COmbination of Targeted temperature management and Thrombectomy after acute Ischemic Stroke (COTTIS) – a pilot feasibility and safety study

Not Applicable

• Conditions: I63; Cerebral infarction

• Registration Number: DRKS00023573
• Lead Sponsor: eurologisches Universitätsklinikum Freiburg

Brief Summary

Twenty-two patients (median age, 77 years) were included in the study (14 received additional thrombolysis, 4 additional stenting of the proximal internal carotid artery). The median time intervals were 309 min for last-seen-normal-to-groin, 58 min for door-to-cooling-initiation, 65 min for door-to-groin and 123 min for door-to-recanalisation. The target temperature of 35°C was reached within 30 min (range 13-78 min), corresponding to a cooling rate of 2.6 °C/hour. On recanalisation, 86% of the patients had a body temperature of =35°C. The median National Institutes of Health Stroke Scale at admission was 15 and improved to 2 by day 7, and 68% of patients had a good outcome (modified Rankin Scale 0-2) at 3 months. Postprocedure complications included asymptomatic bradycardia (32%), pneumonia (18%) and asymptomatic haemorrhagic transformation (18%).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-11
• Study Completion: 2022-08-19
• Results First Posted: 2023-08-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1) All patients with occlusion of proximal vessels in the anterior circulation during 24 h of stroke onset and indication for thrombectomy according to DGN/ ESO guidelines
2) age over 18 years old
3) patients are allowed to receive intravenous thrombolysis before thrombectomy
4) no severe disability before ischemic stroke (mRS = 1)

Exclusion Criteria

1) Known coagulopathy, oral anticoagulants INR > 3,0
2) platelet count<50.000/µl
3.) blood glucose < 50mg/dL or >400mg/dl
4) persistently high blood pressure systolic > 220 mmHg or diastolic > 110 mmHg despite analgosedation and antihypertensive drugs
5) severe advanced disease, life expectancy < 1 year
6) patients with large operation, neurosurgical operation, percutaneous, cardial or vascular intervention within 72h before stroke onset
7) pregnant women or women of childbearing age (women of childbearing age with negative pregnancy test can be included in the study)
8) patient who participate in another clinical study
9) known cerebral vasculitis
10) previous physical, mental, psychiatric or neurological disease (mRS >1)
11) Evidence of bleeding in cerebral CT or MRT (cerebral microbleeds due to hypertension or cerebral amyloid angiopathy are allowed)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time since reaching target temperature (35 °C, measured esophageally)

Secondary Outcome Measures

Name	Time	Method
1) infarct volume in standard CT imaging 24 hours after thrombectomy<br>2) modification / increase of infarct core in CT imaging comparing hospital admission and after 24 hours<br>3) result of recanalisation after thrombectomy (TICI-Score, based on angiography during / after thrombectomy) and after 24 hours (based on ultrasound of the brain-supplying vessels)<br>4) NIHSS during hospital admission process, date of leaving the hospital/transfer to rehabilition) <br>5) mRS at date of leaving the hospital/transfer to rehabilition and after 3 months (regular meeting at stroke-aftercare-ambulance at Freiburg or by telephone if desired) <br>6) proportion of patients with excellent clinical outcome after 3 months (mRS 0-1)<br>7) mortality during acute inpatient care and after 3 months <br>8) temperature profile at different measurement spots (esophageal, tympan, bladder, forehead)