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
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Acute

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.