Mechanisms of Anaphylaxis (ANAMEK)

August 2, 2022 updated by: Haukeland University Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway
        • Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy controls
Diagnostic test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)
Analysis of biomarkers and basophil activation test
Anaphylaxis
Diagnostic test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)
Analysis of biomarkers and basophil activation test
Febrile transfusion reactions
Diagnostic test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)
Analysis of biomarkers and basophil activation test
Mild allergic reactions
Diagnostic test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)
Analysis of biomarkers and basophil activation test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clarify mechanisms for anaphylaxis and establish biomarkers for this syndrome
Time Frame: 2 days
Immunological/nonimmunological mechanism
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Investigators

  • Study Director: Torunn O Apelseth, MD, PhD, Haukeland University Hospital
  • Principal Investigator: Morten Y Isaksen, MD, Haukeland University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2017

Primary Completion (Anticipated)

October 1, 2026

Study Completion (Anticipated)

October 1, 2026

Study Registration Dates

First Submitted

June 7, 2017

First Submitted That Met QC Criteria

June 7, 2017

First Posted (Actual)

June 9, 2017

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/1635

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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