Combining cooling and thrombectomy for acute stroke treatment
Combination of Targeted Temperature Management and Thrombectomy After Acute Ischemic Stroke (COTTIS-2) - a Randomised Controlled Study
This study tests if cooling the body after a stroke helps people recover better when combined with a procedure to open blocked blood vessels.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Freiburg Academic / other |
| Locations | 1 site (Freiburg im Breisgau) |
| Trial ID | NCT06301412 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with acute ischemic stroke and significant neurological deficits who meet specific imaging and timing criteria.
Not a fit: Patients with intranasal obstructions or severe hemorrhagic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients with acute ischemic stroke.
How similar studies have performed: Previous studies have shown mixed results with hypothermia in stroke treatment, making this approach both innovative and necessary to explore further.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Freiburg im Breisgau
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.