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

Sponsor
Medical College of Wisconsin (Other)
Overall Status
Completed
CT.gov ID
NCT01999179
Collaborator
Versiti (Other), Ohio State University (Other)
27
3
1
94.8
9
0.1

Study Details

Study Description

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
  • Drug: Heparin, Low-Molecular-Weight, or direct oral anticoagulants
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
N/A
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 :
Jun 1, 2014
Actual Primary Completion Date :
Apr 2, 2019
Actual Study Completion Date :
Apr 26, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: 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
  • Outcome Measures

    Primary Outcome Measures

    1. PTS Assessment Completion [1 year]

      Percentage of participants who completed post-thrombotic syndrome assessments

    Secondary Outcome Measures

    1. Biomarker Sample Collection [1 year]

      Number of participants that completed sample collection for biomarker analysis to predict recurrent venous thrombosis

    Other Outcome Measures

    1. Number of Participants With Post-thrombotic Syndrome [6 months after catheter removal]

      The number of participants with post-thrombotic syndrome 6 months after catheter removal in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation

    2. Number of Participants With Recurrent Thrombosis [6 months after catheter removal]

      Number of participants with recurrent thrombosis in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation

    3. Number of Participants With Major Bleeding [6 months after catheter removal]

      Number of participants with major bleeding in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Minnesota Minneapolis Minnesota United States 55455
    2 The Ohio State University Columbus Ohio United States 43210
    3 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Medical College of Wisconsin
    • Versiti
    • Ohio State University

    Investigators

    • Principal Investigator: Lisa M Baumann Kreuziger, MD, MS, Medical College of Wisconsin

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Lisa Baumann Kreuziger, Assistant Professor, Medical College of Wisconsin
    ClinicalTrials.gov Identifier:
    NCT01999179
    Other Study ID Numbers:
    • PRO21429
    First Posted:
    Dec 3, 2013
    Last Update Posted:
    May 18, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Lisa Baumann Kreuziger, Assistant Professor, Medical College of Wisconsin
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Low-molecular-weight Heparin or Direct Oral Anticoagulant
    Arm/Group Description 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. 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
    Period Title: Overall Study
    STARTED 27
    COMPLETED 20
    NOT COMPLETED 7

    Baseline Characteristics

    Arm/Group Title Low-molecular-weight Heparin or Direct Oral Anticoagulant
    Arm/Group Description 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. 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
    Overall Participants 27
    Age (years) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [years]
    59
    Sex: Female, Male (Count of Participants)
    Female
    11
    40.7%
    Male
    16
    59.3%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    3.7%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    5
    18.5%
    White
    21
    77.8%
    More than one race
    0
    0%
    Unknown or Not Reported
    0
    0%
    Region of Enrollment (Count of Participants)
    United States
    27
    100%

    Outcome Measures

    1. Primary Outcome
    Title PTS Assessment Completion
    Description Percentage of participants who completed post-thrombotic syndrome assessments
    Time Frame 1 year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Low-molecular-weight Heparin or Direct Oral Anticoagulant
    Arm/Group Description 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. 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
    Measure Participants 27
    Count of Participants [Participants]
    17
    63%
    2. Secondary Outcome
    Title Biomarker Sample Collection
    Description Number of participants that completed sample collection for biomarker analysis to predict recurrent venous thrombosis
    Time Frame 1 year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Low-molecular-weight Heparin or Direct Oral Anticoagulant
    Arm/Group Description 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. 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
    Measure Participants 12
    Number [participants]
    7
    25.9%
    3. Other Pre-specified Outcome
    Title Number of Participants With Post-thrombotic Syndrome
    Description The number of participants with post-thrombotic syndrome 6 months after catheter removal in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation
    Time Frame 6 months after catheter removal

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Low-molecular-weight Heparin or Direct Oral Anticoagulant
    Arm/Group Description 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. 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
    Measure Participants 20
    Count of Participants [Participants]
    0
    0%
    4. Other Pre-specified Outcome
    Title Number of Participants With Recurrent Thrombosis
    Description Number of participants with recurrent thrombosis in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation
    Time Frame 6 months after catheter removal

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Low-molecular-weight Heparin or Direct Oral Anticoagulant
    Arm/Group Description 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. 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
    Measure Participants 20
    Count of Participants [Participants]
    0
    0%
    5. Other Pre-specified Outcome
    Title Number of Participants With Major Bleeding
    Description Number of participants with major bleeding in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation
    Time Frame 6 months after catheter removal

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Low-molecular-weight Heparin or Direct Oral Anticoagulant
    Arm/Group Description 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. 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
    Measure Participants 20
    Count of Participants [Participants]
    1
    3.7%

    Adverse Events

    Time Frame 6 months
    Adverse Event Reporting Description
    Arm/Group Title Low-molecular-weight Heparin or Direct Oral Anticoagulant
    Arm/Group Description 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. 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
    All Cause Mortality
    Low-molecular-weight Heparin or Direct Oral Anticoagulant
    Affected / at Risk (%) # Events
    Total 0/27 (0%)
    Serious Adverse Events
    Low-molecular-weight Heparin or Direct Oral Anticoagulant
    Affected / at Risk (%) # Events
    Total 1/27 (3.7%)
    Musculoskeletal and connective tissue disorders
    Hematoma 1/27 (3.7%)
    Other (Not Including Serious) Adverse Events
    Low-molecular-weight Heparin or Direct Oral Anticoagulant
    Affected / at Risk (%) # Events
    Total 2/27 (7.4%)
    Blood and lymphatic system disorders
    Bleeding 2/27 (7.4%)
    General disorders
    Fall 2/27 (7.4%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr Lisa Baumann Kreuziger
    Organization Versiti
    Phone 414-937-6826
    Email lisakreuziger@versiti.org
    Responsible Party:
    Lisa Baumann Kreuziger, Assistant Professor, Medical College of Wisconsin
    ClinicalTrials.gov Identifier:
    NCT01999179
    Other Study ID Numbers:
    • PRO21429
    First Posted:
    Dec 3, 2013
    Last Update Posted:
    May 18, 2022
    Last Verified:
    Apr 1, 2022