Head COOLing in IscHemic Stroke Patients Undergoing EndovAscular Thrombectomy: a Feasibility and Safety StuDy (COOLHEAD-2a)

University of Calgary

Status: Active, not recruiting

Conditions: Stroke, Acute

Treatments: Device: External active conductive head cooling

Study type: Interventional

Funder types: Other

Identifiers

NCT06335641

COOLHD24-CAN / A+10019

ACTRN12621001346864 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Treatment arm

Experimental group

Description:

Head cooling

Treatment:

Device: External active conductive head cooling