Targeted Temperature Management in Acute Ischemic Stroke
NCT ID: NCT07096687
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
22 participants
INTERVENTIONAL
2025-09-11
2027-03-31
Brief Summary
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Detailed Description
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In this context, Neuron Guard has developed the CB240\_Aurora device, which targets cerebral temperature through the vascular anatomy of the neck to enhance heat exchange. This system has shown potential in stabilizing brain temperature while maintaining systemic normothermia and reducing systemic side effects. Its use could be extended beyond intensive care settings to broader patient populations, both for managing fever episodes and for enhancing neuroprotection.
The experimental treatment with the CB240\_Aurora device is designed as a complementary approach to standard therapies, aiming to improve their effectiveness. The device will continuously monitor body temperature and deliver treatment to maintain normothermia, defined as a temperature ≥36°C and \<37°C at the time of study inclusion.
In the control group, patients will receive care according to the latest ischemic stroke treatment guidelines, including standard temperature management. In this group, the CB240\_Aurora device will be used exclusively for temperature monitoring without providing active treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intervention Arm
Patients will receive targeted temperature management to maintain normothermia using the CB240\_Aurora device.
Targeted Temperature Management with CB240_Aurora
The proposed experimental treatment with the CB240\_Aurora device will serve as a complementary approach to standard therapies, aiming to enhance their effectiveness. The device will continuously monitor body temperature and deliver treatment to maintain normothermia, defined as a temperature ≥36°C and \<37°C at the time of study inclusion.
Standard of care Temperature treatment
In the control group, patients will receive treatment according to the latest guidelines for the management of ischemic stroke, including standard body temperature management. The CB240\_Aurora device will be used exclusively in monitoring mode, without delivering any active treatment, and will be maintained for 72 consecutive hours from the time of enrollment
Control Arm
CB240\_Aurora device used exclusively in temperature monitoring and control mode according to clinical standards
Standard of care Temperature treatment
In the control group, patients will receive treatment according to the latest guidelines for the management of ischemic stroke, including standard body temperature management. The CB240\_Aurora device will be used exclusively in monitoring mode, without delivering any active treatment, and will be maintained for 72 consecutive hours from the time of enrollment
Interventions
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Targeted Temperature Management with CB240_Aurora
The proposed experimental treatment with the CB240\_Aurora device will serve as a complementary approach to standard therapies, aiming to enhance their effectiveness. The device will continuously monitor body temperature and deliver treatment to maintain normothermia, defined as a temperature ≥36°C and \<37°C at the time of study inclusion.
Standard of care Temperature treatment
In the control group, patients will receive treatment according to the latest guidelines for the management of ischemic stroke, including standard body temperature management. The CB240\_Aurora device will be used exclusively in monitoring mode, without delivering any active treatment, and will be maintained for 72 consecutive hours from the time of enrollment
Eligibility Criteria
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Inclusion Criteria
* Both sexes;
* Diagnosis of acute ischemic stroke confirmed by clinical evaluation by a neurologist and neuroimaging (CT or brain MRI);
* Acute ischemic stroke with symptom onset within 48 hours;
* Anterior circulation stroke with evidence on neuroimaging (CT angiography) of occlusion of the middle cerebral artery in segments M1, M2, or M3;
* NIHSS score between 6 and 25;
* First clinical stroke;
* Axillary temperature ≥36°C and \<37°C;
* Informed consent obtained for study participation.
Exclusion Criteria
* Presence of intracerebral hemorrhage;
* Pregnancy;
* Moderate-to-severe or severe pre-stroke disability defined as mRS \>3;
* Presence of a cardiac pacemaker or any other conditions contraindicating brain MRI.
18 Years
ALL
No
Sponsors
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Azienda Usl di Bologna
OTHER_GOV
Responsible Party
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Principal Investigators
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Andrea Zini
Role: PRINCIPAL_INVESTIGATOR
IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna
Locations
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IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna
Bologna, Bologna, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Lavinio A, Beqiri E, Kataria K. A Novel Technology for Targeted Brain Temperature Management. Neurocrit Care. 2024 Apr;40(2):785-790. doi: 10.1007/s12028-023-01800-7. Epub 2023 Jul 27. No abstract available.
Lavinio A, Andrzejowski J, Antonopoulou I, Coles J, Geoghegan P, Gibson K, Gudibande S, Lopez-Soto C, Mullhi R, Nair P, Pauliah VP, Quinn A, Rasulo F, Ratcliffe A, Reddy U, Rhodes J, Robba C, Wiles M, Williams A. Targeted temperature management in patients with intracerebral haemorrhage, subarachnoid haemorrhage, or acute ischaemic stroke: updated consensus guideline recommendations by the Neuroprotective Therapy Consensus Review (NTCR) group. Br J Anaesth. 2023 Aug;131(2):294-301. doi: 10.1016/j.bja.2023.04.030. Epub 2023 May 22.
