GERAP's Epidemiological Survey on Perioperative Hypersens... | NCT04654923 | Trialant
NCT04654923
Sponsor
University Hospital, Strasbourg, France
Status
Recruiting
Last Update Posted
May 3, 2023Actual
Enrollment
3,000Estimated
Phase
Not provided
Conditions
Hypersensitivity, Drug
Interventions
Not provided
Countries
France
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT04654923
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
8038
Secondary IDs
Not provided
Brief Title
GERAP's Epidemiological Survey on Perioperative Hypersensitivity Reactions
Official Title
Epidemiological Survey on Perioperative Hypersensitivity Reactions in France by the GERAP Network (Groupe d'étude Des réactions Anaphylactiques périopératoires)
Acronym
SERAP
Organization
University Hospital, Strasbourg, FranceOTHER
Status Module
Record Verification Date
Apr 2023
Overall Recruitment Status or Expanded Access Status
Recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 12, 2020Actual
Primary Completion Date
May 12, 2031Estimated
Completion Date
May 12, 2031Estimated
First Submitted Date
Dec 3, 2020
First Submission Date that Met QC Criteria
Dec 3, 2020
First Posted Date
Dec 4, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 2, 2023
Last Update Posted Date
May 3, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
University Hospital, Strasbourg, FranceOTHER
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Hypersensitivity, Drug
Keywords
anaphylaxis
perioperative
hypersensitivity reactions
neuromuscular blocking agents
hypnotics
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
No
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
3,000Estimated
Arms/Interventions Module
No data available
No data is available for this block.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility 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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
7 Years
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Subject having experienced a perioperative hypersensitivity reaction
Sampling Method
Non-Probability Sample
Contacts/Locations Module
Central Contacts
Name
Role
Phone
Extension
Email
Paul-Michel MERTES, MD, PhD
Contact
33 3 69 55 04 44
paul-michel.mertes@chru-strasbourg.fr
Charles TACQUARD, MD
Contact
33.3.69.55.16.08
charlesambroise.tacquard@chru-strasbourg.fr
Overall Officials
Name
Affiliation
Role
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
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Service d'anesthésie-réanimation - CHU de Strasbourg - France
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.