Head COOLing in IscHemic Stroke Patients Undergoing EndovAscular Thrombectomy: a Feasibility and Safety StuDy

N/AActive Not RecruitingNCT06335641

University of Calgary40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke, Acute

Interventions

External active conductive head coolingDEVICE

Cooling is applied during the endovascular thrombectomy procedure for a maximum of 120 minutes

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (2)

Foothills Medical Center

Calgary, Alberta, Canada

Te Whatu Ora Te Toka Tumai Auckland

Auckland, New Zealand

Outcomes

Primary Outcomes

Adherence to the intervention

Adherence is defined as undergoing active conductive head cooling for ≥50% of the time from first application of the cooling device

Time frame: From time of application in the emergency department until the end of the endovascular thrombectomy procedure

Data from ClinicalTrials.gov

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