Flow Cytometry Applied to the Diagnosis of Peri-anaesthesic Reactions (CYPREANE)
Primary Purpose
Allergy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood simple
Sponsored by
About this trial
This is an interventional diagnostic trial for Allergy focused on measuring 1Allergy, 2 Neuromuscular blockers
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
Sites / Locations
- Service d'Allergologie
- Service d'Immuno-allergologie
- Laboratoire Immunologie et Immunogénétique
- Service d'Anesthésie Réanimation
Outcomes
Primary Outcome Measures
Allergy diagnosis assessed by cytometry flow data
Secondary Outcome Measures
Full Information
NCT ID
NCT01305161
First Posted
February 24, 2011
Last Updated
January 9, 2019
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT01305161
Brief Title
Flow Cytometry Applied to the Diagnosis of Peri-anaesthesic Reactions
Acronym
CYPREANE
Official Title
Diagnostic Accuracy of Flow Cytometry Applied to the Diagnosis of Peri-anaesthesic Reactions Induced by Neuromuscular Blockers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy
Keywords
1Allergy, 2 Neuromuscular blockers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Blood simple
Intervention Description
Single Blood simple at Day 1
Primary Outcome Measure Information:
Title
Allergy diagnosis assessed by cytometry flow data
Time Frame
At Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Service d'Allergologie
City
Angers
Country
France
Facility Name
Service d'Immuno-allergologie
City
Bordeaux
Country
France
Facility Name
Laboratoire Immunologie et Immunogénétique
City
Limoges
Country
France
Facility Name
Service d'Anesthésie Réanimation
City
Nancy
Country
France
12. IPD Sharing Statement
Learn more about this trial
Flow Cytometry Applied to the Diagnosis of Peri-anaesthesic Reactions
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