Helping Stroke Patients With ThermoSuit Cooling

Summary

The aim of this study is to assess the feasibility of using the Life Recovery Systems ThermoSuit Device to induce therapeutic hypothermia (32-34°C) in victims of ischemic stroke. This feasibility clinical study will enroll a total of 30 patients with acute ischemic stroke at four clinical centers. Subjects will receive hypothermia plus conventional therapy (such as IV-tPA and/or neurothrombectomy therapies if indicated). Endpoints will include feasibility of cooling, adverse events, and neurological recovery in comparison with matched historical controls.

Conditions

• Stroke
• Brain Ischemia

Interventions

DEVICE

ThermoSuit Cooling Induction

Rapid induction of therapeutic hypothermia (32-34 degrees C) using the Life Recovery Systems ThermoSuit System

DRUG

Magnesium Sulfate

Magnesium sulfate will be administered intravenously as needed to control shivering

DRUG

tPA

tPA will be administered intravenously if indicated

DRUG

Propofol

Induction doses of propofol or etomidate will be used to aid in the suppression of patient discomfort

DRUG

Etomidate

Induction doses of propofol or etomidate will be used to aid in the suppression of patient discomfort

PROCEDURE

Neurothrombectomy

If indicated, neurothrombectomy will be performed using an FDA-cleared device within the FDA-cleared treatment window.

Sponsors & Collaborators

• Tulane University School of Medicine

  collaborator OTHER

• Geisinger Clinic

  collaborator OTHER

• Life Recovery Systems

  lead OTHER

Principal Investigators

• Aimee Aysenne, M.D. · Tulane University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-25

Primary Completion

2023-06-01

Completion

2023-06-02

FDA Device

Yes

Countries

• United States

Study Locations