I63
Conditions
Interventions
Group 1: Intervention: Immediately induced hypothermia to 35°C (measured esophagially) by transnasal colling with RhinoChill prior to thrombectomy followed by surface cooling for 6 hours after recanal
Sponsors
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: o Pre-stroke modified Rankin Scale (mRS) 0-2 o Acute ischemic stroke with NIHSS >5 o Indication for endovascular treatment (thrombectomy) o Intracranial occlusion of the M1 or M2 segment of the middle cerebral artery (MCA) or internal carotid artery (ICA) or tandem occlusion on CT-angiography or MR-angiography o Time window: -Last seen normal to groin puncture 5 -Last seen normal to groin puncture 6-24h or unknown time window: significant mismatch imaging according to the eligibility criteria of the DEFUSE-3 trial: - Infarct core 15ml (Tmax >6sec) - Ratio penumbra/core >1.8 o with or without iv thrombolysis with rtPA
Exclusion criteria
Exclusion criteria: o Patients with an intranasal obstruction that prevents complete insertion of the nasal cannula should not be treated with the RhinoChill system. o Known severe hemorrhagic diathesis (International Normalized Ratio (INR) >3.0, partial thromboplastin time (PTT) > 70s, platelet count < 50.000/µl) o Brain trauma or neurovascular surgery/intervention <3 months o Severe infection o Pregnant women or women of childbearing potential (women of childbearing potential with negative pregnancy test may be included) o Known cerebral vasculitis o Proof of bleeding in cerebral CT or MRI (cerebral microbleeds in MRI [hypertensive or in the context of cerebral amyloid angiopathy] is permitted). o Life expectancy < 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with good neurological outcome after 3 months as defined by modified Rankin Scale (mRS) of 0-2 or back to baseline before stroke. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Infarction volume assessed in the standard CT 24 hours after thrombectomy 2) Increase of the infarct core based on imaging at the time of admission (DWI-MRI or CBF30% of initial infarction volume associated with a clinical deterioration in NIHSS score of at least 4 points within 24 hours after thrombectomy 2. Complications associated with additional hypothermia treatment : [Time span: from start of hypothermia to 24 hours after induction of cooling] - Nosebleed and pailing of the nose - Periorbital emphysema - Pneumocephalus (in 24-hour control CT) - Blood pressure, heart rate, oxygen saturation SO2 - Episodes with severe hypotension with systolic blood pressure 38°C, leukopenia/leucocytosis, purulent secretions with positive cultures) - Disturbances in electrolytes, renal function, coagulation (potassium, sodium, chloride, creatinine, INR, pTT, thrombocytes measured on admission before hypothermia and at 24 hours) | — |
Countries
Germany
Contacts
Public ContactJürgen Bardutzky
Neurologie, Universität Freiburg
Outcome results
None listed