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GERAP's Epidemiological Survey on Perioperative Hypersensitivity Reactions

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 7 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04654923
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Strasbourg, France
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Paul-Michel MERTES, MD, PhD
Principal Investigator Affiliation Strasbourg University Hospitals - Anesthesia-intensive care unit
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hypersensitivity, Drug

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Service d'anesthésie-réanimation, Strasbourg, France

Status

Recruiting

Address

Service d'anesthésie-réanimation

Strasbourg, , 67091

Site Contact

Paul-Michel MERTES, MD, PhD

paul-michel.mertes@chru-strasbourg.fr

33 3 69 55 04 44

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