AllergyCYPREANENCT01305161
Flow Cytometry Applied to the Diagnosis of Peri-anaesthesic Reactions
A study testing Blood simple in people with Allergy, run by University Hospital, Limoges at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergy
- What is being tested?
- Blood simple
- How many people
- 129 participants
- Where
- 4 sitesFrance
- Study dates
- Apr 2011to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged at least 18 years,
- patients having experienced an IgE dependant per-anaesthetic reaction
- affiliated to a social security
Who cannot join
- patients having taken anti-histamine drugs and corticoids during the last 8 days
- patients submitted to a juridical protection
Trial locations and contacts
4 sites in 1 country.
France4 sites
Service d'Allergologie
Angers
Service d'Immuno-allergologie
Bordeaux
Laboratoire Immunologie et Immunogénétique
Limoges
Service d'Anesthésie Réanimation
Nancy
About this study
Official title: Diagnostic Accuracy of Flow Cytometry Applied to the Diagnosis of Peri-anaesthesic Reactions Induced by Neuromuscular Blockers
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.
Read the 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
- Being tested
- Blood simple
- Keywords
- 1Allergy, 2 Neuromuscular blockers
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood simpleOther
Single Blood simple at Day 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergy diagnosis assessed by cytometry flow data
Measured: At Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2019
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305161
- Sponsor's protocol ID
- I09010
- Acronym
- CYPREANE
- Status last verified
- Jan 2019
- First submitted
- 24 Feb 2011
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Place of the basophil activation test in the diagnosis of neuromuscular blocking agent's allergy. Immunological multicenter study. See : https://www.sciencedirect.com/science/article/pii/S1877032024003920 https://doi.org/10.1016/j.reval.2024.104171
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Flow Cytometry Applied to the Diagnosis of Peri-anaesthesic Reactions Induced by Neuromuscular Blockers
- ClinicalTrials.gov ID
- NCT01305161
- Acronym / sponsor ID
- CYPREANE / I09010
- Conditions
- Allergy
- Keywords
- 1Allergy, 2 Neuromuscular blockers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 28 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged at least 18 years,
- patients having experienced an IgE dependant per-anaesthetic reaction
- affiliated to a social security
Key exclusion criteria (2 listed)
- patients having taken anti-histamine drugs and corticoids during the last 8 days
- patients submitted to a juridical protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood simpleSingle Blood simple at Day 1 | Other | – |
Primary outcome
Allergy diagnosis assessed by cytometry flow data
Time frame: At Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Results publicationPlace of the basophil activation test in the diagnosis of neuromuscular blocking agent's allergy. Immunological multicenter study. See : https://www.sciencedirect.com/science/article/pii/S1877032024003920 https://doi.org/10.1016/j.reval.2024.104171
- Results of the researchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood simple in people with Allergy, run by University Hospital, Limoges at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allergy diagnosis assessed by cytometry flow data (time frame: At Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01305161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.