Back to resultsEarlier Mobilization Post Acute Thrombolysis (EMPATHY-I)
Primary Purpose
Stroke, Stroke, Acute, Stroke, Ischemic
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Mobilization
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Mobilization, Thrombolysis, Ischemia, Cerebrovascular Disorders, Brain Diseases, Recovery
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older
- Received intravenous tPA for a clinical diagnosis of acute ischemic stroke
- Patient and/or Legally Authorized Representative provide consent
Exclusion Criteria:
- 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
- Treatment includes or anticipated to include thrombectomy
- 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 receiving IV thrombolysis therapy per usual care
Subjects will be mobilized 24 hours after receiving IV thrombolysis therapy per usual care
Outcomes
Primary Outcome Measures
90 day mRS
Proportion of patients with a modified Rankin Scale score (min 0, max 5 with 0 being 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 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 hospital length of stay are at least similar in the two arms. This will ve measured in days.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04153942
Brief Title
Earlier Mobilization Post Acute Thrombolysis
Acronym
EMPATHY-I
Official Title
Earlier Mobilization Post Acute Thrombolysis
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 IV thrombolysis therapy (i.e. tPA) 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, Thrombolysis, 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
694 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
12-Hour Bed Rest
Arm Type
Experimental
Arm Description
Subjects will be mobilized 12 hours after receiving IV thrombolysis therapy per usual care
Arm Title
24-Hour Bed Rest
Arm Type
Active Comparator
Arm Description
Subjects will be mobilized 24 hours after receiving IV thrombolysis therapy per usual care
Intervention Type
Behavioral
Intervention Name(s)
Mobilization
Intervention Description
Any movement out of bed
Primary Outcome Measure Information:
Title
90 day mRS
Description
Proportion of patients with a modified Rankin Scale score (min 0, max 5 with 0 being 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 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 hospital length of stay are at least similar in the two arms. This will ve 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 intravenous tPA for a clinical diagnosis of acute ischemic stroke
Patient and/or Legally Authorized Representative provide consent
Exclusion Criteria:
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
Treatment includes or anticipated to include thrombectomy
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
Learn more about this trial
Earlier Mobilization Post Acute Thrombolysis
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