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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Stroke, Acute Body Temperature Changes Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypothermia Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Center, Calgary, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

External active conductive head cooling

Device

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

Primary outcomes

Adherence to the intervention

Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Acronym: COOLHEAD-2a

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Mar 28, 2024
Registry last updated: Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting