NCT07526649

Brief Summary

COOLHEAD-2b is a multicentre, phase 2, prospective, randomised, controlled, open-label, blinded-endpoint trial evaluating the safety and efficacy of non-invasive convective head cooling as an adjunct to endovascular thrombectomy (EVT) in patients with acute anterior circulation ischaemic stroke. Head cooling is initiated as early as possible, including during inter-hospital transfer, and continued until one hour after reperfusion. The primary efficacy endpoint is final infarct volume at 24 hours.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable stroke

Timeline
39mo left

Started Apr 2026

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Jun 2029

First Submitted

Initial submission to the registry

March 29, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

April 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

March 29, 2026

Last Update Submit

April 9, 2026

Conditions

Reperfusion InjuryLarge Vessel OcclusionStrokeAcute Ischemic StrokeBrain IschemiaIschaemic StrokeThrombectomyEndovascular ProceduresCooling

Keywords

Head coolingSelective brain coolingEndovascular thrombectomyTherapeutic hypothermiaPenumbraNeuroprotection

Outcome Measures

Primary Outcomes (1)

  • Final Infarct Volume

    Final infarct volume (mL), defined as the manually segmented volume of infarcted brain tissue on 24-hour follow-up CT or MRI brain imaging. Segmentation will be performed by a blinded imaging core laboratory using de-identified imaging files.

    24 hours after endovascular thrombectomy

Secondary Outcomes (7)

  • Infarct growth

    Baseline imaging to 24 hours after endovascular thrombectomy

  • Penumbral salvage index

    Baseline imaging to 24 hours after endovascular thrombectomy

  • Early neurological improvement

    Baseline to 24 hours after endovascular thrombectomy

  • Modified Rankin Scale (mRS) score

    90 days after endovascular thrombectomy

  • Proportion of Participants with Functional Independence

    90 days after endovascular thrombectomy

  • +2 more secondary outcomes

Other Outcomes (9)

  • All cause mortality

    90 days after endovascular thrombectomy

  • Number of Participants with Symptomatic Intracranial Haemorrhage

    Within 36 hours after endovascular thrombectomy

  • Number of Participants with New Arrhythmia and Haemodynamic Compromise

    During the head cooling intervention period, from initiation of cooling to one hour after reperfusion.

  • +6 more other outcomes

Study Arms (2)

Non-invasive Convective Head Cooling + Standard of Care

EXPERIMENTAL

Participants receive non-invasive convective head cooling in addition to standard clinical care for acute anterior circulation ischaemic stroke undergoing endovascular thrombectomy. Head cooling is initiated as early as possible following randomisation and continued throughout interhospital transfer (if applicable), endovascular thrombectomy, and for one hour after reperfusion.

Device: Non-invasive convective head cooling

Standard of Care (SOC) Alone

ACTIVE COMPARATOR

Participants receive standard clinical care for acute anterior circulation ischaemic stroke undergoing endovascular thrombectomy, without head cooling.

Other: Standard of Care (SOC)

Interventions

Non-invasive convective head coolingDEVICE

Non-invasive convective head cooling delivered using a cooling cap system that circulates chilled fluid around the scalp and neck. Cooling is commenced in the emergency department following randomisation, with a target coolant temperature of -5 °C (adjustable for comfort). Cooling is continued during interhospital transfer (if applicable), during the endovascular thrombectomy procedure, and for one hour following reperfusion. Systemic rewarming measures may be used to maintain core body temperature above 35 °C if required.

Non-invasive Convective Head Cooling + Standard of Care
Standard of Care (SOC)OTHER

Guideline-based management of acute ischaemic stroke, including endovascular thrombectomy, with supportive medical care as determined by the treating clinical team. No head cooling device is applied.

