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Earlier Mobilization Post Acute Thrombectomy (EMPATHY-II)

Primary Purpose

Stroke, Stroke, Acute, Stroke, Ischemic

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Mobilization
Sponsored by
Brian Silver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Mobilization, Thrombectomy, Ischemia, Cerebrovascular Disorders, Brain Diseases, Recovery

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 years or older
  • Received thrombectomy (may have also received intravenous tPA) for a diagnosis of acute ischemic stroke
  • TICI 2b/2c/3 score following thromectomy
  • Patient and/or Legally Authorized Representative provide consent

Exclusion Criteria:

  • TICI 0/1/2a score following thrombectomy
  • Venous thromboembolism present at symptom onset
  • Pneumonia present at symptom onset
  • STEMI at symptom onset
  • Positive troponins at symptom onset according to local values
  • Bone fracture at symptom onset
  • Intubation anticipated or occurred
  • Symptomatic intracranial hemorrhage (defined as increase in NIHSS by 4 points or more accompanied by PH2 hemorrhage on imaging) at the time of screening.
  • Pre-screening systolic blood pressure < 110 mmHg
  • Resting pulse oximetry < 92% (with or without supplemental oxygen)
  • Neurological worsening (defined as NIHSS increase of 4 points compared to initial score) prior to screening.
  • Baseline modified Rankin Scale score > 2
  • Known Pregnancy
  • Patient not anticipated to survive 3 months
  • Patient not anticipated to follow-up at 3 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    12-Hour Bed Rest

    24-Hour Bed Rest

    Arm Description

    Subjects will be mobilized 12 hours after undergoing thrombectomy per usual care

    Subjects will be mobilized 24 hours after undergoing thrombectomy per usual care

    Outcomes

    Primary Outcome Measures

    90 Day Modified Rankin Scale (mRS) score
    Proportion of patients with a modified Rankin Scale score (min 0, max 5 with 0 being the best outcome) of 0-2 at 90 days

    Secondary Outcome Measures

    Pneumonia
    Determine whether rates of pneumonia are at least similar in the two arms. Rates will be measured as percentages of the entire population at risk.
    Venous Thromboembolism
    Determine whether rates of Venous Thromboembolism (VTE) are at least similar in the two arms. Rates will be measured as percentages of the entire population at risk.
    Neurological Worsening
    Determine whether rates of neurological worsening are at least similar in the two arms. Rates will be measured as percentages of the entire population at risk.
    Readmission
    Determine whether rates of readmission are at least similar in the two arms.
    Length of Stay
    Determine whether length of hospital stay are at least similar in the two arms. This will be measured in days.

    Full Information

    First Posted
    October 21, 2019
    Last Updated
    May 10, 2023
    Sponsor
    Brian Silver
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04153955
    Brief Title
    Earlier Mobilization Post Acute Thrombectomy
    Acronym
    EMPATHY-II
    Official Title
    Earlier Mobilization Post Acute Thrombectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Brian Silver

    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
    This is a phase III trial trying to determine whether 12-hour bed rest following thrombectomy for ischemic stroke is non-inferior to 24-hour bed rest by measure of outcomes on the modified Rankin Scale (mRS) at 90 days post bed rest.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Stroke, Acute, Stroke, Ischemic
    Keywords
    Mobilization, Thrombectomy, Ischemia, Cerebrovascular Disorders, Brain Diseases, Recovery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    Assessors blind to the subject's treatment/arm will do the evaluations at 90 days
    Allocation
    Randomized
    Enrollment
    852 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    12-Hour Bed Rest
    Arm Type
    Experimental
    Arm Description
    Subjects will be mobilized 12 hours after undergoing thrombectomy per usual care
    Arm Title
    24-Hour Bed Rest
    Arm Type
    Active Comparator
    Arm Description
    Subjects will be mobilized 24 hours after undergoing thrombectomy per usual care
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mobilization
    Intervention Description
    Any movement out of bed
    Primary Outcome Measure Information:
    Title
    90 Day Modified Rankin Scale (mRS) score
    Description
    Proportion of patients with a modified Rankin Scale score (min 0, max 5 with 0 being the best outcome) of 0-2 at 90 days
    Time Frame
    90 days post bed rest
    Secondary Outcome Measure Information:
    Title
    Pneumonia
    Description
    Determine whether rates of pneumonia are at least similar in the two arms. Rates will be measured as percentages of the entire population at risk.
    Time Frame
    Duration of hospitalization stay, average 5 days
    Title
    Venous Thromboembolism
    Description
    Determine whether rates of Venous Thromboembolism (VTE) are at least similar in the two arms. Rates will be measured as percentages of the entire population at risk.
    Time Frame
    Duration of hospitalization stay, average 5 days
    Title
    Neurological Worsening
    Description
    Determine whether rates of neurological worsening are at least similar in the two arms. Rates will be measured as percentages of the entire population at risk.
    Time Frame
    Duration of hospitalization stay, average 5 days
    Title
    Readmission
    Description
    Determine whether rates of readmission are at least similar in the two arms.
    Time Frame
    90 days post bed rest
    Title
    Length of Stay
    Description
    Determine whether length of hospital stay are at least similar in the two arms. This will be measured in days.
    Time Frame
    Duration of hospitalization stay, average 5 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 years or older Received thrombectomy (may have also received intravenous tPA) for a diagnosis of acute ischemic stroke TICI 2b/2c/3 score following thromectomy Patient and/or Legally Authorized Representative provide consent Exclusion Criteria: TICI 0/1/2a score following thrombectomy Venous thromboembolism present at symptom onset Pneumonia present at symptom onset STEMI at symptom onset Positive troponins at symptom onset according to local values Bone fracture at symptom onset Intubation anticipated or occurred Symptomatic intracranial hemorrhage (defined as increase in NIHSS by 4 points or more accompanied by PH2 hemorrhage on imaging) at the time of screening. Pre-screening systolic blood pressure < 110 mmHg Resting pulse oximetry < 92% (with or without supplemental oxygen) Neurological worsening (defined as NIHSS increase of 4 points compared to initial score) prior to screening. Baseline modified Rankin Scale score > 2 Known Pregnancy Patient not anticipated to survive 3 months Patient not anticipated to follow-up at 3 months
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Brian Silver, MD
    Phone
    508-334-2527
    Email
    brian.silver@umassmemorial.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Meaghan Demers-Peel, BS
    Phone
    774-455-6568
    Email
    meaghan.demers-peel@umassmed.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brian Silver, MD
    Organizational Affiliation
    UMass Medical School
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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