Dankiewicz J, Cronberg T, Lilja G, Jakobsen JC, Levin H, Ullen S, Rylander C, Wise MP, Oddo M, Cariou A, Belohlavek J, Hovdenes J, Saxena M, Kirkegaard H, Young PJ, Pelosi P, Storm C, Taccone FS, Joannidis M, Callaway C, Eastwood GM, Morgan MPG, Nordberg P, Erlinge D, Nichol AD, Chew MS, Hollenberg J, Thomas M, Bewley J, Sweet K, Grejs AM, Christensen S, Haenggi M, Levis A, Lundin A, During J, Schmidbauer S, Keeble TR, Karamasis GV, Schrag C, Faessler E, Smid O, Otahal M, Maggiorini M, Wendel Garcia PD, Jaubert P, Cole JM, Solar M, Borgquist O, Leithner C, Abed-Maillard S, Navarra L, Annborn M, Unden J, Brunetti I, Awad A, McGuigan P, Bjorkholt Olsen R, Cassina T, Vignon P, Langeland H, Lange T, Friberg H, Nielsen N; TTM2 Trial Investigators. Hypothermia versus Normothermia after Out-of-Hospital Cardiac Arrest. N Engl J Med. 2021 Jun 17;384(24):2283-2294. doi: 10.1056/NEJMoa2100591.
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.
Lyden P, Hemmen T, Grotta J, Rapp K, Ernstrom K, Rzesiewicz T, Parker S, Concha M, Hussain S, Agarwal S, Meyer B, Jurf J, Altafullah I, Raman R; Collaborators. Results of the ICTuS 2 Trial (Intravascular Cooling in the Treatment of Stroke 2). Stroke. 2016 Dec;47(12):2888-2895. doi: 10.1161/STROKEAHA.116.014200. Epub 2016 Nov 10.
Lyden PD, Allgren RL, Ng K, Akins P, Meyer B, Al-Sanani F, Lutsep H, Dobak J, Matsubara BS, Zivin J. Intravascular Cooling in the Treatment of Stroke (ICTuS): early clinical experience. J Stroke Cerebrovasc Dis. 2005 May-Jun;14(3):107-14. doi: 10.1016/j.jstrokecerebrovasdis.2005.01.001.
You JS, Kim JY, Yenari MA. Therapeutic hypothermia for stroke: Unique challenges at the bedside. Front Neurol. 2022 Oct 3;13:951586. doi: 10.3389/fneur.2022.951586. eCollection 2022.
Yenari MA, Han HS. Neuroprotective mechanisms of hypothermia in brain ischaemia. Nat Rev Neurosci. 2012 Feb 22;13(4):267-78. doi: 10.1038/nrn3174.
Edwards AD, Brocklehurst P, Gunn AJ, Halliday H, Juszczak E, Levene M, Strohm B, Thoresen M, Whitelaw A, Azzopardi D. Neurological outcomes at 18 months of age after moderate hypothermia for perinatal hypoxic ischaemic encephalopathy: synthesis and meta-analysis of trial data. BMJ. 2010 Feb 9;340:c363. doi: 10.1136/bmj.c363.
Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. doi: 10.1056/NEJMoa012689.
Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63. doi: 10.1056/NEJMoa003289.
Reith J, Jorgensen HS, Pedersen PM, Nakayama H, Raaschou HO, Jeppesen LL, Olsen TS. Body temperature in acute stroke: relation to stroke severity, infarct size, mortality, and outcome. Lancet. 1996 Feb 17;347(8999):422-5. doi: 10.1016/s0140-6736(96)90008-2.
Madden LK, Hill M, May TL, Human T, Guanci MM, Jacobi J, Moreda MV, Badjatia N. The Implementation of Targeted Temperature Management: An Evidence-Based Guideline from the Neurocritical Care Society. Neurocrit Care. 2017 Dec;27(3):468-487. doi: 10.1007/s12028-017-0469-5.
Donnan GA, Davis SM, Parsons MW, Ma H, Dewey HM, Howells DW. How to make better use of thrombolytic therapy in acute ischemic stroke. Nat Rev Neurol. 2011 Jun 14;7(7):400-9. doi: 10.1038/nrneurol.2011.89.
Savitz SI, Baron JC, Yenari MA, Sanossian N, Fisher M. Reconsidering Neuroprotection in the Reperfusion Era. Stroke. 2017 Dec;48(12):3413-3419. doi: 10.1161/STROKEAHA.117.017283. Epub 2017 Nov 16. No abstract available.
Rabinstein AA, Albers GW, Brinjikji W, Koch S. Factors that may contribute to poor outcome despite good reperfusion after acute endovascular stroke therapy. Int J Stroke. 2019 Jan;14(1):23-31. doi: 10.1177/1747493018799979. Epub 2018 Sep 6.
Vanacker P, Lambrou D, Eskandari A, Mosimann PJ, Maghraoui A, Michel P. Eligibility and Predictors for Acute Revascularization Procedures in a Stroke Center. Stroke. 2016 Jul;47(7):1844-9. doi: 10.1161/STROKEAHA.115.012577. Epub 2016 Jun 14.
Powers WJ. Acute Ischemic Stroke. N Engl J Med. 2020 Jul 16;383(3):252-260. doi: 10.1056/NEJMcp1917030. No abstract available.
Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson L, Truelsen T, O'Donnell M, Venketasubramanian N, Barker-Collo S, Lawes CM, Wang W, Shinohara Y, Witt E, Ezzati M, Naghavi M, Murray C; Global Burden of Diseases, Injuries, and Risk Factors Study 2010 (GBD 2010) and the GBD Stroke Experts Group. Global and regional burden of stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014 Jan 18;383(9913):245-54. doi: 10.1016/s0140-6736(13)61953-4.
Other Identifiers
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TTM-STROKE
Identifier Type: -
Identifier Source: org_study_id
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