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Intermittent Pneumatic Compression of the Upper Extremity for Post-Operative VTE Prophylaxis

Primary Purpose

Venous Thromboses

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intermittent Pneumatic Compression Device (FDA approved)
Sponsored by
Baltimore VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

• Males aged > 18 years who could provide informed consent

Exclusion Criteria:

  • Patients on coumadin or post-operative therapeutic heparin
  • Known history of venous thromboembolism (VTE)
  • Known history of hematological disorders
  • Diagnosed malignancy requiring or undergoing treatment
  • Presence of upper extremity arterio-venous access for hemodialysis
  • Females were excluded to eliminate the confounding thrombogenic effect of estrogen.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    Upper Extremity Compression Device

    Control

    Arm Description

    Patients randomized to have pneumatic compression device placed on upper extremity following surgery

    Patients randomized to have pneumatic compression device placed on lower extremity following surgery

    Outcomes

    Primary Outcome Measures

    venous thromboembolic event following surgery
    venous thrombosis (VT) or pulmonary embolism (PE): number of screening lower extremity venous duplex ultrasound studies showing VT and any CT scans showing PE in symptomatic patients

    Secondary Outcome Measures

    Full Information

    First Posted
    April 7, 2020
    Last Updated
    April 9, 2020
    Sponsor
    Baltimore VA Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04341272
    Brief Title
    Intermittent Pneumatic Compression of the Upper Extremity for Post-Operative VTE Prophylaxis
    Official Title
    Intermittent Pneumatic Compression of the Upper Extremity for Post-Operative VTE Prophylaxis: A Pilot Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2014 (Actual)
    Primary Completion Date
    April 5, 2017 (Actual)
    Study Completion Date
    April 5, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Baltimore VA Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Venous thromboembolism (VTE) is an important cause of morbidity and mortality following surgery.A combination of chemical and mechanical prophylaxis using lower extremity compression devices (CD) is recommended in patients who are considered at 'moderate risk' (Caprini score 2 - 4) or 'high risk' (Caprini score > 4) of developing VTE. The aim of this study was to determine whether upper extremity (UE) CD are as effective as lower extremity (LE) CD in preventing VTE following surgery. A total of 106 patients were recruited.
    Detailed Description
    Hospitals throughout the United States currently utilize mechanical compression devices on patients' limbs for prevention of blood clots, in addition to blood thinning medication - heparin. The compression devices act by affect blood clotting mechanism and there is evidence from previous research studies that blood is less likely to develop clots when these compression devices are placed on the arms or legs. The use of compression devices on arms and legs is within standard of care, but use on legs tends to be more common. Research studies have shown that use of compression devices in combination with heparin is more effective in preventing blood clots than either one alone. Not many clinicians remember the option of placing compression devices on arms, and patients who do not get compression devices placed on their legs following surgery, often get only medication (heparin) with no compression device placed at all. This study will compare the effectiveness of compression devices used on patients' arms with those used on patients' legs, at preventing blood clots. Non-invasive ultrasound studies will be used after surgery to check for blood clots in the legs.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Venous Thromboses

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    106 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Upper Extremity Compression Device
    Arm Type
    Active Comparator
    Arm Description
    Patients randomized to have pneumatic compression device placed on upper extremity following surgery
    Arm Title
    Control
    Arm Type
    Other
    Arm Description
    Patients randomized to have pneumatic compression device placed on lower extremity following surgery
    Intervention Type
    Device
    Intervention Name(s)
    Intermittent Pneumatic Compression Device (FDA approved)
    Intervention Description
    Compression Device placed on either upper or lower extremity for DVT prophylaxis following surgery
    Primary Outcome Measure Information:
    Title
    venous thromboembolic event following surgery
    Description
    venous thrombosis (VT) or pulmonary embolism (PE): number of screening lower extremity venous duplex ultrasound studies showing VT and any CT scans showing PE in symptomatic patients
    Time Frame
    within 45 days following surgery

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: • Males aged > 18 years who could provide informed consent Exclusion Criteria: Patients on coumadin or post-operative therapeutic heparin Known history of venous thromboembolism (VTE) Known history of hematological disorders Diagnosed malignancy requiring or undergoing treatment Presence of upper extremity arterio-venous access for hemodialysis Females were excluded to eliminate the confounding thrombogenic effect of estrogen.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Preeti R John, MD, MPH, FACS
    Organizational Affiliation
    Baltimore VA Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://www.journalacs.org/article/S1072-7515(16)31034-1/abstract
    Description
    Priliminary data published in Journal of American College of Surgeons abstract

    Learn more about this trial

    Intermittent Pneumatic Compression of the Upper Extremity for Post-Operative VTE Prophylaxis

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