Flow Cytometry Applied to the Diagnosis of Peri-anaesthesic Reactions

NCT ID: NCT01305161

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2021-01-31

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.

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.

Conditions

Allergy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Blood simple

Single Blood simple at Day 1

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service d'Allergologie

Angers, , France

Service d'Immuno-allergologie

Bordeaux, , France

Laboratoire Immunologie et Immunogénétique

Limoges, , France

Service d'Anesthésie Réanimation

Nancy, , France

Countries

France

References

Place of the basophil activation test in the diagnosis of neuromuscular blocking agent's allergy. Immunological multicenter study

Reference Type: BACKGROUND

Other Identifiers

I09010

Identifier Type: -

Identifier Source: org_study_id