Head cooling in stroke clot retrieval.

Not Applicable

Recruiting

Conditions: Stroke - Ischaemic
Ischaemic stroke.

Registration Number: ACTRN12621001346864

Lead Sponsor: Professor P. Alan Barber

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 40

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of recruited participants that are ‘adherent’ to the intervention. Adherence is defined as having a delivered temperature of <=0°C for >=50% of the time from application in the Emergency Department to the end of the endovascular clot retrieval. The delivered temperature is the temperature of the coolant in the unit’s reservoir and reflects the<br>actual temperature delivered to the participant. This is automatically measured by the cooling unit.[ Endovascular clot retrieval completion.]

Secondary Outcome Measures

Name	Time	Method
Recruitment rate (proportion of all eligible patients who are enrolled over the study duration) will be collected by auditing the study records.[ Study completion.];Core body temperature will be measured with an indwelling urinary catheter. The catheter will be connected to an anaesthetic monitoring unit that continuously stores the temperature data.[ Endovascular clot retrieval completion.]