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NCT Number: NCT05210543

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

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.

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Key information

Conditions

Anaphylaxis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Anaphylactic reaction within the past 12 months

Exclusion criteria

-

Treatment and study plan

not applicable, observational study

Other

Patients do not receive intervention; observational study

Primary outcomes

  1. Influence of risk factors

    Time frame: 10 years

    Correlation between risk factors (age, epiphenomenon, comorbidity) and severity of anaphylaxis

Secondary outcomes

  1. Epiphenomenon

    Time frame: 10 years

    Correlation between epiphenomenoa of the anaphylaxis and the frequency of allergic reactions

  2. Current use of adrenaline

    Time frame: 10 years

    Assessment of acute treatments with adrenaline

  3. Future use of adrenaline

    Time frame: 10 years

    Comparison of the frequencies of the use of adrenaline from beginning to end of the observation

  4. Country-specific differences in anaphylaxis handling

    Time frame: 10 years

    Comparison of the triggers, diagnosis, treatment and prophylaxis of anaphylactic reactions throughout different countries

  5. Biomarkers

    Time frame: 10 years

    Identification of biomarkers (e.g. PGE2 via ELISA, Tryptase via ImmunoCAP) for anaphylactic reactions

  6. Epigenetics

    Time frame: 10 years

    Correlation of genetic and epigenetic factors with the pathogenesis of severe allergic reactions

Study contacts

Contact information is provided by the study sponsor or research team.

Margitta Worm, Prof.

CONTACT

[email protected]

+49 30 450 518105

Sabine Dölle-Bierke, PhD

CONTACT

[email protected]

+49 30 450 518367

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2007
Primary completion
2030
Study completion
2030
First posted
Jan 27, 2022
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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