NCT05848986

Brief Summary

Anaphylactic shock is the most severe expression of immediate hypersensitivity reactions. The mechanisms leading to these reactions are still poorly understood and may involve platelets, especially in the most severe forms. The IgE ( ImmunoglobulineE)-mediated mechanism, involving the FcERI(the high-affinity receptor for the Fc region of immunoglobulin E (IgE) receptor present on the surface of mast cells and basophilic cells, is the most common mechanism. The receptors FcERI and FcERII are also described as being present on the surface of blood platelets, which would imply their activation along with the other cells involved. However, studies showing the presence of the FcERI/RII receptors on blood platelets suffer from many biases. The main objective of the research is to study whether the FcERI/RII receptors are present and functional on the surface of blood platelets from allergic patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

May 8, 2023

Status Verified

March 1, 2023

Enrollment Period

Same day

First QC Date

March 27, 2023

Last Update Submit

May 4, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence of functionnal FcERI/RII receptors on the surface of blood platelets from allergic patients

    After confirmation of the allergy by a well conducted allergy workup

    1 day

Interventions

Analysis of blood samples from a health sample's allergic patients and analysis with flow cytometry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients assessed in the allergy clinic of the Strasbourg University Hospital

You may qualify if:

  • Age \> 18 years-old
  • With a protein/drug allergy (hymenoptera, arachide, amoxicillin)
  • Confirmed by skin tests and/or challenge test
  • With specific IgEs

You may not qualify if:

  • Patients who refuse to participate to this study
  • Patients unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Les Hôpitaux Universitaires

Strasbourg, 67091, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, platelet rich plasma Obtained from a constituted biocollection.

MeSH Terms

Conditions

Hypersensitivity

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Cell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • CHARLES AMBROISE TACQUARD, MD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2023

First Posted

May 8, 2023

Study Start

June 1, 2023

Primary Completion

June 1, 2023

Study Completion

April 1, 2025

Last Updated

May 8, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations