Helping Stroke Patients With ThermoSuit Cooling

NCT02453373 | Terminated DMC FDA Device

• 1 other identifier: LRS-01-13-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (6)

• Feasibility of cooling as indicated by percentage of patients cooled to target within 1 hour of start of cooling

  Feasibility of rapidly cooling victims of ischemic stroke with the ThermoSuit System to 32-34°C.

  1 hour after start of cooling

• Neurological outcome as indicated by NIHSS

  NIH Stroke Scale at hospital discharge or day 5-7 post-treatment (whichever comes first)

  Hospital discharge or day 5-7 post-treatment (whichever comes first)

• Safety of the cooling treatment as indicated by rates of significant adverse events

  A comparison of significant adverse event rates between the treatment and historical control group.

  30 days

• Neurological outcome as indicated by MRS score

  Dichotomized modified Rankin score (mRS); an mRS score of less than or equal to 2 is to be considered a good outcome

  Hospital discharge or day 5-7 post-treatment (whichever comes first)

• Change in neurological outcome as indicated by NIHSS

  Change in NIHSS from that measured at hospital discharge or 5-7 days post-treatment (whichever comes first) to that measured at 90 +/- 10 days post-stroke

  Hospital discharge or 5-7 days post-treatment (whichever comes first) and 90 +/- 10 days post-stroke

• Change in neurological status as indicated by MRS

  Change in dichotomized modified Rankin scale from that measured at hospital discharge or 5-7 days post-treatment (whichever comes first) to that measured at 90 +/- 10 days post-stroke

  Hospital discharge or 5-7 days post-treatment (whichever comes first) and 90 +/- 10 days post-stroke

Secondary Outcomes (3)

• Mortality

  90 days

• Quality of Life as indicated by Neuro-QOL score

  Hospital discharge or 5-7 days post-treatment (whichever comes first) and 90 +/- 10 days post stroke

• Rates of procedure and device related SAEs

  0 to 90 days

Study Arms (2)

ThermoSuit Cooling Induction

EXPERIMENTAL

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.

Device: ThermoSuit Cooling Induction; Drug: Magnesium Sulfate; Drug: tPA; Drug: Propofol; Drug: Etomidate; Procedure: Neurothrombectomy

Historical Control

NO INTERVENTION

Historical patients treated for ischemic stroke using conventional medical treatments, but without induced hypothermia.

Interventions

ThermoSuit Cooling Induction DEVICE

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

Also known as: LRS ThermoSuit

ThermoSuit Cooling Induction

Magnesium Sulfate DRUG

Magnesium sulfate will be administered intravenously as needed to control shivering

Also known as: Epsom salt, Magnesium sulphate

ThermoSuit Cooling Induction

tPA DRUG

tPA will be administered intravenously if indicated

Also known as: Tissue plasminogen activator

ThermoSuit Cooling Induction

Propofol DRUG

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

Also known as: Diprivan

ThermoSuit Cooling Induction

Etomidate DRUG

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

Also known as: Amidate

ThermoSuit Cooling Induction

Neurothrombectomy PROCEDURE

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

Also known as: Endovascular Thrombectomy

ThermoSuit Cooling Induction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischemic cortical stroke with NIHSS \> \_5\_;
• Treatment must be initiated within 8 hours from known time of symptom onset or, for eligible patients under the current AHA Guidelines, within the extended time window for mechanical thrombectomy of up to 24 hours.
• Patient dimension criteria: Height: 147-190 cm (58 - 75 in) Width: ≤66 cm (26 in) (elbow to elbow).

You may not qualify if:

• Sepsis (bacteremia and clinical syndrome within 72 h);
• Known preexisting coagulopathy, (INR \> 1.3, PTT \>1.5 x control), active bleeding of unknown cause, immune compromised state, thrombocytopenia (platelet count \< 160,000/mm), and history of cold agglutinin disease;
• Hemodynamically significant cardiac dysrhythmias (eg. QTc interval \>450 msec, bradycardia (heart rate less than 50), Mobitz Type II second degree AV block (or higher AV block), and severe ventricular dysrhythmias (sustained VT or VF) ) which cause significant hypotension (SBP ≤ 120 mmHg requiring more than two pressor medications);
• Preexistent illness with life expectancy \<6 months;
• Pregnancy;
• Rapidly improving symptoms;
• Melena, or gross hematuria;
• Sickle cell disease;
• Temperature \< 35°C on admission to Emergency Department;
• Recent (\< 1 week) incisions;
• Any intracerebral hemorrhage;
• A history of a brain vascular lesion (e.G. aneurism or arteriovenous malformation);
• A history of brain disease or damage (e.g. neoplasm or dementia);
• Patients receiving IV tPA \> 3 hours from stroke onset;
• Bradycardia (heart rate ≤ 50);

Sponsors & Collaborators

• Life Recovery Systems: lead
• Tulane University School of Medicine: collaborator
• Geisinger Clinic: collaborator

Study Sites (4)

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

U of SC School of Medicine

Columbia, South Carolina, 29203, United States

Location

Related Publications (2)

• Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 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. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24.

  PMID: 29367334 BACKGROUND

• Salerian JA, Schock RB, Schirmer CM, Sen S, Martin-Schild S, Goren O, Kupas DF, Freedman RJ, Aysenne A. Therapeutic hypothermia with rapid thin liquid convection is safe and feasible in acute ischemic stroke patients: the SISCO pilot study. Front Neurol. 2025 Nov 7;16:1611794. doi: 10.3389/fneur.2025.1611794. eCollection 2025.

  PMID: 41281552 DERIVED

MeSH Terms

Conditions

Stroke; Brain Ischemia

Interventions

Magnesium Sulfate; Tissue Plasminogen Activator; Propofol; Etomidate

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Aimee Aysenne, M.D.

  Tulane University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2015
• First Posted: May 25, 2015
• Study Start: January 25, 2017
• Primary Completion: June 1, 2023
• Study Completion: June 2, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)