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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Hospital, Limoges
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01305161
First received: February 24, 2011
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 212
Study Start Date: April 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: April 2015 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT01305161

Contacts
Contact: Jean SAINTE-LAUDY, MD 05.55.05.61.84 jean.sainte-laudy@chu-limoges.fr

Locations
France
Service d'Allergologie Recruiting
Angers, France
Contact: Mireille DROUET, MD       midrouet@chu-angers.fr   
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    05.55.05.61.84    jean.sainte-laudy@chu-limoges.fr   
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

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01305161     History of Changes
Other Study ID Numbers: I09010
Study First Received: February 24, 2011
Last Updated: July 14, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Limoges:
1Allergy
2 Neuromuscular blockers

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

ClinicalTrials.gov processed this record on September 16, 2014