Helping Stroke Patients With ThermoSuit Cooling "SISCO"


Phase N/A Results N/A

Eligibility Criteria

Inclusion Criteria

- Ischemic cortical stroke with NIHSS > _5_;
- 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 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