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

Recruiting

• Conditions: Anaphylaxis
• Interventions: Other: not applicable, observational study

• Registration Number: NCT05210543
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-01-01
• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-27
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

• Anaphylactic reaction within the past 12 months

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anaphylactic reaction (observational)	not applicable, observational study	Patients who experienced an anaphylactic reaction will be observed

Primary Outcome Measures

Name	Time	Method
Influence of risk factors	10 years	Correlation between risk factors (age, epiphenomenon, comorbidity) and severity of anaphylaxis

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany