Combining cooling and thrombectomy for acute stroke treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of combining hypothermia with endovascular treatment in patients suffering from acute ischemic stroke due to large vessel occlusion. Participants will undergo a noninvasive cooling technique to lower their body temperature to 35°C for six hours following the reopening of the blocked vessel. The study aims to determine if this additional cooling improves clinical outcomes compared to standard treatment alone. Researchers will compare results from two groups: one receiving both hypothermia and endovascular treatment, and the other receiving only endovascular treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Freiburg, Department of Neurology
  Freiburg im Breisgau, Germany Recruiting

Study contacts

• Principal investigator: Juergen Bardutzky, Prof. — University of Freiburg, Department of Neurology, Germany
• Study coordinator: Juergen Bardutzky, Prof.
• Email: juergen.bardutzky@uniklinik-freiburg.de
• Phone: +49-15237729739

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.