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Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients

Primary Purpose

Venous Thromboembolism

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Fondaparinux
Enoxaparin
Sponsored by
Eastern Virginia Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring Venous Thromboembolism Prophylaxis, VTE prophylaxis

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Ability or legally authorized representative (LAR) to provide informed consent
  2. Adult who has not had surgery within 10 days, admitted to the Sentara Norfolk General Hospital ICU Medical Teaching Services for any reason.

Exclusion Criteria:

  1. Active or suspected bleeding
  2. Platelet count less than 100,000 per microliter (mm3) of blood
  3. Thrombolytic or anticoagulant treatment (including any doses of prophylactic UFH, LMWH or fondaparinux) during the current hospitalization
  4. Initial estimated CLcr < 30 ml/min as determined by the Cockcroft-Gault equation
  5. Initial labs indicative or suggestive of rapidly rising serum Creatinine (>1 mg/dL/day)
  6. Pregnancy (for medicolegal considerations)
  7. Patients with or expecting to require an epidural catheter
  8. Patients who are expected to have an immediate (within 24h) need for surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Fondaparinux

    2

    Arm Description

    Fondaparinux treatment - one standard of care option

    Enoxaparin

    Outcomes

    Primary Outcome Measures

    Bleeding events

    Secondary Outcome Measures

    Development of thrombocytopenia

    Full Information

    First Posted
    June 27, 2007
    Last Updated
    April 7, 2022
    Sponsor
    Eastern Virginia Medical School
    Collaborators
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00493896
    Brief Title
    Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients
    Official Title
    Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients: An Investigator Initiated Protocol
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Terminated
    Why Stopped
    low enrollment
    Study Start Date
    July 2007 (undefined)
    Primary Completion Date
    April 2010 (Actual)
    Study Completion Date
    April 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Eastern Virginia Medical School
    Collaborators
    GlaxoSmithKline

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population.
    Detailed Description
    This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population. We expect the null hypothesis to be proven true. One hundred subjects will be enrolled in this prospective, randomized, double-blind (concealed allocation) pilot study of consecutive medical ICU patients to one of two pharmacologic VTE prophylaxix treatment arms. (1) Primary endpoints include hemoglobin, hematocrit, & platelet counts. blood product utilization, bleeding complications (any), Steady State Functional Factor Xa activity (for post hoc analysis), non-study pharmacologic VTE prophylaxis (when estimated CLcr < 30ml/min), and days not treated with study drug or treated with alternative agent Secondary/ Additional Data to be collected include patient demographics, primary & secondary diagnoses, central venous access, and sequential compression device utilization.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Venous Thromboembolism
    Keywords
    Venous Thromboembolism Prophylaxis, VTE prophylaxis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    27 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fondaparinux
    Arm Type
    Experimental
    Arm Description
    Fondaparinux treatment - one standard of care option
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Enoxaparin
    Intervention Type
    Drug
    Intervention Name(s)
    Fondaparinux
    Other Intervention Name(s)
    Arixtra
    Intervention Description
    The dose for Arixtra is 2.5 mg once daily, subcutaneously.
    Intervention Type
    Drug
    Intervention Name(s)
    Enoxaparin
    Other Intervention Name(s)
    Lovenox
    Intervention Description
    The dose for Lovenox is 40 mg once daily, subcutaneously.
    Primary Outcome Measure Information:
    Title
    Bleeding events
    Time Frame
    inpatient hospitalization
    Secondary Outcome Measure Information:
    Title
    Development of thrombocytopenia
    Time Frame
    inpatient hospitalization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ability or legally authorized representative (LAR) to provide informed consent Adult who has not had surgery within 10 days, admitted to the Sentara Norfolk General Hospital ICU Medical Teaching Services for any reason. Exclusion Criteria: Active or suspected bleeding Platelet count less than 100,000 per microliter (mm3) of blood Thrombolytic or anticoagulant treatment (including any doses of prophylactic UFH, LMWH or fondaparinux) during the current hospitalization Initial estimated CLcr < 30 ml/min as determined by the Cockcroft-Gault equation Initial labs indicative or suggestive of rapidly rising serum Creatinine (>1 mg/dL/day) Pregnancy (for medicolegal considerations) Patients with or expecting to require an epidural catheter Patients who are expected to have an immediate (within 24h) need for surgery
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charles W Callender, MD
    Organizational Affiliation
    Eastern VA Medical School, Norfolk, VA
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients

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