Medico-economic Evaluation of Preoperative Cerebral Oximetry Monitoring During Carotid Endarterectomy (EMOCAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Nantes University Hospital
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01415648
First received: July 11, 2011
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Internal Carotid Stenosis
Other: cerebral oximetry monitoring using INVOS™ and hemodynamic optimisation
Other: standard cerebral monitoring and hemodynamic optimisation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Medico-economic Evaluation of Preoperative Cerebral Oximetry Monitoring During Carotid Endarterectomy.

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • The number of new cerebral ischemic lesions [ Time Frame: Up to one month post-operative ] [ Designated as safety issue: No ]
    The number of new cerebral ischemic lesions observed on postoperative diffusion MRI


Secondary Outcome Measures:
  • Incremental cost-effectiveness ratio comparing the group monitored by cerebral oximeter and the standard care group [ Time Frame: 4 months post-operative ] [ Designated as safety issue: No ]
  • Hospitalization length of stay and direct medical costs [ Time Frame: 4 months post-operative ] [ Designated as safety issue: No ]
  • Neurologic and neurocognitive postoperative disorders [ Time Frame: 1 month post-operative ] [ Designated as safety issue: No ]
  • Postoperative quality of life (SF36, EQ5D tests) [ Time Frame: 4 months post-operative ] [ Designated as safety issue: No ]
  • Cerebral desaturation threshold assessment [ Time Frame: 4 months post-operative ] [ Designated as safety issue: No ]

Estimated Enrollment: 978
Study Start Date: April 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: open NIRS
continuous per operative cerebral oximetry monitoring (using INVOS™ cerebral oximeter) associated with hemodynamic optimisation algorithm (excluding norepinephrine) if cerebral oximetry decrease more than 15% under the preoperative baseline
Other: cerebral oximetry monitoring using INVOS™ and hemodynamic optimisation
continuous per operative cerebral oximetry monitoring associated with hemodynamic optimisation algorithm (excluding norepinephrine) if cerebral oximetry decrease more than 15% under the preoperative baseline
Other Name: INVOS™
Sham Comparator: Blinded NIRS
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
Other: standard cerebral monitoring and hemodynamic optimisation
the patient is continously 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415648

Contacts
Contact: Yann Le Teurnier, MD +33 2 40 16 53 04 yann.leteurnier@chu-nantes.fr
Contact: Bertrand Rozec, MD +33 2 40 16 53 08 bertrand.rozec@chu-nantes.fr

Locations
France
Besancon University Hospital "Hôpital Jean Minjoz" Completed
Besancon, France
Bordeaux University Hospital "Hôpital Pellegrin" Completed
Bordeaux, France
Bordeaux University Hospital "Haut Lévêque" Completed
Bordeaux, France
Brest University Hospital "La Cavale Blanche" Completed
Brest, France
Caen University Hospital "Côte de Nacre" Completed
Caen, France
Dijon University Hospital "Le Bocage" Completed
Dijon, France
Le Mans Hospital Completed
Le Mans, France
Hospital de Marie Lannelongue Plessis Robinson Completed
Le Plessis Robinson, France
Lyon University Hospital "Hôpital Edouard Herriot" Completed
Lyon, France
Marseille University Hospital "Hôpital de la Timone" Completed
Marseille, France
"Nouvelles Cliniques Nantaises" Completed
Nantes, France
Nantes University Hospital Recruiting
Nantes, France, 44000
Contact: Yann Le Teurnier, MD    +33 2 40 16 53 04    yann.leteurnier@chu-nantes.fr   
Contact: Bertrand Rozec, MD    +33 2 40 16 53 08    bertrand.rozec@chu-nantes.fr   
Principal Investigator: Yann Le Teurnier, MD         
Sub-Investigator: Bertrand Rozec, MD         
Nice University Hospital "Saint-Roch" Completed
Nice, France
"Groupe Hospitalier Saint-Joseph" Completed
Paris, France
"Hôpital Européen Georges Pompidou" Completed
Paris, France
Reims University Hospital "Robert Debré" Completed
Reims, France
Rennes University Hospital "Pontchaillou" Completed
Rennes, France
Strasbourg University Hospital Completed
Strasbourg, France
Toulouse University Hospital Completed
Toulouse, France
Sponsors and Collaborators
Nantes University Hospital
Ministry of Health, France
Investigators
Principal Investigator: Yann Le Teurnier, MD CHU Nantes
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01415648     History of Changes
Other Study ID Numbers: STIC/10/02, 2010-A01167-32
Study First Received: July 11, 2011
Last Updated: September 26, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
with surgical indication
Cerebral oximetry
carotid endarterectomy
MRI
ischemic lesion
cost/effectiveness analysis
Neurocognitive Outcome
protein S-100B

Additional relevant MeSH terms:
Carotid Stenosis
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014