None listed
Conditions
Brief summary
Stroke is a major cause of disability and death and is caused by blood clots blocking arteries in the brain. Clot retrieval, whereby the blood clot is removed with a minimally invasive procedure, significantly reduces disability after stroke. Unfortunately, many patients suffer irreversible brain damage before the clot is removed due to transport delays from regional to clot-retrieval capable hospitals. Lowering brain temperature during transport may slow brain damage and lead to better outcomes. This study will examine whether it is feasible to use a cooling cap in adult stroke patients treated with clot retrieval.
Interventions
A non-invasive head cooling device* will be applied to the participants' head from the time of enrolment at the participating hospital's emergency department, until the completion of the endovascular clot retrieval. Head cooling will be administered by a clinician with a background in internal medicine/neurology or anaesthesia. The duration of the intervention will therefore range between 30 minutes and 2 hours, depending on the duration of the endovascular clot retrieval. During the cooling per
A non-invasive head cooling device* will be applied to the participants' head from the time of enrolment at the participating hospital's emergency department, until the completion of the endovascular clot retrieval. Head cooling will be administered by a clinician with a background in internal medicine/neurology or anaesthesia. The duration of the intervention will therefore range between 30 minutes and 2 hours, depending on the duration of the endovascular clot retrieval. During the cooling period, the participant will have their core body temperature measured with a nasopharyngeal temperature probe, along with standard anaesthetic monitoring, including non-invasive heart rate and blood pressure measurements, and usually intra-arterial blood pressure measurements. The procedural anaesthetist will be responsible for monitoring these parameters. *The non-invasive head cooling device will be one of either The WElkins Temperature Regulation System, 2nd Gen, or the Orbis Paxman System. Both devices are thermoregulatory systems that automatically reduces and maintains the temperature of coolant within a flexible cap. The coolant has a target temperature of -4 to -5°C, which results in heat exchange between the participant and the coolant.
Sponsors
Professor P. Alan Barber
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with anterior circulation large vessel occlusion stroke (internal carotid artery, M1 or proximal M2 segments of the middle cerebral artery) where endovascular clot retrieval is planned.
Exclusion criteria
- Pre-stroke modified Rankin Scale score >2 - BP >=185/110 mmHg not responsive to guideline-directed intravenous antihypertensive therapy - Admission core body temperature <35°C - Known contraindications to hypothermia, including haematological dyscrasias that affect thrombosis (cryoglobulinemia, sickle cell disease, serum cold agglutinins), or vasospastic disorders such as Raynaud's or thrombo-angiitis obliterans - Skin lesions not allowing secure application of the cooling cap - Unable to participate in follow-up at 3 months (e.g., travelling overseas) - Terminal illness with expected survival <1 year
Outcome results
None listed