Combination of Targeted temperature management and Thrombectomy after acute Ischemic Stroke (COTTIS-2) – a randomised controlled study

Phase 3

Recruiting

• Conditions: I63; Cerebral infarction

• Registration Number: DRKS00031086
• Lead Sponsor: niversitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

oPre-stroke modified Rankin Scale (mRS) 0-2
oAcute ischemic stroke with NIHSS >5
oIndication for endovascular treatment (thrombectomy)
oIntracranial 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
oTime window:
-Last seen normal to groin puncture < 6h: native CT or MRI-DWI with Alberta Stroke Program Early CT score (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% of contralateral site)
- Penumbra > 15ml (Tmax >6sec)
- Ratio penumbra/core >1.8
owith or without iv thrombolysis with rtPA

Exclusion Criteria

oPatients with an intranasal obstruction that prevents complete insertion of the nasal cannula should not be treated with the RhinoChill system.
oKnown severe hemorrhagic diathesis (International Normalized Ratio (INR) >3.0, partial thromboplastin time (PTT) > 70s, platelet count < 50.000/µl)
oBrain trauma or neurovascular surgery/intervention <3 months
oSevere infection
oPregnant women or women of childbearing potential (women of childbearing potential with negative pregnancy test may be included)
oKnown cerebral vasculitis
oProof of bleeding in cerebral CT or MRI (cerebral microbleeds in MRI [hypertensive or in the context of cerebral amyloid angiopathy] is permitted).
oLife expectancy < 6 months

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients with good neurological outcome after 3 months as defined by modified Rankin Scale (mRS) of 0-2.