- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02176993
Effects of Surface Cooling On Stroke Outcome triaL (COOL) (COOL)
Effects of Surface Cooling On Stroke Outcome triaL: a Feasibility and Safety Study
The investigators goal is to improve the outcome of patients with acute stroke by inducing mild cerebral hypothermia through surface cooling at the cervical and shoulder regions using EMCOOLS Brain.Pads®.
For this project, the investigators can build further on their research group's experience with hypothermia in animal models and invasive cooling in stroke patients.
The COOL program will prospectively evaluate safety, feasibility, patient acceptance and efficacy of mild cerebral hypothermia using EMCOOLS Brain.Pads® in a large cohort of patients presenting with acute stroke at the Emergency Department of the Universitair Ziekenhuis Brussel. The application of EMCOOLS Brain.Pads® will be compared to routine clinical practice in a randomized controlled trial. If proven to be safe, feasible, well-tolerated and efficacious in the inhospital setting, future use in prehospital acute stroke care will be incorporated with telemedicine support, as part of the Prehospital Stroke Study at the Universitair ziekenhuis Brussel (PreSSUB).
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Several studies have identified fever as an independent predictor of poor outcome in patients with acute stroke. Experimental data and clinical studies indicate that therapeutic hypothermia has neuroprotective effects associated with better clinical outcome, probably through reduction of infarct volume and cerebral edema in patients with ischemic and hemorrhagic stroke, respectively. It is to be expected that the beneficiary effects of hypothermia will be more pronounced if initiated early after stroke onset, which underlines the rational that this technique ideally should be initiated in the prehospital phase of acute stroke management.
Therapeutic hypothermia can be obtained by external or by endovascular cooling. Most methods aim to lower the body temperature to <33°C and therefore require patient sedation and intubation. In contrast to patients with cardiac arrest, sedation and intubation preferably are avoided and profound cooling of the entire body is not desired nor required in in stroke patients. EMCOOLS pads® have originally been developed by EMCOOLS Medical Cooling Systems AG (Austria) for profound external cooling of patients with cardiac arrest. The novel EMCOOLS Brain.Pad® was redesigned to mildly lower the brain temperature through noninvasive surface cooling of the cerebropetal arteries at the cervical level. Pilot studies in healthy volunteers demonstrated that a decrease of 0.5-1°C (tympanic measurement) can be safely obtained by application of EMCOOLS Brain.Pad® during 60 to 90 minutes. No relevant side effects were observed in these small studies, but possible effects on cerebrovascular blood flow were not evaluated.
Early application of mild therapeutic hypothermia in acute stroke patients builds further on their research group's experience with hypothermia in animal models and stroke patients. The investigators propose a prospective clinical trial comparing current clinical practice with the induction of mild hypothermia using EMCOOLS Brain.Pads® in patients presenting with acute stroke. If safety, feasibility, patient acceptance and efficacy are confirmed in the inhospital setting, the next step will involve evaluation of this approach in prehospital acute stroke care.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Brussels, Belgio, 1090
- Universitair Ziekenhuis Brussel
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Older than 18 years
- Acute stroke with onset < 24 hours
Exclusion Criteria:
- Pregnancy
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
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Application of surface cooling
Surface cooling during 60 minutes.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Improvement of neurological deficit as measured by NIHSS
Lasso di tempo: 90 days post-stroke
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The National Institute of Health Stroke Scale (NIHSS) will be used as a measure to assess the gain in neurological deficit 90 days post-stroke.
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90 days post-stroke
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Temperature change during surface cooling
Lasso di tempo: During cooling and 30 minutes thereafter
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Changes in temperature will be measured with mastoid, inguinal, tympanic and temporal thermometers.
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During cooling and 30 minutes thereafter
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Long-term functional outcome
Lasso di tempo: 3 months post-stroke
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The functional outcome will be measured by the modified Rankin Scale (mRS).
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3 months post-stroke
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Mortality rate
Lasso di tempo: 3 months post-stroke
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3 months post-stroke
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Robbert-Jan van Hooff, M.D., Ph.D., Universitair Ziekenhuis Brussel Belgium
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- B.U.N. 143201215226
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .