Combination of Hypothermia and Thrombectomy in Acute Stroke

Launched by UNIVERSITY OF FREIBURG · Mar 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients who have had an acute ischemic stroke caused by a blockage in a major blood vessel. The researchers want to find out if cooling the body temperature to 35°C, in addition to a procedure to remove the blockage (called thrombectomy), can improve recovery after the stroke. Participants in the trial will receive a noninvasive cooling treatment right after the blockage is reopened and will be kept cool for six hours before gradually warming back up. The researchers will compare the outcomes of patients receiving this cooling treatment with those who only receive the standard thrombectomy and medical care.

To be eligible for the trial, participants must be between the ages of 65 and 74, have had a stroke that is significant enough to require treatment, and have a good level of function before the stroke. Some conditions, like certain severe bleeding disorders or recent brain surgery, may prevent someone from participating. Those who join the trial can expect close monitoring throughout the process, with the goal of determining if the cooling treatment leads to better recovery outcomes without causing complications.

Gender

ALL

Eligibility criteria

• 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