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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05210543
Enrollment
20000
Registered
2022-01-27
Start date
2007-01-01
Completion date
2030-12-31
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaphylaxis

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.

Interventions

Patients do not receive intervention; observational study

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Anaphylactic reaction within the past 12 months

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Influence of risk factors10 yearsCorrelation between risk factors (age, epiphenomenon, comorbidity) and severity of anaphylaxis

Secondary

MeasureTime frameDescription
Current use of adrenaline10 yearsAssessment of acute treatments with adrenaline
Future use of adrenaline10 yearsComparison of the frequencies of the use of adrenaline from beginning to end of the observation
Epiphenomenon10 yearsCorrelation between epiphenomenoa of the anaphylaxis and the frequency of allergic reactions
Biomarkers10 yearsIdentification of biomarkers (e.g. PGE2 via ELISA, Tryptase via ImmunoCAP) for anaphylactic reactions
Epigenetics10 yearsCorrelation of genetic and epigenetic factors with the pathogenesis of severe allergic reactions
Country-specific differences in anaphylaxis handling10 yearsComparison of the triggers, diagnosis, treatment and prophylaxis of anaphylactic reactions throughout different countries

Countries

Germany

Contacts

Primary ContactMargitta Worm, Prof.
margitta.worm@charite.de+49 30 450 518105
Backup ContactSabine Dölle-Bierke, PhD
sabine.doelle@charite.de+49 30 450 518367

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026