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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

SISCO Trial 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

SISCO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ hospital discharge or 5-7 days post-treatment (whichever comes first) and 90 +/- 10 days post-stroke

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

SISCO 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

~5870

Neurothrombectomy

2018

N/A

~230

Propofol

2017

Completed Phase 4

~1530

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Geisinger ClinicOTHER

148 Previous Clinical Trials

1,886,079 Total Patients Enrolled

1 Trials studying Stroke

2,386 Patients Enrolled for Stroke

Tulane University School of MedicineOTHER

33 Previous Clinical Trials

17,470 Total Patients Enrolled

Life Recovery SystemsLead Sponsor

4 Previous Clinical Trials

57 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there openings for volunteers in this experiment?

"Clinicaltrials.gov demonstrates that this trial is recruiting patients, with the initial posting on January 25th 2017 and the latest update being July 12th 2022."

Answered by AI

What medical conditions are usually addressed with Etomidate?

"Hypomagnesemia is best treated with Etomidate, which additionally shows efficacy in the prevention of hypomagnesemia and sedation for monitored anesthesia care therapy or convulsions."

Answered by AI

In what other research has Etomidate been featured?

"Etomidate was first researched at Keck Medical Center of USC in the year 2004 and has since been examined across 841 completed trials. Presently, 120 studies are active with a large concentration based out of Danville, Louisiana."

Answered by AI

To what extent has participation been recorded for this examination?

"Affirmative. Clinicaltrials.gov reveals that sign-up for this medical study, which was posted on the 25th of January 2017, is currently open. 30 patients must be enrolled from 3 separate sites."

Answered by AI

Recent research and studies

StrokeJournal

2018 Guidelines for the Early Management of Patients with Acute Ischemic Stroke: A Guideline for Healthcare Professionals from the American Heart Association/american Stroke Association

Powers, William J., Alejandro A. Rabinstein, Teri Ackerson, Opeolu M. Adeoye, Nicholas C. Bambakidis, Kyra Becker, José Biller, et al.. 2018. “2018 Guidelines for the Early Management of Patients with Acute Ischemic Stroke: A Guideline for Healthcare Professionals from the American Heart Association/american Stroke Association”. Stroke. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/str.0000000000000158.

clinicaltrials.govStudy

Helping Stroke Patients With ThermoSuit Cooling

2017. "Helping Stroke Patients With ThermoSuit Cooling". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02453373.