Targeted Temperature Management in Acute Ischemic Stroke

NCT07096687 | Recruiting

• 1 other identifier: TTM-STROKE
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional trial is to evaluate whether the CB240\_Aurora medical device is effective for targeted temperature management in adult patients with acute ischemic stroke. The main questions it aims to answer are: Is the CB240\_Aurora effective in maintaining normothermia in patients with acute ischemic stroke? Does the medical device improve clinical and radiological outcomes? Is the medical device well tolerated by patients? Researchers will compare an interventional arm, in which the CB240\_Aurora measures and treats body temperature to maintain normothermia, with a control arm, in which the CB240\_Aurora only measures but does not treat body temperature. Participants will wear the medical device for 72 consecutive hours in the Stroke Unit. Outcome assessments will be performed at 72 hours, 7 days, and 3 months.

Conditions

Ischemic Stroke

Keywords

ischemic stroke; neuroprotection; targeted temperature management

Outcome Measures

Primary Outcomes (1)

• Duration of normothermia maintenance during the first 72 hours

  Measure the duration (in hours) of maintained normothermia (between \>36°C and \<37°C) through axillary temperature monitoring during the first 72 hours.

  T0 (0 hour)T1; ( 72 hours)

Secondary Outcomes (7)

• Modified Rankin Scale (mRS)

  T2 (day 7); T3 (day 90)

• National Institutes of Health Stroke Scale (NIHSS)

  T2 (day 7); T3 (day 90)

• Change in the volume of the ischemic lesion measured by MRI

  T2 (day 7)

• hemorrhagic transformation of the ischemic lesion at MRI

  T2 (day 7)

• Incidence of adverse events (AEs) and severe AEs (SAEs) that are related to treatment.

  T0 (day 0); T1 (day 3); T2 (day 7); T3( day 90)

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Patients will receive targeted temperature management to maintain normothermia using the CB240\_Aurora device.

Device: Targeted Temperature Management with CB240_Aurora; Device: Standard of care Temperature treatment

Control Arm

SHAM COMPARATOR

CB240\_Aurora device used exclusively in temperature monitoring and control mode according to clinical standards

Device: Standard of care Temperature treatment

Interventions

Targeted Temperature Management with CB240_Aurora DEVICE

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.

Intervention Arm

Standard of care Temperature treatment DEVICE

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; Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years;
• 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.

You may not qualify if:

• Stroke involving multiple vascular territories;
• 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.

Sponsors & Collaborators

• Azienda Usl di Bologna: lead

Study Sites (1)

IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna

Bologna, Bologna, 40139, Italy

RECRUITING

Related Publications (19)

• 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.

  PMID: 37498461 BACKGROUND

• 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.

  PMID: 37225535 BACKGROUND

• 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.

  PMID: 34133859 BACKGROUND

• 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: 15086235 BACKGROUND

• 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.

  PMID: 27834742 BACKGROUND

• 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.

  PMID: 17904009 BACKGROUND

• 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.

  PMID: 36262833 BACKGROUND

• 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.

  PMID: 22353781 BACKGROUND

• 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.

  PMID: 20144981 BACKGROUND

• 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.

  PMID: 11856793 BACKGROUND

• 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.

  PMID: 11856794 BACKGROUND

• 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.

  PMID: 8618482 BACKGROUND

• 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.

  PMID: 29038971 BACKGROUND

• 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.

  PMID: 21670766 BACKGROUND

• 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.

  PMID: 29146878 BACKGROUND

• 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.

  PMID: 30188259 BACKGROUND

• 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.

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• Powers WJ. Acute Ischemic Stroke. N Engl J Med. 2020 Jul 16;383(3):252-260. doi: 10.1056/NEJMcp1917030. No abstract available.

  PMID: 32668115 BACKGROUND

• 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.

  PMID: 24449944 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cryotherapy; Therapeutics

Study Officials

• Andrea Zini

  IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Zini

CONTACT

+390516478810; a.zini@ausl.bologna.it

Stefano Forlivesi

CONTACT

+390516478889; stefano.forlivesi@ausl.bologna.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)