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Evaluation of Medical Care and Patient's Knowledge About the Behavior to Take on Secondary Prevention of Anaphylaxis

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ClinicalTrials.gov Identifier: NCT03953482
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:

Anaphylaxis is a hypersensitivity reaction systemic, generalized, severe, life-threatening that may result from exposure to a triggering factor. The prevalence of anaphylaxis is 0.05 to 2% in the general population. Most reactions appear within 30 minutes after contact with the triggering factor and last up to 6 hours. The main triggering factors are: 1/food, 2/hymenopteran bites, 3/drugs. The main treatment is the early administration of adrenaline by Intramuscular route on medical prescription or by AAI (adrenaline auto-injector) associated with the exclusion of the allergen. Adrenaline treatment should be administered as soon as possible, a failure or delay in the use of adrenaline is a risk factor for death. Anaphylaxis is a chronic disease and the patient must be informed from the first episode about the risk of recurrence and the risk of death he is exposed to. Patient education is essential for the complete removal of the triggering factor, recognition of anaphylaxis symptoms and use of AAI. The risk of recurrence is high given the difficulty to completely eliminate the favourable factor (mainly food causes and hymenopteran bites): 1/3 of deaths from food anaphylaxis occur at home, and the peak mortality rate is between 10 and 30 years old. The diagnosis of anaphylaxis can be difficult because the symptomatology can be so varied. It is under-diagnosed, which leads to a lack of medical care and therefore an under-prescription of AAI. Some American studies identifying emergency room visits for anaphylaxis find that in less than 30% of cases there is a prescription for AAI, in less than 40% of advices about triggering factor's eviction and in less than 20% a guidance to an allergology consultation. In France, the HAS published in 2013 a procedure to be followed after the treatment of a suspected anaphylaxis: the patient's management must be diagnostic, therapeutic and educational. It must be systematically based on three axes:

  • the prescription of AAI with an explanation of its use,
  • the provision of written information on the mechanism and symptoms of anaphylaxis, attitude to be followed in event of an anaphylactic reaction, and need for eviction if the allergen has been identified,
  • guidance to an allergology consultation.

Therapeutic education for anaphylactic patients is essential given the risk involved. In an American study, it was shown that only 60% of teens and young adults suffering from food allergies report having AAI systematically with them. Information and education is therefore essential for these patients.


Condition or disease
Anaphylaxis

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Medical Care and Patient's Knowledge About the Behavior to Take on Secondary Prevention of Anaphylaxis
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : August 16, 2019
Estimated Study Completion Date : October 16, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anaphylaxis




Primary Outcome Measures :
  1. Patient's medical management after a first episode of anaphylaxis [ Time Frame: Day 0 ]

    Percentage of patients who had management with:

    • an adrenaline auto-injector prescription (yes/no)
    • an eviction advice distribution (yes/no),
    • an allergology consultation (yes/no).


Secondary Outcome Measures :
  1. Patient's knowledge of attitude to have with anaphylaxis [ Time Frame: Day0 ]
    Percentage of correct answers to the study-specific questionnaire related to knowledge of attitude to have with a new anaphylactic reaction.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with a history of an anaphylactic reaction
Criteria

Inclusion Criteria:

  • Patient whose age ≥ 18 years
  • Francophone patient
  • Patient not opposing his participation in the research protocol
  • Patient with a history of an anaphylactic reaction

Exclusion Criteria:

  • Patient under tutorship or curatorship
  • Patient deprived of liberty
  • Patient presenting an allergic reaction or an anaphylaxis
  • For patients presenting to emergencies at Groupe Hospitalier Paris Saint-Joseph (GHPSJ) : Unstable health estate (gravity criteria hemodynamic, respiratory or neurological and any pathologies with a severity that do not allow the questionnaire to be answered).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953482


Contacts
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Contact: Eloïse TRABATTONI, MD 01.44.12.72.24 etrabattoni@hpsj.fr

Locations
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France
Groupe Hospitalier Paris Saint Joseph Recruiting
Paris, Ile-de-France, France, 75014
Contact: Helene BEAUSSIER, PharmD, PhD    01 44 12 70 38 ext +33    hbeaussier@hpsj.fr   
Principal Investigator: Heloise PREVANA, MD         
Maison de santé porte de Vanves Recruiting
Paris, France, 75014
Contact: jean.laurent.thebault@gmail.com THEBAULT, MD    01.40.43.43.20    jean.laurent.thebault@gmail.com   
Principal Investigator: jean.laurent.thebault@gmail.com THEBAULT, MD         
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT03953482     History of Changes
Other Study ID Numbers: PREVANA
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anaphylaxis
Shock
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes