Flow Cytometry Applied to the Diagnosis of Peri-anaesthesic Reactions (CYPREANE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01305161
Recruitment Status : Unknown
Verified August 2015 by University Hospital, Limoges.
Recruitment status was:  Recruiting
First Posted : February 28, 2011
Last Update Posted : September 1, 2015
Information provided by (Responsible Party):
University Hospital, Limoges

Brief Summary:
To assess diagnostic accuracy of flow cytometry applied to the diagnosis of allergy to neuro-muscular blockers and to the determination of the neuro-muscular blocker (NMB) which may be used for an ulterior anaesthesia in case of allergy to one given NMB.

Condition or disease Intervention/treatment Phase
Allergy Other: Blood simple Not Applicable

Detailed Description:
The flow cytometric protocol used for this study, was based on basophil selection by an anti- CCR3 and the analysis of basophil activation by the respective up and down regulation of the CD63 and IgE markers as described previously. Basophil activation was expressed in percentage CD63 expression on activated basophils and in activation index involving IgE and CD63 markers and calculated by a specific algorithm developed by our group.. Our aim is to test a sufficient number of patients in order to be able to establish the ROC curves related to the allergen type tested and validate the use of an allergen mixture (NMB mix containing the 7 usual NMB at the optimal activation concentrations). Patients will be included during the post-anaesthetic consultation on the basis of the diagnosis of an IgE dependant per-anaesthetic reaction. The allegro-anaesthetist diagnostical habits won't be changed.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic
Official Title: Diagnostic Accuracy of Flow Cytometry Applied to the Diagnosis of Peri-anaesthesic Reactions Induced by Neuromuscular Blockers
Study Start Date : April 2011
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Intervention Details:
    Other: Blood simple
    Single Blood simple at Day 1

Primary Outcome Measures :
  1. Allergy diagnosis assessed by cytometry flow data [ Time Frame: At Day 1 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients aged at least 18 years,
  • patients having experienced an IgE dependant per-anaesthetic reaction
  • affiliated to a social security

Exclusion criteria:

  • patients having taken anti-histamine drugs and corticoids during the last 8 days
  • patients submitted to a juridical protection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01305161

Contact: Jean SAINTE-LAUDY, MD

Service d'Allergologie Recruiting
Angers, France
Contact: Mireille DROUET, MD   
Principal Investigator: Mireille DROUET, MD         
Sub-Investigator: Gilles RENIER, MD         
Service d'Immuno-allergologie Recruiting
Bordeaux, France
Principal Investigator: Stéphane GUEZ, MD         
Laboratoire Immunologie et Immunogénétique Recruiting
Limoges, France
Contact: Jean SAINTE-LAUDY, MD   
Sub-Investigator: Isabelle Orsel, MD         
Service d'Anesthésie Réanimation Recruiting
Nancy, France
Principal Investigator: Michel MERTES, MD         
Sub-Investigator: Claudie MOUTON, MD         
Sub-Investigator: Chantal KOHLER, MD         
Sponsors and Collaborators
University Hospital, Limoges

Responsible Party: University Hospital, Limoges Identifier: NCT01305161     History of Changes
Other Study ID Numbers: I09010
First Posted: February 28, 2011    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015

Keywords provided by University Hospital, Limoges:
2 Neuromuscular blockers

Additional relevant MeSH terms:
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs