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โ† Trials
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Combination of Hypothermia and Thrombectomy in Acute Stroke

RecruitingPhase 3Ages 18 Years - anyAllUniversity of Freiburg
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to test the combination of hypothermia and endovascular treatment in acute stroke patients with large vessel occlusion. The main question it aims to answer is: does an additional cooling to 35ยฐC result in a benefit on clinical outcome ? Participants receive immediate cooling using a noninvasive transnasal cooling technique (RhonoChill) and are maintained at 35ยฐC for 6 hours after reopening of the vessel using surface cooling, and then slowly rewarmed. Researchers will compare the intervention group (hypothermia and endovascular treatment and best medical treatment including iv thrombolysis) and control group (only endovascular treatment and best medical treatment including iv thrombolysis) to see if additional hypothermia leads to a better outcome after 3 months without relevant complications.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Pre-stroke modified Rankin Scale (mRS) 0-2 \[7-point scale rating from 0 (no symptoms) to 6 (dead)\] * Acute ischemic stroke with NIHSS \>5 * 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 with indication for endovascular treatment: * Time window 0-24h: 1. Last seen normal to groin puncture \< 6h: native CT or MRI-DWI with ASPECTS \>5 2. 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 \<70ml (DWI oder CBF\<30%) * Penumbra \> 15ml (Tmax \>6sec) * Ratio penumbra/core \>1.8 * with or without iv thrombolysis with rtPA Exclusion Criteria: * Patients with an intranasal obstruction that prevents complete insertion of the nasal cannula should not be treated with the RhinoChill system. * Known severe hemorrhagic diathesis (International Normalized Ratio (INR) \>3.0, partial thromboplastin time (PTT) \> 70s, platelet count \< 50.000/ฮผl) * Brain trauma or neurovascular surgery/intervention \<3 months * Severe infection * Pregnant women or women of childbearing potential (women of childbearing potential with negative pregnancy test may be included) * Known cerebral vasculitis * Proof of bleeding in cerebral CT or MRI (cerebral microbleeds in MRI \[hypertensive or in the context of cerebral amyloid angiopathy\] is permitted). * Known life expectancy \< 6 months
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What it tests

  • hypothermia
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Where

1 site
University of Freiburg, Department of Neurology
Freiburg im Breisgau, Germany
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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