Helping Stroke Patients With ThermoSuit Cooling

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Life Recovery Systems
• Collaborators: Geisinger Clinic; Tulane University School of Medicine
• Treatments: Etomidate; Magnesium Sulfate; Plasminogen; Propofol; Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

• 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).

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 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 or diastolic blood pressure >110 mmHg 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 and elevated aPTT (greater than upper limit of normal for laboratory)

• Current use of oral anticoagulants (ex: warfarin) and INR >1.7;

• Current use of direct thrombin inhibitors or direct factor Xa inhibitors

• 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

• Abnormal blood glucose (<50 or >400 mg/dL)

• Suspected/confirmed endocarditis

Exclusions for Patients Receiving Neurothrombectomy >

• Patients with known hypersensitivity to nickel-titanium

• Patients with stenosis and/or pre-existing stent proximal to the thrombus site that may preclude safe recovery of the revascularization device

• Patients with angiographic evidence of carotid dissection