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Device

Etomidate for Stroke (SISCO Trial)

N/A
Waitlist Available
Led By Aimee Aysenne, M.D.
Research Sponsored by Life Recovery Systems
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hospital discharge or 5-7 days post-treatment (whichever comes first) and 90 +/- 10 days post stroke
Awards & highlights

Summary

This trial will test whether using a device to cool the body to 32-34°C can help improve recovery in stroke patients, compared to conventional care.

Eligible Conditions
  • Stroke
  • Brain Ischemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~hospital discharge or 5-7 days post-treatment (whichever comes first) and 90 +/- 10 days post-stroke
This trial's timeline: 3 weeks for screening, Varies for treatment, and hospital discharge or 5-7 days post-treatment (whichever comes first) and 90 +/- 10 days post-stroke for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in neurological outcome as indicated by NIHSS
Change in neurological status as indicated by MRS
Feasibility of cooling as indicated by percentage of patients cooled to target within 1 hour of start of cooling
+3 more
Secondary outcome measures
Mortality
Quality of Life as indicated by Neuro-QOL score
Rates of procedure and device related SAEs

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ThermoSuit Cooling InductionExperimental Treatment6 Interventions
Induction of therapeutic hypothermia (32-34 degrees C) using the LRS ThermoSuit System. Prior to initiating hypothermia, Magnesium Sulfate will be administered intravenously to control shivering and tPA administered intravenously (if indicated). Induction doses of propofol or etomidate will be used to aid in the suppression of patient discomfort. Neurothrombectomy will be performed if indicated.
Group II: Historical ControlActive Control1 Intervention
Historical patients treated for ischemic stroke using conventional medical treatments, but without induced hypothermia.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnesium Sulfate
2011
Completed Phase 4
~5160
tPA
2020
Completed Phase 4
~100
Etomidate
2013
Completed Phase 4
~6950
Neurothrombectomy
2021
N/A
~430
Propofol
2017
Completed Phase 4
~1530

Find a Location

Who is running the clinical trial?

Geisinger ClinicOTHER
149 Previous Clinical Trials
1,883,479 Total Patients Enrolled
1 Trials studying Stroke
2,386 Patients Enrolled for Stroke
Tulane University School of MedicineOTHER
33 Previous Clinical Trials
17,670 Total Patients Enrolled
Life Recovery SystemsLead Sponsor
4 Previous Clinical Trials
57 Total Patients Enrolled
~2 spots leftby Jul 2025
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