Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions

Completed

• Conditions: Hypersensitivity Reactions; Iron-deficiency
• Interventions: Other: collection of patient data

• Registration Number: NCT04359368
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Status Verified: 2020-04
• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-21
• Last Update Submitted: 2020-04-21
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with hypersensitivity reactions to NDIPs	collection of patient data	Patients with previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject) or to iron sucrose (Venofer)

Primary Outcome Measures

Name	Time	Method
Family history	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	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
previous medical history	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	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
assessment of hypersensitivity reactions	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 (grade I-IV) to Ferinject or Venofer
co-medication	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	which co-medication was used
preparation 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	which preparation was used for Treatment ( iron sucrose (Venofer) or ferric carboxymaltose (Ferinject)

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland