Hypersensitivity, DrugSERAPNCT04654923
GERAP's Epidemiological Survey on Perioperative Hypersensitivity Reactions
An observational study of Hypersensitivity, Drug, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Hypersensitivity, Drug
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2020to 12 May 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subject having experienced a perioperative hypersensitivity reaction
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service d'anesthésie-réanimation - CHU de Strasbourg - France
Strasbourg, 67091
Paul-Michel MERTES, MD, PhD, 33 3 69 55 04 44, paul-michel.mertes@chru-strasbourg.fr
Charles TACQUARD, MD, 33.3.69.55.16.08, charlesambroise.tacquard@chru-strasbourg.fr
About this study
Official title: 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.
- Conditions
- Hypersensitivity, Drug
- Keywords
- anaphylaxis, perioperative, hypersensitivity reactions, neuromuscular blocking agents, hypnotics
- Medical subject headings
- Drug Hypersensitivity, Anaphylaxis, Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective analysis of incidence of all perioperative hypersensitivity reactions referred in an allegro-anesthetic
Measured: Outcome is analysed every 2 years over a 10 years period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start12 Nov 2020
- Primary completion12 May 2031 (estimated)
- Study completion12 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypersensitivity, DrugStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul-Michel MERTES, MD, PhD, Study director, Strasbourg University Hospitals - Anesthesia-intensive care unitCharles TACQUARD, MD, Principal investigator, Strasbourg University Hospitals - Anesthesia-intensive care unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654923
- Sponsor's protocol ID
- 8038
- Acronym
- SERAP
- Status last verified
- Apr 2023
- First submitted
- 3 Dec 2020
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38493055
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Survey on Perioperative Hypersensitivity Reactions in France by the GERAP Network (Groupe d'étude Des réactions Anaphylactiques périopératoires)
- ClinicalTrials.gov ID
- NCT04654923
- Acronym / sponsor ID
- SERAP / 8038
- Conditions
- Hypersensitivity, Drug
- Keywords
- anaphylaxis, perioperative, hypersensitivity reactions, neuromuscular blocking agents, hypnotics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 12 May 2031 (estimated)
- Study completion
- 12 May 2031 (estimated)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subject having experienced a perioperative hypersensitivity reaction
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Derived from this study: PubMed 38493055Tacquard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul-Michel MERTES, MD, PhD study director
Strasbourg University Hospitals - Anesthesia-intensive care unit
Charles TACQUARD, MD principal investigator
Strasbourg University Hospitals - Anesthesia-intensive care unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypersensitivity, Drug, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul-Michel MERTES, MD, PhD (33 3 69 55 04 44, paul-michel.mertes@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04654923, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.