Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001346864
Ethics application status
Approved
Date submitted
6/09/2021
Date registered
7/10/2021
Date last updated
24/11/2024
Date data sharing statement initially provided
7/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Head cooling in stroke clot retrieval.
Scientific title
Head COOLing in iscHemic Stroke Patients Undergoing EndovAscular Thrombectomy: a Feasibility and Safety stuDy (COOLHEAD-2)
Secondary ID [1] 305230 0
Nil known.
Secondary ID [2] 313395 0
NCT06335641
Universal Trial Number (UTN)
Trial acronym
COOLHEAD-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischaemic stroke. 323510 0
Condition category
Condition code
Stroke 321072 321072 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A non-invasive head cooling device* will be applied to the participants' head from the time of enrolment at the participating hospital's emergency department, until the completion of the endovascular clot retrieval. Head cooling will be administered by a clinician with a background in internal medicine/neurology or anaesthesia. The duration of the intervention will therefore range between 30 minutes and 2 hours, depending on the duration of the endovascular clot retrieval. During the cooling period, the participant will have their core body temperature measured with a nasopharyngeal temperature probe, along with standard anaesthetic monitoring, including non-invasive heart rate and blood pressure measurements, and usually intra-arterial blood pressure measurements. The procedural anaesthetist will be responsible for monitoring these parameters.

*The non-invasive head cooling device will be one of either The WElkins Temperature Regulation System, 2nd Gen, or the Orbis Paxman System. Both devices are thermoregulatory systems that automatically reduces and maintains the temperature of coolant within a flexible cap. The coolant has a target temperature of -4 to -5°C, which results in heat exchange between the participant and the coolant.
Intervention code [1] 321628 0
Treatment: Devices
Comparator / control treatment
Not applicable.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328847 0
The proportion of recruited participants that are ‘adherent’ to the intervention. Adherence is defined as having head cooling successfully administered for >=50% of the time from application in the Emergency Department to the end of the endovascular clot retrieval.
Timepoint [1] 328847 0
Endovascular clot retrieval completion.
Secondary outcome [1] 400633 0
Recruitment rate (proportion of all eligible patients who are enrolled over the study duration) will be collected by auditing the study records.
Timepoint [1] 400633 0
Study completion.
Secondary outcome [2] 401366 0
Core body temperature will be measured with a nasopharyngeal temperature probe. The probe will be connected to an anaesthetic monitoring unit that continuously stores the temperature data.
Timepoint [2] 401366 0
Endovascular clot retrieval completion.

Eligibility
Key inclusion criteria
Patients with anterior circulation large vessel occlusion stroke (internal carotid artery, M1 or proximal M2 segments of the middle cerebral artery) where endovascular clot retrieval is planned.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pre-stroke modified Rankin Scale score >2
- BP >=185/110 mmHg not responsive to guideline-directed intravenous antihypertensive
therapy
- Admission core body temperature <35°C
- Known contraindications to hypothermia, including haematological 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., travelling overseas)
- Terminal illness with expected survival <1 year

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Who is / are masked / blinded?



Intervention assignment
Other design features
This is a feasibility study.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
28/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
40
Final
Recruitment outside Australia
Country [1] 24099 0
New Zealand
State/province [1] 24099 0
Auckland
Country [2] 26733 0
Canada
State/province [2] 26733 0
Alberta

Funding & Sponsors
Funding source category [1] 317292 0
Charities/Societies/Foundations
Name [1] 317292 0
Neurological Foundation of New Zealand
Country [1] 317292 0
New Zealand
Primary sponsor type
Individual
Name
Professor P. Alan Barber
Address
Department of Medicine, Faculty of Medical and Health Sciences, The University of
Auckland, Private Bag 92019, Auckland 1142, New Zealand.
Country
New Zealand
Secondary sponsor category [1] 310620 0
None
Name [1] 310620 0
Address [1] 310620 0
Country [1] 310620 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309380 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 309380 0
Ethics committee country [1] 309380 0
New Zealand
Date submitted for ethics approval [1] 309380 0
13/09/2021
Approval date [1] 309380 0
14/12/2021
Ethics approval number [1] 309380 0

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

Contacts
Principal investigator
Name 113954 0
Dr William K Diprose
Address 113954 0
Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Private Bag 92019, Auckland 1023, New Zealand.
Country 113954 0
New Zealand
Phone 113954 0
+6499236520
Fax 113954 0
Email 113954 0
william.diprose@auckland.ac.nz
Contact person for public queries
Name 113955 0
William K Diprose
Address 113955 0
Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Private Bag 92019, Auckland 1023, New Zealand.
Country 113955 0
New Zealand
Phone 113955 0
+6499236520
Fax 113955 0
Email 113955 0
william.diprose@auckland.ac.nz
Contact person for scientific queries
Name 113956 0
William K Diprose
Address 113956 0
Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Private Bag 92019, Auckland 1023, New Zealand.
Country 113956 0
New Zealand
Phone 113956 0
+6499236520
Fax 113956 0
Email 113956 0
william.diprose@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data can be shared for the purposes of stroke research if participants opt in.
When will data be available (start and end dates)?
Following the publication of the study until 10 years after study completion.
Available to whom?
On a case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Stroke research.
How or where can data be obtained?
From the Primary Sponsor, Professor P. Alan Barber.

Email address: a.barber@auckland.ac.nz


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.