Acquisition and Long-term Observation of Patients With Severe Allergic Reactions

Study Overview
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Brief Summary
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The Anaphylaxis Registry aims to assess data in a standardized form about symptoms, triggers, cofactors and therapy management from patients who experienced an anaphylactic reaction. This should improve diagnosis and long-term management of these life-threatening allergic reactions.

Detailed Description
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A better understanding of the triggers and pathology of anaphylactic reactions could lead to a better diagnosis and prophylaxis to avoid the occurence of these life-threatening allergic reactions. This can be an advantage for affected persons regarding the their treatment and long-term management. The Anaphylaxis Registry is an opportunity to gather these standardized data. The blood sampling is optional for the patient, however, it will contribute to the better understanding of the sensitization profile and possible mechanisms. Recent publications showed a correlation between an anaphylactic reaction and certain biomarkers. Those data will be validated in a larger number of population with identification of further biomarkers. It is presumed that certain genetic and epigenetic polymorphisms are abundant for patients who experienced an anaphylaxis. To summarize, this study aims to contribute to a better understanding of the anaphylaxis in general, the diagnosis, and the prognosis with different severities. With the identification of a certain trigger, the obtained understanding may help to decrease the risk of or prevent future repeating reactions.

Official Title
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Acquisition and Long-term Observation of Patients With Severe Allergic Reactions

Conditions
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Anaphylaxis

Intervention / Treatment
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* Other: not applicable, observational study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anaphylactic reaction within the past 12 months Exclusion Criteria: -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anaphylactic reaction (observational)<br>Patients who experienced an anaphylactic reaction will be observed | Other: not applicable, observational study<br>* Patients do not receive intervention; observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of risk factors | Correlation between risk factors (age, epiphenomenon, comorbidity) and severity of anaphylaxis | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epiphenomenon | Correlation between epiphenomenoa of the anaphylaxis and the frequency of allergic reactions | 10 years | 
| Current use of adrenaline | Assessment of acute treatments with adrenaline | 10 years | 
| Future use of adrenaline | Comparison of the frequencies of the use of adrenaline from beginning to end of the observation | 10 years | 
| Country-specific differences in anaphylaxis handling | Comparison of the triggers, diagnosis, treatment and prophylaxis of anaphylactic reactions throughout different countries | 10 years | 
| Biomarkers | Identification of biomarkers (e.g. PGE2 via ELISA, Tryptase via ImmunoCAP) for anaphylactic reactions | 10 years | 
| Epigenetics | Correlation of genetic and epigenetic factors with the pathogenesis of severe allergic reactions | 10 years |