Helping Stroke Patients With ThermoSuit Cooling
Information source: Life Recovery Systems
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stroke; Brain Ischemia
Intervention: ThermoSuit Cooling Induction (Device); Magnesium Sulfate (Drug); tPA (Drug); Propofol (Drug); Etomidate (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Life Recovery Systems Official(s) and/or principal investigator(s): Sheryl Martin-Schild, M.D., Principal Investigator, Affiliation: Tulane University
Overall contact: Robert B Schock, Ph.D., Phone: 973-283-2800, Ext: 201, Email: bschock@life-recovery.com
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 two clinical centers. Subjects will receive hypothermia plus conventional therapy
(such as IV-tPA therapy if indicated). Endpoints will include feasibility of cooling,
adverse events, and neurological recovery in comparison with matched historical controls.
Clinical Details
Official title: Helping Stroke Patients With ThermoSuit Cooling
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Feasibility of cooling as indicated by percentage of patients cooled to target within 1 hour of start of coolingNeurological outcome as indicated by NIHSS Safety of the cooling treatment as indicated by rates of significant adverse events Neurological outcome as indicated by MRS score Change in neurological outcome as indicated by NIHSS Change in neurological status as indicated by MRS
Secondary outcome: MortalityQuality of Life as indicated by Neuro-QOL score Rates of procedure and device related SAEs
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 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 be initiated in the ED, immediately after the informed consent has been
obtained. 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 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, 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Ischemic cortical stroke with NIHSS > _5_and less than 24;
- Treatment initiated within 8 hours from known time of onset;
- Patient dimension criteria: Height: 147-190 cm (58 - 75 in) Width: ≤66 cm (26 in)
(elbow to elbow).
Exclusion Criteria:
- 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 neurothrombectomy;
- Patients receiving IV tPA > 3 hours from stroke onset;
- Bradycardia (heart rate ≤ 50);
- High degree AV block;
- Ventricular tachycardia;
- Ventricular fibrillation.
- Significant hypotension < 120 mm Hg, regardless of the underlying cause
Exclusions for Patients to receive IV tPA :
- Suspicion of subarachnoid hemorrhage on pretreatment evaluation, even with normal
neuroimaging;
- Systolic blood pressure greater than 185 mm of Hg at the time of t-PA infusion and/or
patient requires aggressive treatment to reduce blood pressure to within these
limits;
- Seizure at onset of stroke;
- Active internal bleeding;
- Known bleeding diathesis, including but not limited to:
- Platelet count less than 100,000/mm3
- Heparin during the preceding 48 hours
- Current use of oral anticoagulants;
- Elevated prothrombin time (PT) greater than 15 seconds.
- Major surgery or other serious trauma during preceding 14 days;
- Intercranial or intraspinal surgery, stroke, serious head trauma during preceding 3
months;
- Recent arterial puncture at a non-compressible site;
- Recent lumbar puncture during preceding 7 days;
- History of intracranial hemorrhage, neoplasm, arteriovenous malformation, or
aneurysm;
- Recent Acute Myocardial Infarction
Locations and Contacts
Robert B Schock, Ph.D., Phone: 973-283-2800, Ext: 201, Email: bschock@life-recovery.com
CHRISTUS St. Frances Cabrini Medical Center, Alexandria, Louisiana 71301, United States; Not yet recruiting Gonzalo I Hidalgo, M.D., Phone: 318-443-0490, Email: hidalgo.neuromed@gmail.com Gabe Johnson, Phone: (318) 443-0490, Email: gabealan@hotmail.com
Tulane University, New Orleans, Louisiana 70112, United States; Not yet recruiting Sheryl Martin-Schild, M.D., Phone: 504-988-9190, Email: smartin2@tulane.edu Cheryl Carmody, R.N., M.S., Phone: 504-988-9198, Email: ccarmody@tulane.edu
Additional Information
Starting date: August 2015
Last updated: May 20, 2015
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