Status:
TERMINATED
Medico-economic Evaluation of Preoperative Cerebral Oximetry Monitoring During Carotid Endarterectomy
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Internal Carotid Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In France, in 2007, 17 000 patients underwent carotid endarterectomy. The risk of having an ipsilateral postoperative stroke after carotid endarterectomy remains at 1-1.5%. There is no consensus conce...
Detailed Description
After consent, patients will be randomized in two groups: one group with continuous per operative cerebral oximetry monitoring associated with hemodynamic optimisation algorithm (excluding norepinephr...
Eligibility Criteria
Inclusion
- Patients (male-female) over 18 y.o.
- Presenting an internal carotid stenosis requiring surgery
- Mini Mental State Examination \>24 during preoperative examination
- Informed written consent
Exclusion
- Exclusion criteria:
- Severe renal failure or requiring dialysis
- Liver failure or cirrhosis (Child class ≥ B) or prothrombin activity\<50%
- Heart failure (NYHA ≥ III), left ventricular ejection fraction \< 40%, acute coronary syndrome,
- Associated surgery
- Pregnancy
- Contraindication to MRI
- History of allergy to modified gelatine or starch
- History of allergy to adhesive part of electrode
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
879 Patients enrolled
Trial Details
Trial ID
NCT01415648
Start Date
April 1 2011
End Date
April 1 2016
Last Update
November 29 2023
Active Locations (19)
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1
Besancon University Hospital "Hôpital Jean Minjoz"
Besançon, France
2
Bordeaux University Hospital "Haut Lévêque"
Bordeaux, France
3
Bordeaux University Hospital "Hôpital Pellegrin"
Bordeaux, France
4
Brest University Hospital "La Cavale Blanche"
Brest, France