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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

Tracking Information
First Submitted Date  ICMJE November 25, 2013
First Posted Date  ICMJE December 3, 2013
Last Update Posted Date August 28, 2018
Study Start Date  ICMJE June 2014
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2015)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
Feasibility [ Time Frame: 1 year ]
Recruitment of 56 patients in 1 year and 80% completion of post-thrombotic syndrome assessments by enrolled patients
Change History Complete list of historical versions of study NCT01999179 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2015)
Number of plasma samples obtained for biomarker analysis to predict recurrent venous thrombosis [ Time Frame: 1 year ]
Obtaining 80% of samples from enrolled patients
Original Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
Feasibility [ Time Frame: 1 year ]
Obtaining 80% of samples from enrolled patients
Current Other Pre-specified Outcome Measures
 (submitted: October 22, 2015)
  • 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
  • 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
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: December 2, 2013)
  • Incidence of post-thrombotic syndrome [ Time Frame: 6 months after catheter removal ]
  • Incidence of recurrent thrombosis [ Time Frame: 6 months after catheter removal ]
  • Incidence of major and clinically relevant non-major bleeding [ Time Frame: 6 months after catheter removal ]
 
Descriptive Information
Brief Title  ICMJE Post-thrombotic Syndrome & Predictors of Recurrence in Catheter-related Thrombosis
Official Title  ICMJE Pilot Study of Post-thrombotic Syndrome & Predictors of Recurrence in Cancer Patients With Catheter-related Thrombosis
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Venous Thrombosis
  • Neoplasms
Intervention  ICMJE 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
Study Arms  ICMJE 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.

Intervention: Drug: Heparin, Low-Molecular-Weight, or direct oral anticoagulants
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  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 2, 2013)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lisa Baumann Kreuziger, MD, MS 414-937-6826 lisa.baumannkreuziger@bcw.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01999179
Other Study ID Numbers  ICMJE PRO21429
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lisa Baumann Kreuziger, Medical College of Wisconsin
Study Sponsor  ICMJE Medical College of Wisconsin
Collaborators  ICMJE
  • Blood Center of Wisconsin
  • Ohio State University
Investigators  ICMJE
Principal Investigator: Lisa M Baumann Kreuziger, MD, MS Medical College of Wisconsin
PRS Account Medical College of Wisconsin
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP