Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions

Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions - a Retrospective Study

This study aims to evaluate characteristics of patients with previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject) or to iron sucrose (Venofer) including age, atopy status, previous allergic reactions, previous medical history, current medications and co-morbidities. Furthermore, symptoms on reaction such as severity grade of reaction will be evaluated.

Study Overview

• Status: Completed
• Conditions: Iron-deficiency; Hypersensitivity Reactions
• Intervention / Treatment: Other: collection of patient data

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability 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).

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• No previous hypersensitivity reaction to iron preparations or reactions to oral iron preparations.
• If a rejection to use patient data is documented in patient records, the patient will be excluded from analysis.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
preparation used	which preparation was used for Treatment ( iron sucrose (Venofer) or ferric carboxymaltose (Ferinject)	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
co-medication	which co-medication was used	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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Esther Steveling-Klein, Dr. med, Allergology, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ACTUAL): October 31, 2019
• Study Completion (ACTUAL): October 31, 2019

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (ACTUAL): April 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 21, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: anemia; iron-deficiency; complement activation-related pseudoallergy (CARPA); Hypersensitivity reactions (HSR); non dextran iron preparations (NDIPs)
• Additional Relevant MeSH Terms: Metabolic Diseases; Immune System Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Hypersensitivity; Anemia, Iron-Deficiency
• Other Study ID Numbers: 2019-01266;sp20Steveling3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No