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NCT01305161 Clinical Trial

Flow Cytometry Applied to the Diagnosis of Peri-anaesthesic Reactions

Allergy Clinical Trial

— CYPREANE  

Official title:
Diagnostic Accuracy of Flow Cytometry Applied to the Diagnosis of Peri-anaesthesic Reactions Induced by Neuromuscular Blockers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01305161
Other study ID # I09010
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2011

Study information
Verified date January 2019
Source University Hospital, Limoges
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 129
Est. completion date
Est. primary completion date January 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Blood simple
Single Blood simple at Day 1

Locations
Country Name City State
France Service d'Allergologie Angers
France Service d'Immuno-allergologie Bordeaux
France Laboratoire Immunologie et Immunogénétique Limoges
France Service d'Anesthésie Réanimation Nancy

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Allergy diagnosis assessed by cytometry flow data At Day 1
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