Clinical trial NCT01415648: Medico-economic Evaluation of Preoperative Cerebral Oximetry Monitoring During Carotid Endarterectomy
Official title: Medico-economic Evaluation of Preoperative Cerebral Oximetry Monitoring During Carotid Endarterectomy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Internal Carotid Stenosis
Keywords: with surgical indication
Cerebral oximetry
carotid endarterectomy
MRI
ischemic lesion
cost/effectiveness analysis
Neurocognitive Outcome
protein S-100B
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2011-08-12
Enrollment: 879
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 concerning the best cerebral monitoring and hemodynamic optimisation during carotid cross-clamping.

The objective of this prospective, multicentric, double-blinded and randomized study is to evaluate the interest of continuous cerebral oximetry monitoring by INVOS™ cerebral oximeter to direct the hemodynamic optimisation during carotid endarterectomy and reduce the new-onset of postoperative radiological (MRI) ischemic lesions. A cost/effectiveness analysis will be conducted to estimate the impact of this monitoring versus standard care on direct and indirect postoperative costs during 120 days.

A substudy will evaluate the effect of this monitoring on neurocognitive outcome and on a serum marker of brain injury, protein S-100B

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 norepinephrine) if cerebral oximetry decrease more than 15% under the preoperative baseline; the second group is continuously monitored with cerebral oximeter but this latter is blinded to the medical team, the alarm switch off , and patients are managed with the standard care of the centre.

All patients have a preoperative and a postoperative diffusion cerebral MRI to detect new onset of cerebral ischemic lesion. The amount and the volume of cerebral ischemic lesions will be scored to compare groups.

Quality of life as well as direct (medical and nonmedical) and indirect costs were collected using questionnaires during the 120 postoperative days.

A substudy including 200 patients will be conducted to compare the two groups concerning postoperative protein S-100B level and a composite score of neurocognitive tests (measured pre- and postoperatively) The trial will be conducted according to GCP

Eligibility criteria: Inclusion Criteria:

* Patients (male-female) over 18 y.o.
* Presenting an internal carotid stenosis requiring surgery
* Mini Mental State Examination \>24 during preoperative examination
* Informed written consentExclusion Criteria:

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

Primary outcomes:
measure: The number of new cerebral ischemic lesions
timeFrame: Up to 3 days post-operative
Secondary outcomes:
measure: Incremental cost-effectiveness ratio comparing the group monitored by cerebral oximeter and the standard care group
timeFrame: 4 months post-operative
measure: Hospitalization length of stay
timeFrame: 4 months post-operative
measure: Percentage of patient with Neurologic and neurocognitive postoperative disorders
timeFrame: 4 months post-operative
measure: Percentage of patient with Cardiovascular postoperative disorders
timeFrame: 4 months post-operative
measure: Percentage of patient with Surgical events
timeFrame: 4 months post-operative
measure: Postoperative quality of life (SF36, EQ5D tests)
timeFrame: 4 months post-operative
measure: Incidence of death 4 month postoperatively
timeFrame: 4 months post-operative
Other outcomes:
Locations:
city: Besancon
country: France
facility: Besancon University Hospital "Hôpital Jean Minjoz"
city: Bordeaux
country: France
facility: Bordeaux University Hospital "Haut Lévêque"
city: Bordeaux
country: France
facility: Bordeaux University Hospital "Hôpital Pellegrin"
city: Brest
country: France
facility: Brest University Hospital "La Cavale Blanche"
city: Caen
country: France
facility: Caen University Hospital "Côte de Nacre"
city: Dijon
country: France
facility: Dijon University Hospital "Le Bocage"
city: Le Mans
country: France
facility: Le Mans Hospital
city: Le Plessis Robinson
country: France
facility: Hospital de Marie Lannelongue Plessis Robinson
city: Lyon
country: France
facility: Lyon University Hospital "Hôpital Edouard Herriot"
city: Marseille
country: France
facility: Marseille University Hospital "Hôpital de la Timone"
city: Nantes
country: France
facility: Nantes University Hospital
city: Nantes
country: France
facility: "Nouvelles Cliniques Nantaises"
city: Nice
country: France
facility: Nice University Hospital "Saint-Roch"
city: Paris
country: France
facility: "Groupe Hospitalier Saint-Joseph"
city: Paris
country: France
facility: "Hôpital Européen Georges Pompidou"
city: Reims
country: France
facility: Reims University Hospital "Robert Debré"
city: Rennes
country: France
facility: Rennes University Hospital "Pontchaillou"
city: Strasbourg
country: France
facility: Strasbourg University Hospital
city: Toulouse
country: France
facility: Toulouse University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Yann Le Teurnier, MD
role: PRINCIPAL_INVESTIGATOR
References: