Helping Stroke Patients With ThermoSuit Cooling "SISCO"

Recruiting

Phase N/A Results N/A

Trial Description

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 two 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.

Detailed Description

Patients presenting to the emergency department with clinical signs and symptoms of acute ischemic stroke will undergo initial evaluation. The patient will be screened for study eligibility. A medical history and list of active medications will be documented. A physical will be conducted including the patient's temperature, hemodynamic and neurological status (NIHSS score), 12-lead ECG, and routine baseline laboratory values including magnesium, CBC, BMP, coagulation parameters, CK, CK-MB, and Troponin I. If all inclusion criteria and no exclusion criteria are present, a member of the research team will consult the patient's attending physician for permission to approach the patient. If he/she agrees, a member of the team will inform the patient or guardian about the study's purpose and obtain written informed consent. A screening log will be kept of all patients screened for this study and the reasons they were not enrolled.
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. Hypothermia will generally be initiated in the ED or ICU, as soon as possible after the informed consent has been obtained. However, in cases in which neurothrombectomy is indicated and judged by the investigators to be feasible to start within 90 minutes of enrollment, cooling will be delayed until its completion, and shall afterward be initiated as soon as possible. In all cases the patient will be placed in the LRS ThermoSuit in the supine position.
Cooling will be started as specified in the Operator's Manual for the ThermoSuit device. Core temperature will be measured and monitored through a nasopharyngeal temperature probe.
Cooling will be initiated by circulating ice-cold water (0-8°C ± 2.0°C) through the ThermoSuit, and the start time will be recorded. Patient core and TSS water temperatures will be electronically recorded. The patient will be cooled until the core temperature reaches between 32°C to 34°C. This will require approximately 5 to 20 minutes of cooling by the ThermoSuit device (not expected to be more than 30 minutes). Arterial blood pressure and heart rate will be recorded every 5 minutes from the baseline just before the start of cooling until 30 minutes after the cooling has started.
The clinician will be prompted by the automated monitor to purge the fluid from the suit when the patient's core temperature reaches approximately 34.5°C. The purging will take approximately 2 minutes. Start and stop times of purging will be recorded. The patient's body temperature should continue to decrease and then stabilize within the target range. The time at which the core temperature reaches 34°C will be recorded.
The patient will be removed from the ThermoSuit immediately after water finishes draining from the suit. The time of removal will be recorded.
Sedatives and analgesics will be administered for patient comfort as needed. Whether or not shivering occurs during cooling will be recorded, as well as start and stop times.
Body temperature will be maintained in the range of 32°C to 34°C for a period of 24 hours following the cooling induction using a cooling blanket system.
After 24 hours of therapeutic hypothermia, the patient will be re-warmed with the cooling/warming blanket until core body temperature reaches 36.5°C. This is anticipated to take approximately 8 hours.
All patients will be admitted to the intensive care unit for close monitoring of physiological parameters: blood pressure, heart rate and rhythm, arterial oxygen saturation, potassium level, acid-base balance, and indicators of infection. A head CT will be performed upon admission and 24-48 hours later. Neurological status over the first 24 hours will be closely monitored and accompanied by additional brain imaging if changes in the neurological status occur. In ICU level patients, neurological status will be evaluated q1hr with the mini-NIHSS (items 1a, 1b, 1c, and motor scores for each limb), Glasgow Coma Scale, and pupillary light response. In the case of deterioration, repeat imaging which will include CT or MRI will be performed within 48 hours to compare to admission studies. Blood pressure, heart rate and rhythm, cell count, electrolytes, magnesium, coagulation profile, cardiac enzymes, liver enzymes and serum amylase will be monitored. All neurological, cardiovascular, respiratory, digestive, hematological, and metabolic complications will be recorded and treated accordingly. Intubated patients (if any) will be extubated upon rewarming if their neurological status allows for safe extubation. NIHSS will be recorded daily, and prior to discharge.
Follow-Up on Day 5-7 post-treatment or at discharge (whichever comes first)
Records to be collected at this time will include those related to physical exam, patient temperature, hematology, clinical chemistry, ECG, blood pressure, heart rate, concomitant medications, results of any follow-up CT or MRI scans, NIHSS, Glasgow Coma Scale, pupillary light response, MRS, Quality of Life (Neuro-QOL), and any adverse events.
3 Month Follow Up
NIHSS, MRS, and Quality of Life (Neuro-QOL) will be calculated at 90 days (+/-10 days) post-stroke. Any additional adverse events will also be recorded at this time.

Conditions

Interventions

  • Propofol Drug
    Other Names: Diprivan
    Intervention Desc: Induction doses of propofol or etomidate will be used to aid in the suppression of patient discomfort
    ARM 1: Kind: Experimental
    Label: ThermoSuit Cooling Induction
    Description: 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. tPA will be given if indicated.
  • Magnesium sulfate Drug
    Other Names: Epsom salt; Magnesium sulphate
    Intervention Desc: Magnesium sulfate will be administered intravenously as needed to control shivering
    ARM 1: Kind: Experimental
    Label: ThermoSuit Cooling Induction
    Description: 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. tPA will be given if indicated.
  • ThermoSuit Cooling Induction Device
    Other Names: LRS ThermoSuit
    Intervention Desc: Rapid induction of therapeutic hypothermia (32-34 degrees C) using the Life Recovery Systems ThermoSuit System
    ARM 1: Kind: Experimental
    Label: ThermoSuit Cooling Induction
    Description: 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. tPA will be given if indicated.
  • TPA Drug
    Other Names: Tissue plasminogen activator
    Intervention Desc: tPA will be administered intravenously if indicated
    ARM 1: Kind: Experimental
    Label: ThermoSuit Cooling Induction
    Description: 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. tPA will be given if indicated.
  • Etomidate Drug
    Other Names: Amidate
    Intervention Desc: Induction doses of propofol or etomidate will be used to aid in the suppression of patient discomfort
    ARM 1: Kind: Experimental
    Label: ThermoSuit Cooling Induction
    Description: 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. tPA will be given if indicated.
  • Neurothrombectomy Procedure
    Other Names: Endovascular Thrombectomy
    Intervention Desc: If indicated, neurothrombectomy will be performed using an FDA-cleared device within the FDA-cleared treatment window.
    ARM 1: Kind: Experimental
    Label: ThermoSuit Cooling Induction
    Description: 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.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Feasibility of cooling as indicated by percentage of patients cooled to target within 1 hour of start of cooling 1 hour after start of cooling No
Primary Neurological outcome as indicated by NIHSS Hospital discharge or day 5-7 post-treatment (whichever comes first) No
Primary Safety of the cooling treatment as indicated by rates of significant adverse events 30 days Yes
Primary Neurological outcome as indicated by MRS score Hospital discharge or day 5-7 post-treatment (whichever comes first) No
Primary Change in neurological outcome as indicated by NIHSS Hospital discharge or 5-7 days post-treatment (whichever comes first) and 90 +/- 10 days post-stroke No
Primary Change in neurological status as indicated by MRS Hospital discharge or 5-7 days post-treatment (whichever comes first) and 90 +/- 10 days post-stroke No
Secondary Mortality 90 days Yes
Secondary 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 No
Secondary Rates of procedure and device related SAEs 0 to 90 days Yes

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