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
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
-
-
-
Bergen, Norway
- Haukeland University Hospital
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-
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:
- Diagnosis of anaphylaxis
- Mild allergic reaction
- Febrile transfusion reaction
- 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
|
Analysis of biomarkers and basophil activation test
|
|
Anaphylaxis
|
Analysis of biomarkers and basophil activation test
|
|
Febrile transfusion reactions
|
Analysis of biomarkers and basophil activation test
|
|
Mild allergic reactions
|
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
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
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.