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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05210543
Other study ID # Anaphylaxis Registry
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2007
Est. completion date December 2030

Study information

Verified date February 2023
Source Charite University, Berlin, Germany
Contact Margitta Worm, Prof.
Phone +49 30 450 518105
Email margitta.worm@charite.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20000
Est. completion date December 2030
Est. primary completion date December 2030
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Anaphylactic reaction within the past 12 months Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
not applicable, observational study
Patients do not receive intervention; observational study

Locations

Country Name City State
Germany Charité - Universitätsmedizin Berlin Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

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