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

NCT ID: NCT06335641

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-28

Study Completion Date

2025-02-24

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke, Acute

Keywords

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Hypothermia Large vessel occlusion Neuroprotection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment arm

Head cooling

Group Type EXPERIMENTAL

External active conductive head cooling

Intervention Type DEVICE

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

Interventions

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External active conductive head cooling

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

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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William Diprose

Clinical fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Foothills Medical Center

Calgary, Alberta, Canada

Site Status

Te Whatu Ora Te Toka Tumai Auckland

Auckland, , New Zealand

Site Status

Countries

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Canada New Zealand

Other Identifiers

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ACTRN12621001346864

Identifier Type: OTHER

Identifier Source: secondary_id

COOLHD24-CAN / A+10019

Identifier Type: -

Identifier Source: org_study_id