AnaphylaxisANAMEKNCT03182491
Mechanisms of Anaphylaxis
An observational study of Anaphylaxis and Allergy, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Anaphylaxis, Allergy, Transfusion Reaction
- What is being tested?
- Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 28 Apr 2017to 31 Dec 2028
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adults
Who may be able to join
- According to the specific cohort:
- Diagnosis of anaphylaxis
- Mild allergic reaction
- Febrile transfusion reaction
- Healthy, no known allergic disease
Who cannot join
- Suspicion or diagnosed sepsis Children
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)
- Keywords
- Platelet activating factor, Basophil activation test, Anaphylatoxins
- Medical subject headings
- Anaphylaxis, Hypersensitivity, Transfusion Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)Diagnostic test
Analysis of biomarkers and basophil activation test
| Study group | Role | What they receive |
|---|---|---|
| Anaphylaxis | Not described Receives: Diagnostic Test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT) | |
| Febrile transfusion reactions | Not described Receives: Diagnostic Test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT) | |
| Mild allergic reactions | Not described Receives: Diagnostic Test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT) | |
| Healthy controls | Not described Receives: Diagnostic Test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clarify mechanisms for anaphylaxis and establish biomarkers for this syndrome
Immunological/nonimmunological mechanism
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start28 Apr 2017
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torunn O Apelseth, MD, PhD, Study director, Haukeland University HospitalMorten Y Isaksen, MD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182491
- Sponsor's protocol ID
- 2016/1635
- Acronym
- ANAMEK
- Status last verified
- Oct 2026
- First submitted
- 7 Jun 2017
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Anaphylaxis
- ClinicalTrials.gov ID
- NCT03182491
- Acronym / sponsor ID
- ANAMEK / 2016/1635
- Keywords
- Platelet activating factor, Basophil activation test, Anaphylatoxins
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 16 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults
Key inclusion criteria (5 listed)
- Diagnosis of anaphylaxis
- Mild allergic reaction
- Febrile transfusion reaction
- Healthy, no known allergic disease
Key exclusion criteria (1 listed)
- Suspicion or diagnosed sepsis Children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)Analysis of biomarkers and basophil activation test | Diagnostic test | Anaphylaxis, Febrile transfusion reactions, Healthy controls, Mild allergic reactions |
Primary outcome
Clarify mechanisms for anaphylaxis and establish biomarkers for this syndrome
Time frame: 2 days
Immunological/nonimmunological mechanism
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torunn O Apelseth, MD, PhD study director
Haukeland University Hospital
Morten Y Isaksen, MD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaphylaxis and Allergy, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clarify mechanisms for anaphylaxis and establish biomarkers for this syndrome (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.