Combination of Hypothermia and Thrombectomy in Acute Stroke
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Freiburg
About this trial
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 criteria
Qualifiers
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
Last seen normal to groin puncture < 6h: native CT or MRI-DWI with ASPECTS >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
Disqualifiers
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
Trial design
Treatments tested in this trial
- hypothermia
Treatment groups
400 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Freiburg
Lead sponsor
European Union
Collaborator
E+E CRO consulting, Vienna, Austria
Collaborator
Center for Medical data science, University of Vienna, Austria
Collaborator
Source ClinicalTrials.gov