NCT03182491

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
Apr 2017Oct 2026

Study Start

First participant enrolled

April 28, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

9.4 years

First QC Date

June 7, 2017

Last Update Submit

August 2, 2022

Conditions

AnaphylaxisAllergyTransfusion ReactionFebrile Transfusion Reaction

Keywords

Platelet activating factorBasophil activation testAnaphylatoxins

Outcome Measures

Primary Outcomes (1)

  • Clarify mechanisms for anaphylaxis and establish biomarkers for this syndrome

    Immunological/nonimmunological mechanism

    2 days

Study Arms (4)

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

Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)DIAGNOSTIC_TEST

Analysis of biomarkers and basophil activation test

AnaphylaxisFebrile transfusion reactionsHealthy controlsMild allergic reactions

Eligibility Criteria

Age16 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults

You may qualify if:

  • According to the specific cohort:
  • Diagnosis of anaphylaxis
  • Mild allergic reaction
  • Febrile transfusion reaction
  • Healthy, no known allergic disease

You may not qualify if:

  • Suspicion or diagnosed sepsis Children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples, plasma samples, full blood-samples

MeSH Terms

Conditions

AnaphylaxisHypersensitivityTransfusion Reaction

Interventions

Basophil Degranulation Test

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateImmune System DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Officials

  • Torunn O Apelseth, MD, PhD

    Haukeland University Hospital

    STUDY DIRECTOR

  • Morten Y Isaksen, MD

    Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2017

First Posted

June 9, 2017

Study Start

April 28, 2017

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

August 3, 2022

Record last verified: 2022-08

Locations

NO(1)