GERAP's Epidemiological Survey on Perioperative Hypersensitivity Reactions (SERAP)

May 2, 2023 updated by: University Hospital, Strasbourg, France

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service d'anesthésie-réanimation - CHU de Strasbourg - France
        • Principal Investigator:
          • Sébastien LEFEVRE, MD
        • Principal Investigator:
          • MARTINE MORISSET, MD, PHD
        • Contact:
        • Principal Investigator:
          • Charles TACQUARD, MD
        • Sub-Investigator:
          • Rodolphe STENGER, MD
        • Principal Investigator:
          • Jean-Marc MALINOVSKY, MD, PhD
        • Principal Investigator:
          • Florence LAKKIS-CASTELAIN, MD
        • Principal Investigator:
          • Christelle PELLERIN, MD
        • Principal Investigator:
          • Elleni VAIA, MD
        • Principal Investigator:
          • Delphine MARIOTTE, MD
        • Principal Investigator:
          • Yann OLLIVIER, MD
        • Principal Investigator:
          • Georgia DALAMPIRA, MD
        • Principal Investigator:
          • Daniela MUTI, MD
        • Sub-Investigator:
          • Omar OUTTAS, MD
        • Sub-Investigator:
          • Solène HUSSER, MD
        • Principal Investigator:
          • Sandrine SELTZE, MD
        • Sub-Investigator:
          • Etienne BAUDOUIN, MD
        • Principal Investigator:
          • Alain FACON, MD
        • Principal Investigator:
          • Isabelle ORSEL, MD
        • Principal Investigator:
          • Nathalie DIOT-JUNIQUE, MD
        • Sub-Investigator:
          • Christine MULLET, MD
        • Principal Investigator:
          • Anca CHIRIAC, MD
        • Sub-Investigator:
          • Pascal DEMOLY, MD, PhD
        • Principal Investigator:
          • Anaïs PIPET, MD
        • Sub-Investigator:
          • Luc COLAS, MD
        • Sub-Investigator:
          • Sandrine TERCINET, MD
        • Principal Investigator:
          • Sylvie DECAGNY, MD
        • Principal Investigator:
          • Emmanuelle AGUINET, MD
        • Principal Investigator:
          • Bertrand LEMAIRE, MD
        • Principal Investigator:
          • Aurélie GOUEL CHERON, MD
        • Sub-Investigator:
          • Catherine NEUKIRCH, MD
        • Principal Investigator:
          • Christine FESSENMEYER, MD
        • Principal Investigator:
          • Chantal KARILA, MD
        • Principal Investigator:
          • Hafida GAOUAR, MD
        • Principal Investigator:
          • Morgan LE GUEN, MD
        • Principal Investigator:
          • David LEPAGE, MD
        • Principal Investigator:
          • Alice SERINGULIAN, MD
        • Principal Investigator:
          • Marion VERDAGUER, MD
        • Principal Investigator:
          • Valérie RENAULD, MD
        • Principal Investigator:
          • Cécile ROCHEFORT MOREL, MD
        • Sub-Investigator:
          • Sabrina DESSARD, MD
        • Principal Investigator:
          • Yannick MEUNIER, MD
        • Sub-Investigator:
          • Sébastien FRANCHINA, MD
        • Principal Investigator:
          • Cédric DELZANNO, MD
        • Principal Investigator:
          • Charles DZVIGA, MD
        • Principal Investigator:
          • Claire MAIHOL, MD
        • Principal Investigator:
          • Cyrille HOARAU, MD
        • Principal Investigator:
          • Carine BILLARD, MD
        • Principal Investigator:
          • Eva SERRANO, MD
        • Sub-Investigator:
          • Marion GOUITAA, MD
        • Sub-Investigator:
          • Adrien MARZIALE, MD
        • Principal Investigator:
          • Guillaume POUESSEL, MD
        • Principal Investigator:
          • Béatrice CAVESTRI-MACIEJASZ, MD
        • Sub-Investigator:
          • Nicolas JUST, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subject having experienced a perioperative hypersensitivity reaction

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Outcome is analysed every 2 years over a 10 years period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Strasbourg, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Charles TACQUARD, MD, Strasbourg University Hospitals - Anesthesia-intensive care unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 12, 2031

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 12, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 8038

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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