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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06335641




Registration number
NCT06335641
Ethics application status
Date submitted
21/03/2024
Date registered
28/03/2024

Titles & IDs
Public title
Head COOLing in IscHemic Stroke Patients Undergoing EndovAscular Thrombectomy: a Feasibility and Safety StuDy
Scientific title
Head COOLing in IscHemic Stroke Patients Undergoing EndovAscular Thrombectomy: a Feasibility and Safety StuDy
Secondary ID [1] 0 0
ACTRN12621001346864
Secondary ID [2] 0 0
COOLHD24-CAN
Universal Trial Number (UTN)
Trial acronym
COOLHEAD-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke, Acute 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - External active conductive head cooling

Experimental: Treatment arm - Head cooling


Treatment: Devices: External active conductive head cooling
Cooling is applied during the endovascular thrombectomy procedure for a maximum of 120 minutes
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adherence to the intervention
Timepoint [1] 0 0
From time of application in the emergency department until the end of the endovascular thrombectomy procedure

Eligibility
Key inclusion criteria
- All patients with anterior circulation acute ischemic stroke planned to undergo endovascular thrombectomy will be screened for recruitment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/02/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Calgary
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Mohammed Almekhlafi
Address 0 0
Country 0 0
Phone 0 0
4039331883
Fax 0 0
Email 0 0
mohammed.almekhlafi1@ucalgary.ca
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06335641