & Predictors of Recurrence in Cancer Patients With Catheter-related Thrombosis
Study Start Date : June 2014
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Heparin

Arm Intervention/treatment
low-molecular-weight heparin or direct oral anticoagulant

Enoxaparin 1 mg/kg subcutaneously every 12 hours for one month following catheter removal or alternate enoxaparin dose or interval based on anti-factor Xa testing that was obtained by clinical team.

Apixaban, rivaroxaban, dabigatran, or edoxaban at standard dosing per FDA package insert for direct oral anticoagulants.

Drug: Heparin, Low-Molecular-Weight, or direct oral anticoagulants
Cancer patients will be treated with enoxaparin 1 mg/kg subcutaneously every 12 hours for one month following catheter removal or alternate enoxaparin dose or interval based on anti-factor Xa testing obtained by the clinical team or either apixaban, rivaroxaban, dabigatran, edoxaban following a catheter related blood clot
Other Names:
  • enoxaparin
  • apixaban
  • rivaroxaban
  • dabigatran
  • edoxaban




Primary Outcome Measures :
  1. Number of cancer patients enrolled with catheter-related thrombosis treated with 1 month of anticoagulation [ Time Frame: 1 year ]
    Recruitment of 56 patients in 1 year and 80% completion of post-thrombotic syndrome assessments by enrolled patients


Secondary Outcome Measures :
  1. Number of plasma samples obtained for biomarker analysis to predict recurrent venous thrombosis [ Time Frame: 1 year ]
    Obtaining 80% of samples from enrolled patients


Other Outcome Measures:
  1. Incidence of post-thrombotic syndrome in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation [ Time Frame: 6 months after catheter removal ]
    <20% will have incidence of post-thrombotic syndrome 6 months after catheter removal

  2. Incidence of recurrent thrombosis in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation [ Time Frame: 6 months after catheter removal ]
    <20% will have incidence of post-thrombotic syndrome 6 months after catheter removal

  3. Incidence of major and clinically relevant non-major bleeding in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation [ Time Frame: 6 months after catheter removal ]
    <20% will have incidence of post-thrombotic syndrome 6 months after catheter removal



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Upper extremity venous thrombosis associated with an indwelling catheter documented by ultrasound, CT or venography
  • Current hematologic or solid tumor malignancy undergoing chemotherapy, surgery, radiation or hormonal therapy for malignancy.
  • >18 years of age
  • Platelet count >50,000
  • Creatinine clearance >30 ml/min
  • Ability to provide informed consent

Exclusion Criteria:

  • Underlying medical condition or chemotherapy requiring long-term anticoagulation
  • Known underlying higher risk thrombophilias including antiphospholipid antibody syndrome, antithrombin, protein C or protein S deficiencies, or homozygosity or compound heterozygosity for prothrombin G20210A or Factor V R506Q mutations.
  • Inability to remove venous catheter
  • Anticipated replacement of central venous catheter within 3 months
  • Major bleeding or clinically relevant non-major bleeding in the preceding 60 days
  • Participation in another clinical trial that requires anticoagulation
  • Use of anticoagulant other than low-molecular weight heparin
  • Treatment with thrombolysis
  • Catheter removal >1 month prior to enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01999179


Contacts
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Contact: Lisa Baumann Kreuziger, MD, MS 414-937-6826 lisa.baumannkreuziger@bcw.edu

Locations
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United States, Minnesota
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Principal Investigator: Mark Reding, MD         
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Tzu-Fei Wang, MD       Tzu-Fei.Wang@osumc.edu   
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Lisa Baumann Kreuziger, MD, MS    414-937-6826    lisa.baumannkreuziger@bcw.edu   
Principal Investigator: Baumann Kreuziger Lisa, MD, MS         
Sub-Investigator: Parameswaran Hari, MD         
Sponsors and Collaborators
Medical College of Wisconsin
Blood Center of Wisconsin
Ohio State University
Investigators
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Principal Investigator: Lisa M Baumann Kreuziger, MD, MS Medical College of Wisconsin

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Responsible Party: Lisa Baumann Kreuziger, Assistant Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01999179     History of Changes
Other Study ID Numbers: PRO21429
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018

Keywords provided by Lisa Baumann Kreuziger, Medical College of Wisconsin:
catheter related thrombosis
upper extremity deep venous thrombosis
central venous catheters
cancer
Catheters

Additional relevant MeSH terms:
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Venous Insufficiency
Antithrombins
Thrombosis
Recurrence
Venous Thrombosis
Postthrombotic Syndrome
Postphlebitic Syndrome
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Phlebitis
Peripheral Vascular Diseases
Heparin
Calcium heparin
Rivaroxaban
Dabigatran
Apixaban
Edoxaban
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors