ANAMEK: Mechanisms of Anaphylaxis

• Sponsor: Haukeland University Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03182491
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 113.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anaphylaxis; Allergy; Transfusion Reaction; Febrile Transfusion Reaction	Diagnostic Test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 40 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Mechanisms of Anaphylaxis
• Actual Study Start Date: Apr 28, 2017
• Anticipated Primary Completion Date: Oct 1, 2026
• Anticipated Study Completion Date: Oct 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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
Healthy controls	Diagnostic Test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT); Analysis of biomarkers and basophil activation test

Outcome Measures

Primary Outcome Measures

1. Clarify mechanisms for anaphylaxis and establish biomarkers for this syndrome [2 days]

   Immunological/nonimmunological mechanism

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haukeland University Hospital	Bergen		Norway

Sponsors and Collaborators

• Haukeland University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haukeland University Hospital
• ClinicalTrials.gov Identifier: NCT03182491
• Other Study ID Numbers: 2016/1635
• First Posted: Jun 9, 2017
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Haukeland University Hospital: Platelet activating factor; Basophil activation test; Anaphylatoxins
• Additional relevant MeSH terms: Transfusion Reaction; Anaphylaxis; Shock; Anaphylatoxins

Study Results

No Results Posted as of Aug 3, 2022