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Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients (DETECT)

Primary Purpose

Deep Vein Thrombosis, Pulmonary Embolism

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Proximal lower limb ultrasound
Sponsored by
King Abdullah International Medical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Deep Vein Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • Patient in the ICU for more than 2 calendar days
  • Patients with DVT or PE diagnosed within the last year
  • Patients receiving chronic systemic anticoagulation
  • Patients who have received up to the time of ICU admission or are receiving therapeutic dose of anticoagulation with UFH or LMWH or other anticoagulants

  • Inability or contraindication to obtain adequate ultrasound on the lower extremities

    • Burns in the lower extremities, lacerations, active skin infection, & ischemic limb in the legs, large dressings or in the thighs that prevent adequate ultrasounds
    • Acute ischemia in the lower extremities
    • Amputated foot or leg on one or two sides
    • Compartment Syndrome
    • Severe peripheral arterial disease
    • Vein ligation, gangrene, recent vein grafts, and draining incisions
    • Evidence of bone fracture in lower extremities
  • Patients with Inferior Vena Cava (IVC) Filter
  • Known or suspected pregnancy
  • Limitation of life support, life expectancy <7 days or palliative care
  • Previously enrolled in DETECT trial within the last 180 days
  • Enrolled in another trial for which co-enrolment is not approved

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Ultrasound Group

    Control Group

    Arm Description

    Patients will be receiving twice weekly proximal lower limb ultrasound

    Proximal lower limb ultrasound will be performed as per the treating team discretion

    Outcomes

    Primary Outcome Measures

    90-day mortality
    Mortality 90 days post randomization

    Secondary Outcome Measures

    Proximal DVT
    Incident proximal leg DVT, defined as detected 3 or more days post-randomization and up to ICU discharge
    Secondary outcomes related to proximal lower-extremity DVT
    Unilateral/bilateral proximal Lower-extremity DVT including central-venous-catheter- and non-central-venous-catheter-related incident proximal lower-extremity DVT defined as detected 3 or more days post-randomization and up to ICU discharge
    Distal DVT and all lower limb DVTS
    Incidence of distal DVT
    Pulmonary Embolism
    Pulmonary embolism defined as detected 3 or more days post-randomization and up to ICU discharge

    Full Information

    First Posted
    October 26, 2021
    Last Updated
    March 21, 2023
    Sponsor
    King Abdullah International Medical Research Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05112705
    Brief Title
    Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients
    Acronym
    DETECT
    Official Title
    Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients (DETECT) Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    January 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    King Abdullah International Medical Research Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    There is no randomized controlled trial examining surveillance ultrasonography for lower limb DVT in high-risk medical-surgical ICU patients compared to a clinician-directed approach. The DETECT randomized controlled trial addresses the question of whether surveillance ultrasound in critically ill patients by facilitating DVT detection reduces the incidence of PE and lowers all cause 90-day mortality. The primary outcome is 90-day all-cause mortality.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Deep Vein Thrombosis, Pulmonary Embolism

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1800 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ultrasound Group
    Arm Type
    Active Comparator
    Arm Description
    Patients will be receiving twice weekly proximal lower limb ultrasound
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Proximal lower limb ultrasound will be performed as per the treating team discretion
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Proximal lower limb ultrasound
    Intervention Description
    Twice weekly proximal lower limb ultrasound
    Primary Outcome Measure Information:
    Title
    90-day mortality
    Description
    Mortality 90 days post randomization
    Time Frame
    90 days
    Secondary Outcome Measure Information:
    Title
    Proximal DVT
    Description
    Incident proximal leg DVT, defined as detected 3 or more days post-randomization and up to ICU discharge
    Time Frame
    ICU discharge or day 28 post randomization
    Title
    Secondary outcomes related to proximal lower-extremity DVT
    Description
    Unilateral/bilateral proximal Lower-extremity DVT including central-venous-catheter- and non-central-venous-catheter-related incident proximal lower-extremity DVT defined as detected 3 or more days post-randomization and up to ICU discharge
    Time Frame
    ICU discharge or day 28 post randomization
    Title
    Distal DVT and all lower limb DVTS
    Description
    Incidence of distal DVT
    Time Frame
    ICU discharge or day 28 post randomization
    Title
    Pulmonary Embolism
    Description
    Pulmonary embolism defined as detected 3 or more days post-randomization and up to ICU discharge
    Time Frame
    ICU discharge or day 28 post randomization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Patient in the ICU for more than 2 calendar days Patients with DVT or PE diagnosed within the last year Patients receiving chronic systemic anticoagulation Patients who have received up to the time of ICU admission or are receiving therapeutic dose of anticoagulation with UFH or LMWH or other anticoagulants Inability or contraindication to obtain adequate ultrasound on the lower extremities Burns in the lower extremities, lacerations, active skin infection, & ischemic limb in the legs, large dressings or in the thighs that prevent adequate ultrasounds Acute ischemia in the lower extremities Amputated foot or leg on one or two sides Compartment Syndrome Severe peripheral arterial disease Vein ligation, gangrene, recent vein grafts, and draining incisions Evidence of bone fracture in lower extremities Patients with Inferior Vena Cava (IVC) Filter Known or suspected pregnancy Limitation of life support, life expectancy <7 days or palliative care Previously enrolled in DETECT trial within the last 180 days Enrolled in another trial for which co-enrolment is not approved
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yaseen Arabi
    Phone
    +966118011111
    Email
    yaseenarabi@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients

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