Stroke, AcuteCOOLHEAD-2aNCT06335641
Head COOLing in IscHemic Stroke Patients Undergoing EndovAscular Thrombectomy: a Feasibility and Safety StuDy
A study testing External active conductive head cooling in people with Stroke, Acute, run by University of Calgary at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- External active conductive head cooling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Jul 2024to 24 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with anterior circulation acute ischemic stroke planned to undergo endovascular thrombectomy will be screened for recruitment.
Who cannot join
- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
- Conditions
- Stroke, Acute
- Being tested
- External active conductive head cooling
- Keywords
- Hypothermia, Large vessel occlusion, Neuroprotection
- Medical subject headings
- Stroke, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External active conductive head coolingDevice
Cooling is applied during the endovascular thrombectomy procedure for a maximum of 120 minutes
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Head cooling Receives: Device: External active conductive head cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From time of application in the emergency department until the end of the endovascular thrombectomy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start28 Jul 2024
- Primary completion24 Nov 2024
- Study completion24 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Diprose, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335641
- Sponsor's protocol ID
- COOLHD24-CAN / A+10019
- Other IDs
- ACTRN12621001346864
- Acronym
- COOLHEAD-2a
- Status last verified
- Dec 2024
- First submitted
- 21 Mar 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head COOLing in IscHemic Stroke Patients Undergoing EndovAscular Thrombectomy: a Feasibility and Safety StuDy
- ClinicalTrials.gov ID
- NCT06335641
- Acronym / sponsor ID
- COOLHEAD-2a / COOLHD24-CAN / A+10019
- Conditions
- Stroke, Acute
- Keywords
- Hypothermia, Large vessel occlusion, Neuroprotection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 28 Jul 2024 (actual)
- Primary completion
- 24 Nov 2024 (actual)
- Study completion
- 24 Feb 2025 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: External active conductive head coolingHead cooling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with anterior circulation acute ischemic stroke planned to undergo endovascular thrombectomy will be screened for recruitment.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External active conductive head coolingCooling is applied during the endovascular thrombectomy procedure for a maximum of 120 minutes | Device | Treatment arm |
Primary outcome
Adherence to the intervention
Time frame: From time of application in the emergency department until the end of the endovascular thrombectomy procedure
Adherence is defined as undergoing active conductive head cooling for ≥50% of the time from first application of the cooling device
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External active conductive head cooling in people with Stroke, Acute, run by University of Calgary at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the intervention (time frame: From time of application in the emergency department until the end of the endovascular thrombectomy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.