Cooling Plus Clot Removal Tested in Acute Stroke Patients
Tests cooling the body to 35°C alongside clot removal in adults with acute stroke.
Plain-language title generated from the registry record
Registry title: Combination of Hypothermia and Thrombectomy in Acute Stroke
Key facts
- Where
- Freiburg im Breisgau, GermanySee the site
- Phase
- Phase 3
Where in Germany
- University of Freiburg, Department of NeurologyFreiburg im Breisgau, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Freiburg
- Trial code
- NCT06301412
- Record updated
- 6 January 2025
- Original description
The goal of this clinical trial is to test the combination of hypothermia and endovascular treatment in acute stroke patients with large vessel occlusion.Read full original descriptionShow less
Combination of Targeted Temperature Management and Thrombectomy After Acute Ischemic Stroke (COTTIS-2) - a Randomised Controlled Study
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.
Inclusion: 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:; 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; Infarct core <70ml (DWI oder CBF<30%); Penumbra > 15ml (Tmax >6sec); Ratio penumbra/core >1.8; with or without iv thrombolysis with rtPA.
Exclusion: Patients with an intranasal obstruction that prevents complete insertion of the nasal cannula should not be treated with the RhinoChill system; Brain trauma or neurovascular surgery/intervention <3 months; Severe infection; Proof of bleeding in cerebral CT or MRI (cerebral microbleeds in MRI [hypertensive or in the context of cerebral amyloid angiopathy] is permitted); Known severe hemorrhagic diathesis (International Normalized Ratio (INR) >3.0, partial thromboplastin time (PTT) > 70s, platelet count < 50.000/μl); Pregnant women or women of childbearing potential (women of childbearing potential with negative pregnancy test may be included); Known cerebral vasculitis; Known life expectancy < 6 months.