Earlier Mobilization Post Acute Thrombectomy

Stroke Clinical Trial

— EMPATHY-II  

Official title:

Earlier Mobilization Post Acute Thrombectomy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04153955
• Other study ID #: H00018239
• Status: Withdrawn
• Phase: Phase 3
• Start date: August 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Acute
• Stroke, Ischemic

Intervention

Behavioral:
• Mobilization
Any movement out of bed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brian Silver

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	90 days post bed rest
Secondary	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
Secondary	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.	Duration of hospitalization stay, average 5 days
Secondary	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
Secondary	Readmission	Determine whether rates of readmission are at least similar in the two arms.	90 days post bed rest
Secondary	Length of Stay	Determine whether length of hospital stay are at least similar in the two arms. This will be measured in days.	Duration of hospitalization stay, average 5 days