Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 or esophageal 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 33.5°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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02453373
Study type Interventional
Source Life Recovery Systems
Contact
Status Terminated
Phase N/A
Start date January 25, 2017
Completion date June 2, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04101695 - Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects N/A
Suspended NCT03869138 - Alternative Therapies for Improving Physical Function in Individuals With Stroke N/A
Completed NCT04034069 - Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial N/A
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT06204744 - Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial N/A
Active, not recruiting NCT06043167 - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Enrolling by invitation NCT04535479 - Dry Needling for Spasticity in Stroke N/A
Completed NCT03985761 - Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT06034119 - Effects of Voluntary Adjustments During Walking in Participants Post-stroke N/A
Completed NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT05854485 - Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke N/A
Active, not recruiting NCT05520528 - Impact of Group Participation on Adults With Aphasia N/A
Active, not recruiting NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Completed NCT05805748 - Serious Game Therapy in Neglect Patients N/A
Recruiting NCT05621980 - Finger Movement Training After Stroke N/A