Aim of the study is to determine whether endovascular systemic cooling to a target
temperature of 34-35°C initiated before, and maintained during Carotid EndoArterectomy (CEA),
is feasible and safe
Device: endovascular cooling (Zoll system)
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Locations near you
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Full eligibility criteria for NCT02629653
Ages eligible for Study
18 Years to 80 Years
Genders eligible for Study
Accepts Healthy Volunteers
Subject eligible for CEA, without progression of symptoms, with low (<4) Anesthesia Risk Assessment
Age ≥ 18 years;
Written informed consent
Evidence from a CT or MRI scan or from other pre-inclusion investigations of an intracranial haemorrhage, a tumour, encephalitis, or any diagnosis of acute brain focal lesion;
Progression or instability of neurological status
Conditions that may be exacerbated by hypothermia, such as haematological dyscrasias, oral anticoagulant treatment with INR ≥ 1.7, severe pulmonary disease, severe heart failure (defined as a New York Heart Association (NYHA) score of III or IV), history of myocardial infarction within the previous 3 months, angina pectoris in the previous 3 months, severe infection with a C-reactive protein > 50 mg/dl, or a clinical diagnosis of sepsis;
Blood oxygen saturation below 94%, allowing a maximum of 2 L/min oxygen delivered nasally to achieve this;
Bradycardia (<40 beats/min);
Body weight > 120 kg;
Severe hepatic dysfunction, or severe renal dysfunction;
Pregnancy. Women of childbearing potential are excluded unless a negative test for pregnancy has been obtained prior to randomisation;
Other serious illness that may confound treatment assessment or increase the risks of cooling;
Social or other conditions that according to the investigator's judgement might be a major problem for follow-up.
All locations for NCT02629653
NESMOS Department St. Andrea Hospital
Rome, Italy, 00189
View full eligibility
Tris trial is registered with FDA with number: NCT02629653. The sponsor of the trial is S. Andrea Hospital and it is looking for 10 volunteers for the current phase.
Official trial title: Body Cooling During Carotid Endarterectomy: No-profit, Open, Mono-centric, Feasibility Study
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