COmbination of Targeted temperature management and Thrombectomy after acute Ischemic Stroke (COTTIS) – a pilot feasibility and safety study - COTTIS
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 22
Study Overview
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%).
Study Design
- Study Type
- Interventional
- Allocation
- N/a: Single Arm Study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
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)