Clinical trial NCT02629653: Body Cooling During Carotid Endarterectomy: No-profit, Open, Mono-centric, Feasibility Study
Official title: Body Cooling During Carotid Endarterectomy: No-profit, Open, Mono-centric, Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Artery Diseases
Hypothermia
Stroke
Carotid Artery Plaque
Carotid Artery Stenosis
Cerebrovascular Accident
Keywords: carotid endarterectomy
stroke
hypothermia
endovascular cooling
Lead sponsor: S. Andrea Hospital
Sponsor class: OTHER
First posted: 2015-12-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: The study is based on the hypothesis that performing CEA during hypothermia substantially reduces the risk due to a potential, temporary hypoperfusion, associated with the surgical procedure.

The rationale behind the study is based on the assumption that Carotid EndArterectomy (CEA), by removing local causes of downstream altered circulation, improves cerebral hemodynamics and provides an effective prevention of stroke and TIA. The intervention itself, however, causes immediate risk of stroke or death, and it is also an issue whether the temporary reduction of blood flow associated with clamping of the artery, during the surgical intervention, may trigger long-lasting brain tissue dysfunction.

Mild hypothermia (34-35 °C) is probably the most effective approach to protect the brain from ischemic insults. Most of the supportive data were obtained in animal models of ischemia. Several phase II trials have shown safety and feasibility of cooling subjects with stroke, in the hours following onset of symptoms. Early interventions show the highest benefit.

Eligible patients will initiate cooling 60-90 min before CEA with endovascular cooling (Zoll system) to the target 34-35°C (assessed by bladder thermometer). The Zoll IVTM system is an endovascular cooling system that consists of a control module (either CoolGard 3000 or Thermogard XP), a CoolGard start-up kit, an ICY catheter (either IC-3585 AE or IC-3585 CO or IC-3893 AE or IC-3893 CO), a catheter convenience kit for catheter insertion (CO models only), thermal probes and cables. All the devise component have CE mark. The Low temperature will be maintained during the CEA procedure, followed by gradual, passive, controlled rewarming (0.4 °C/h). Type of anaesthesia will be decided according to good clinical practice. The cooling procedure will be, therefore, carried out during the anaesthesia procedure required by the surgical intervention. There is a chance that the duration of the anaesthesia will be longer that required, but all the efforts will be undertaken to keep the anaesthesia time as short as if there were no cooling

Clinical and instrumental evaluations will be carried out before and post intervention. Each evaluation will consist of physical examination, neuropsychological evaluation (MoCA test), blood tests and brain MRI or TC.

Safety is evaluated on the basis of severe adverse event

Eligibility criteria: Inclusion Criteria:

1. Subject eligible for CEA, without progression of symptoms, with low (\<4) Anesthesia Risk Assessment
2. Age ≥ 18 years;
3. Written informed consent

Exclusion Criteria:

1. 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;
2. Progression or instability of neurological status
3. 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;
4. Blood oxygen saturation below 94%, allowing a maximum of 2 L/min oxygen delivered nasally to achieve this;
5. Bradycardia (\<40 beats/min);
6. Body weight \> 120 kg;
7. Severe hepatic dysfunction, or severe renal dysfunction;
8. Pregnancy. Women of childbearing potential are excluded unless a negative test for pregnancy has been obtained prior to randomisation;
9. Other serious illness that may confound treatment assessment or increase the risks of cooling;
10. Social or other conditions that according to the investigator's judgement might be a major problem for follow-up.

Primary outcomes:
measure: Adverse events
timeFrame: Any adverse event at 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: NESMOS Department St. Andrea Hospital
Study officials:
affiliation: NESMOS Department, University of Rome "La Sapienza"; St. Andrea Hospital
name: Francesco Orzi, Prof, MD
role: STUDY_CHAIR
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citation: Candela S, Dito R, Casolla B, Silvestri E, Sette G, Filippi F, Taurino M, Brancadoro D, Orzi F. Hypothermia during Carotid Endarterectomy: A Safety Study. PLoS One. 2016 Apr 8;11(4):e0152658. doi: 10.1371/journal.pone.0152658. eCollection 2016.