NCT04654923

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
61mo left

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress52%
Nov 2020May 2031

Study Start

First participant enrolled

November 12, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2031

Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

10.5 years

First QC Date

December 3, 2020

Last Update Submit

May 2, 2023

Conditions

Keywords

anaphylaxisperioperativehypersensitivity reactionsneuromuscular blocking agentshypnotics

Outcome Measures

Primary Outcomes (1)

  • Retrospective analysis of incidence of all perioperative hypersensitivity reactions referred in an allegro-anesthetic

    Outcome is analysed every 2 years over a 10 years period

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subject having experienced a perioperative hypersensitivity reaction

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Strasbourg, 67091, France

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Drug HypersensitivityAnaphylaxisHypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersHypersensitivity, ImmediateImmune System Diseases

Study Officials

  • Paul-Michel MERTES, MD, PhD

    Strasbourg University Hospitals - Anesthesia-intensive care unit

    STUDY DIRECTOR
  • Charles TACQUARD, MD

    Strasbourg University Hospitals - Anesthesia-intensive care unit

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 4, 2020

Study Start

November 12, 2020

Primary Completion (Estimated)

May 12, 2031

Study Completion (Estimated)

May 12, 2031

Last Updated

May 3, 2023

Record last verified: 2023-04

Locations