hypothermia: hypothermia is started after intubation for endovascular treatment and induced by transnasal cooling (RhinoChill) to a target temperature of 35°C and hypothermia is then maintained at 35°C for 6 hours after recanalisation by surface cooling followed by slow rewarming by 0.2°C per hour to 36.5°C
Study summary
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 35°C result in a benefit on clinical outcome ? Participants receive immediate cooling using a noninvasive transnasal cooling technique (RhonoChill) and are maintained at 35°C 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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/μl)
* 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
Primary outcome measure(s)
functional outcome — 3 months The presence of patients with good neurological outcome after 3 months as defined by modified Rankin Scale (mRS; on which scores range from 0 to 6, with 0 means no symptoms and 6 means death) of 0-2 or back to baseline before stroke
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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