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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2015 by University Hospital, Limoges.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
University Hospital, Limoges Identifier:
First received: February 24, 2011
Last updated: August 31, 2015
Last verified: August 2015
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 Intervention
Allergy Other: Blood simple

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University Hospital, Limoges:

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

Estimated Enrollment: 212
Study Start Date: April 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Blood simple
    Single Blood simple at Day 1
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.

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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: University Hospital, Limoges Identifier: NCT01305161     History of Changes
Other Study ID Numbers: I09010
Study First Received: February 24, 2011
Last Updated: August 31, 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 processed this record on September 21, 2017