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NCT06335641 Clinical Trial

Head COOLing in iscHemic Stroke Patients Undergoing EndovAscular Thrombectomy: a Feasibility and Safety stuDy

Stroke, Acute Clinical Trial

— COOLHEAD-2-CAN  

Official title:
Head COOLing in iscHemic Stroke Patients Undergoing EndovAscular Thrombectomy: a Feasibility and Safety stuDy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06335641
Other study ID # COOLHD24-CAN
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date April 1, 2026

Study information
Verified date March 2024
Source University of Calgary
Contact Mohammed Almekhlafi
Phone 4039331883
Email mohammed.almekhlafi1@ucalgary.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date April 1, 2026
Est. primary completion date April 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients with acute ischemic stroke planned to undergo EVT 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).

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• External active conductive head cooling
Cooling is applied during the endovascular thrombectomy procedure for a maximum of 120 minutes

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Calgary

Outcome
Type Measure Description Time frame Safety issue
Primary 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 The end of the EVT procedure.
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