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.

Study Overview

• Status: Recruiting
• Conditions: Anaphylaxis
• Intervention / Treatment: Other: not applicable, observational study

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 Type: Observational
• Enrollment (Anticipated): 20000

Contacts and Locations

• Study Contact: Name: Sabine Dölle-Bierke, PhD; Phone Number: +49 30 450 518367; Email: sabine.doelle@charite.de
• Study Contact Backup: Name: Margitta Worm, Prof.; Phone Number: +49 30 450 518105; Email: margitta.worm@charite.de

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charité - Universitätsmedizin Berlin
    • Contact: Sabine Dölle-Bierke, PhD; Phone Number: +49 30 450 518367; Email: sabine.doelle@charite.de
    • Contact: Margitta Worm, Prof.; Phone Number: +49 30 450 518105; Email: margitta.worm@charite.de
    • Principal Investigator: Margitta Worm, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who experienced a severe anaphylactic reaction and presenting in a participating center

Description

Inclusion Criteria:

• Anaphylactic reaction within the past 12 months

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anaphylactic reaction (observational); Patients who experienced an anaphylactic reaction will be observed	Other: not applicable, observational study; Patients do not receive intervention; observational study

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Study Chair: Margitta Worm, Prof., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2007
• Primary Completion (ANTICIPATED): December 1, 2030
• Study Completion (ANTICIPATED): December 1, 2030

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (ACTUAL): January 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Anaphylaxis
• Other Study ID Numbers: Anaphylaxis Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No