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Recruiting NCT04654923

GERAP's Epidemiological Survey on Perioperative Hypersensitivity Reactions

Observational Hypersensitivity, Drug

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hypersensitivity, Drug. Basic parameters: from 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Epidemiological Survey on Perioperative Hypersensitivity Reactions in France by the GERAP Network (Groupe d'étude Des réactions Anaphylactiques périopératoires)

Overview

Perioperative hypersensitivity reactions are still associated with significant morbidity and mortality despite early recognition and use of epinephrine. The epidemiology of these reactions evolves over time and changes with clinical practice. The main objective is to study the epidemiology of these reactions over a 10-year period, including patient phenotype, reaction phenotype and outcome of the allergic work-up.

Primary outcome measures

  • Retrospective analysis of incidence of all perioperative hypersensitivity reactions referred in an allegro-anesthetic [Time frame: Outcome is analysed every 2 years over a 10 years period]

Eligibility criteria

Inclusion criteria

  • Minor and major subject
  • Subject having experienced a perioperative hypersensitivity reaction between January the 1st 2017 and December the 31st 2027.
  • Referred for an allegro-anesthetic workup
  • Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion criteria

  • Subject having expressed opposition to participating in the study
  • Inability to provide the subject with research information
  • Subject under guardianship or guardianship
  • Subject under safeguard of justice

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • Service d'anesthésie-réanimation - CHU de Strasbourg - France — Strasbourg

Publications

  • Tacquard C, Serrier J, Viville S, Chiriac AM, Franchina S, Gouel-Cheron A, Giraudon A, Le Guen M, Le Quang D, Malinovsky JM, Petitpain N, Demoly P, Mertes PM; GERAP study group. Epidemiology of perioperative anaphylaxis in France in 2017-2018: the 11th GERAP survey. Br J Anaesth. 2024 Jun;132(6):1230-1237. doi: 10.1016/j.bja.2024.01.044. Epub 2024 Mar 16. PMID 38493055

Identifiers

NCT: NCT04654923 · 8038

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