Mechanisms of Anaphylaxis

NCT03182491 — Active not recruiting, 40 participants, Haukeland University Hospital

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Registry	NCT03182491, acronym ANAMEK
Status	Active not recruiting
Study type	Observational
Enrollment	40 (Estimated)
Sponsor	Haukeland University Hospital (Other)
Conditions	Anaphylaxis, Allergy, Transfusion Reaction, Febrile Transfusion Reaction
Interventions	Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT) (Diagnostic test)
Dates	start 2017-04-28, primary completion 2028-12-31 (estimated), completion 2028-12-31 (estimated), first posted 2017-06-09, last updated 2026-10-21
Locations	1 site in Norway

-Summary

The purpose of this study is to explore different mechanisms for anaphylaxis and find novel biomarkers for this hypersensitivity syndrome. The study participants are patients with anaphylaxis, patients with mild allergic reactions, and patients with febrile transfusion reactions. The investigators will also include a group of healthy controls.

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+Arms and interventions

Arm	Type	Interventions	Description
Anaphylaxis		Diagnostic Test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)
Febrile transfusion reactions		Diagnostic Test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)
Mild allergic reactions		Diagnostic Test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)
Healthy controls		Diagnostic Test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)

Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT) (Diagnostic test): Analysis of biomarkers and basophil activation test

+Outcome measures

Primary outcomes

Clarify mechanisms for anaphylaxis and establish biomarkers for this syndrome [2 days]: Immunological/nonimmunological mechanism

+Eligibility

Sex: All, ages: 16 Years to 120 Years, accepts healthy volunteers

Inclusion Criteria:

According to the specific cohort:

1. Diagnosis of anaphylaxis
2. Mild allergic reaction
3. Febrile transfusion reaction
4. Healthy, no known allergic disease

Exclusion Criteria:

Suspicion or diagnosed sepsis Children

+Locations (1)

Facility	City	Country	Status
Haukeland University Hospital	Bergen	Norway

+Investigators

Torunn O Apelseth, MD, PhD, Study director, Haukeland University Hospital
Morten Y Isaksen, MD, Principal investigator, Haukeland University Hospital