Stroke, Acute
Conditions
Keywords
Hypothermia, Large vessel occlusion, Neuroprotection
Brief summary
This is an investigator-initiated, prospective, open-label, single-arm, non-randomized study to assess the safety and feasibility of external active conductive head cooling during endovascular thrombectomy procedures.
Interventions
DEVICEExternal active conductive head cooling
Cooling is applied during the endovascular thrombectomy procedure for a maximum of 120 minutes
Sponsors
University of Calgary
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- All patients with anterior circulation acute ischemic stroke planned to undergo endovascular thrombectomy will be screened for recruitment.
Exclusion criteria
* Admission core body temperature \<35°C. * Known contraindications to hypothermia, including hemodynamically unstable patients, new/symptomatic arrhythmia, hematological 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., resides outside of Alberta).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the intervention | From time of application in the emergency department until the end of the endovascular thrombectomy procedure | Adherence is defined as undergoing active conductive head cooling for ≥50% of the time from first application of the cooling device |
Countries
Canada, New Zealand
Outcome results
None listed