NCT06301412RecruitingPhase 3
Combination of Hypothermia and Thrombectomy in Acute Stroke
Combination of Targeted Temperature Management and Thrombectomy After Acute Ischemic Stroke (COTTIS-2) - a Randomised Controlled Study
Source: ClinicalTrials.gov · Last updated 6 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 22 Feb 2024
- Start date
- 7 Jul 2024
- Primary completion date
- 18 Mar 2026
- Lead sponsor
- University of Freiburg
- Diseases
- Stroke
- NCT number
- NCT06301412
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 400
- From 7 Jul 2024 to the primary completion date, 18 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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).
Lab values
- Known severe hemorrhagic diathesis (International Normalized Ratio (INR) \>3.0, partial thromboplastin time (PTT) \> 70s, platelet count \< 50.000/μl)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Freiburg, Department of Neurology Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.