Earlier Mobilization Post Acute Thrombolysis (EMPATHY-I)

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.

Study Overview

• Status: Withdrawn
• Conditions: Stroke; Stroke, Ischemic; Stroke, Acute
• Intervention / Treatment: Behavioral: Mobilization

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Brian Silver, MD; Phone Number: 508-334-2527; Email: brian.silver@umassmemorial.org
• Study Contact Backup: Name: Meaghan Demers-Peel, BS; Phone Number: 774-455-6568; Email: meaghan.demers-peel@umassmed.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 12-Hour Bed Rest; Subjects will be mobilized 12 hours after receiving IV thrombolysis therapy per usual care	Behavioral: Mobilization; Any movement out of bed
Active Comparator: 24-Hour Bed Rest; Subjects will be mobilized 24 hours after receiving IV thrombolysis therapy per usual care	Behavioral: Mobilization; Any movement out of bed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	90 days post bed rest

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Duration of hospitalization stay, average 5 days
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.	Duration of hospitalization stay, average 5 days
Readmission	Determine whether rates of readmission are at least similar in the two arms.	90 days post bed rest
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.	Duration of hospitalization stay, average 5 days
Length of Stay	Determine whether hospital length of stay are at least similar in the two arms. This will ve measured in days.	Duration of hospitalization stay, average 5 days

Collaborators and Investigators

• Sponsor: Brian Silver
• Investigators: Principal Investigator: Brian Silver, MD, UMass Medical School

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Recovery; Ischemia; Brain Diseases; Mobilization; Cerebrovascular Disorders; Thrombolysis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: H00018238

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No