- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06335641
Head COOLing in iscHemic Stroke Patients Undergoing EndovAscular Thrombectomy: a Feasibility and Safety stuDy (COOLHEAD-2-CAN)
March 21, 2024 updated by: Mohammed A Almekhlafi, University of Calgary
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohammed Almekhlafi
- Phone Number: 4039331883
- Email: mohammed.almekhlafi1@ucalgary.ca
Study Contact Backup
- Name: William Diprose
- Email: william.diprose@ucalgary.ca
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment arm
Head cooling
|
Cooling is applied during the endovascular thrombectomy procedure for a maximum of 120 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to the intervention.
Time Frame: The end of the EVT procedure.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2024
Primary Completion (Estimated)
April 1, 2026
Study Completion (Estimated)
April 1, 2026
Study Registration Dates
First Submitted
March 21, 2024
First Submitted That Met QC Criteria
March 21, 2024
First Posted (Actual)
March 28, 2024
Study Record Updates
Last Update Posted (Actual)
March 28, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COOLHD24-CAN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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