GERAP's Epidemiological Survey on Perioperative Hypersensitivity Reactions

NCT ID: NCT04654923

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-12

Study Completion Date

2031-05-12

Brief Summary

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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.

Detailed Description

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Conditions

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Hypersensitivity, Drug

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul-Michel MERTES, MD, PhD

Role: STUDY_DIRECTOR

Strasbourg University Hospitals - Anesthesia-intensive care unit

Charles TACQUARD, MD

Role: PRINCIPAL_INVESTIGATOR

Strasbourg University Hospitals - Anesthesia-intensive care unit

Locations

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Service d'anesthésie-réanimation - CHU de Strasbourg - France

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Paul-Michel MERTES, MD, PhD

Role: CONTACT

33 3 69 55 04 44

Charles TACQUARD, MD

Role: CONTACT

33.3.69.55.16.08

Facility Contacts

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Paul-Michel MERTES, MD, PhD

Role: primary

33 3 69 55 04 44

Charles TACQUARD, MD

Role: backup

33.3.69.55.16.08

References

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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.

Reference Type DERIVED
PMID: 38493055 (View on PubMed)

Other Identifiers

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8038

Identifier Type: -

Identifier Source: org_study_id

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