Trials Sponsors Conditions Drugs Pricing

Conditions

Hypersensitivity Reactions Iron-deficiency

Keywords

complement activation-related pseudoallergy (CARPA)Hypersensitivity reactions (HSR)iron-deficiencynon dextran iron preparations (NDIPs)anemia

Outcome Measures

Primary Outcomes (5)

previous medical history
Data collection (medical history) will be performed from patient records stored in the protected electronic patient system ISMed (Integrated System for Medical Diagnostic) of patients with HSRs to NDIPs
Baseline; Patients with HSRs to NDIPs that were treated at the University Hospital Basel between the 16th of January 2018 and the 24th of October 2019
Family history
Data collection (Family history) will be performed from patient records stored in the protected electronic patient system ISMed (Integrated System for Medical Diagnostic) of patients with HSRs to NDIPs
Baseline; Patients with HSRs to NDIPs that were treated at the University Hospital Basel between the 16th of January 2018 and the 24th of October 2019
assessment of hypersensitivity reactions
assessment of hypersensitivity reactions (grade I-IV) to Ferinject or Venofer
Baseline; Patients with HSRs to NDIPs that were treated at the University Hospital Basel between the 16th of January 2018 and the 24th of October 2019

Study Arms (1)

patients with hypersensitivity reactions to NDIPs

Patients with previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject) or to iron sucrose (Venofer)

Other: collection of patient data

Interventions

collection of patient dataOther

Data collection (history, clinical presentation, medication, complications, laboratory testing) will be performed from patient records stored in the protected electronic patient system ISMed (Integrated System for Medical Diagnostic) of patients with HSRs to NDIPs.

patients with hypersensitivity reactions to NDIPs

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age16 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Participants from 16 years of age and older with previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject) or to iron sucrose (Venofer).

You may qualify if:

Participants from 16 years of age and older with previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject) or to iron sucrose (Venofer).

Sponsors & Collaborators

University Hospital, Basel, Switzerland
Otherlead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

MeSH Terms

Conditions

Anemia, Iron-DeficiencyHypersensitivityAnemia

Condition Hierarchy (Ancestors)

Anemia, HypochromicHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesImmune System Diseases

Study Officials

Esther Steveling-Klein, Dr. med
Allergology, University Hospital Basel
PRINCIPAL INVESTIGATOR

Enrollment

42 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: RETROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 24, 2020

Study Start

September 1, 2019

Actual (reported)

Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Study Arms (1)

patients with hypersensitivity reactions to NDIPs

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Study Arms (1)

patients with hypersensitivity reactions to NDIPs

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations