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

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

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 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

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

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

University Hospital, Strasbourg, France

Investigators

  • 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)

November 12, 2020

Primary Completion (Anticipated)

May 12, 2031

Study Completion (Anticipated)

May 12, 2031

Study Registration Dates

First Submitted

December 3, 2020

First Submitted That Met QC Criteria

December 3, 2020

First Posted (Actual)

December 4, 2020

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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