Active, not recruitingNCT03182491ANAMEKUpdated Aug 3, 2022

Mechanisms of Anaphylaxis

An observational study in Anaphylaxis, Allergy and Transfusion Reaction, sponsored by Haukeland University Hospital. Active, not recruiting at 1 site in Norway. Open to participants aged 16 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-03.

Sponsored by Haukeland University Hospital · Observational

Study type: Observational
Model: Other
Time perspective: Prospective
Enrollment: 40
Ages: 16 Years to 120 Years
Sex: All

Study 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.

Conditions studied

Anaphylaxis
Allergy
Transfusion Reaction
Febrile Transfusion Reaction

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Keywords

Platelet activating factor
Basophil activation test
Anaphylatoxins

Who can participate

Ages eligible: 16 Years to 120 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

Adults

Inclusion criteria

According to the specific cohort:

Diagnosis of anaphylaxis
Mild allergic reaction
Febrile transfusion reaction
Healthy, no known allergic disease

Exclusion criteria

Exclusion Criteria:

Suspicion or diagnosed sepsis Children

Study design

Observational model: Other
Time perspective: Prospective
Enrollment: 40 participants (estimated)
Target follow-up: 2 Days
Patient registry: Yes
Biospecimen retention: Samples with dna

Groups and cohorts

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)

Interventions

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

What researchers measure

Primary outcomes

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

Study locations

1 site

Haukeland University Hospital
Bergen, Norway

Registry details

Key details

Study ID: NCT03182491
Lead sponsor: Haukeland University Hospital
Responsible party: Sponsor
First posted: Jun 9, 2017
Start date: Apr 28, 2017
Primary completion: Oct 1, 2026 (estimated)
Completion: Oct 1, 2026 (estimated)
Last update: Aug 3, 2022

Study contacts

Torunn O Apelseth, MD, PhD

study director · Haukeland University Hospital

Morten Y Isaksen, MD

principal investigator · Haukeland University Hospital

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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