Standard of Care (SOC) Alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute anterior circulation ischaemic stroke planned for endovascular thrombectomy
  • Age ≥18 years

You may not qualify if:

  • Pre-stroke modified Rankin Scale score \>2
  • Core body temperature \<35°C at admission
  • Uncontrolled hypertension (≥185/110 mmHg despite treatment in IVT-eligible patients)
  • Known contraindications to hypothermia (e.g., haemodynamic instability, symptomatic bradyarrhythmia, cryoglobulinaemia, sickle cell disease, cold agglutinins)
  • Vasospastic disorders (e.g., Raynaud's phenomenon)
  • Skin lesions preventing secure application of the cooling cap
  • Inability to participate in 90-day follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health New Zealand - Auckland

Grafton, Auckland, 1023, New Zealand

Location

Related Publications (7)

  • Rinkel LA, Ospel JM, Brown SB, Campbell BCV, Dippel DWJ, Demchuk AM, Majoie CBLM, Mitchell PJ, Bracard S, Guillemin F, Jovin TG, Muir KW, White P, Saver JL, Hill MD, Goyal M; HERMES Collaborators. What Is a Meaningful Difference When Using Infarct Volume as the Primary Outcome?: Results From the HERMES Database. Stroke. 2024 Apr;55(4):866-873. doi: 10.1161/STROKEAHA.123.044353. Epub 2024 Mar 5.

    PMID: 38440891BACKGROUND

  • Jabonero V, Martinez R, Marin Giron F, Jabonero RM. [Studies on synapses of the peripheral vegetative nervous system. V. Additional observations on the ending systems of postganglionic nerve fibers]. Z Mikrosk Anat Forsch. 1965;73(1):96-116. No abstract available. German.

    PMID: 4161451BACKGROUND

  • Wang H, Olivero W, Lanzino G, Elkins W, Rose J, Honings D, Rodde M, Burnham J, Wang D. Rapid and selective cerebral hypothermia achieved using a cooling helmet. J Neurosurg. 2004 Feb;100(2):272-7. doi: 10.3171/jns.2004.100.2.0272.

    PMID: 15086235BACKGROUND

  • Diprose WK, Wang MTM, Campbell D, Sutcliffe JA, McFetridge A, Chiou D, Lai J, Barber PA. Intravenous Propofol Versus Volatile Anesthetics For Stroke Endovascular Thrombectomy. J Neurosurg Anesthesiol. 2021 Jan;33(1):39-43. doi: 10.1097/ANA.0000000000000639.

    PMID: 31453877BACKGROUND

  • Svensson B. [The prevalence of rheumatoid arthritis is lower than previously known]. Lakartidningen. 1989 Jan 4;86(1-2):45-6. No abstract available. Swedish.

    PMID: 2783474BACKGROUND

  • van der Worp HB, Sena ES, Donnan GA, Howells DW, Macleod MR. Hypothermia in animal models of acute ischaemic stroke: a systematic review and meta-analysis. Brain. 2007 Dec;130(Pt 12):3063-74. doi: 10.1093/brain/awm083. Epub 2007 May 3.

    PMID: 17478443BACKGROUND

  • Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18.

    PMID: 26898852BACKGROUND

MeSH Terms

Conditions

StrokeIschemic StrokeBrain IschemiaReperfusion Injury

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • William Diprose, MBChB

    University of Auckland, New Zealand

    PRINCIPAL INVESTIGATOR

  • Alan Barber, PhD

    University of Auckland, New Zealand

    PRINCIPAL INVESTIGATOR

  • Doug Campbell, MBChB

    Auckland City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Davina J McAllister, DipNursing

CONTACT

+64274891940davina.mcallister@tewhatuora.govt.nz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is a randomized, controlled trial evaluating a non-pharmacological device intervention (non-invasive convective head cooling) as an adjunct to standard endovascular thrombectomy care."
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2026

First Posted

April 13, 2026

Study Start

April 10, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

June 30, 2029

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared outside the study team. This trial involves detailed clinical, imaging, and procedural data collected within a relatively small and geographically defined population, which increases the risk of participant re-identification despite de-identification. In addition, no consent for broader data sharing beyond the study investigators was obtained from participants or their representatives. Access to the final dataset will therefore be restricted to the study investigators for the purposes of scientific analysis and publication.

Locations

NZ(1)