Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions

Study Overview
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Brief Summary
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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.

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

Conditions
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Iron-deficiency, Hypersensitivity Reactions

Intervention / Treatment
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* Other: collection of patient data


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with hypersensitivity reactions to NDIPs<br>Patients with previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject) or to iron sucrose (Venofer) | Other: collection of patient data<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complement activation-related pseudoallergy (CARPA), Hypersensitivity reactions (HSR), iron-deficiency, non dextran iron preparations (NDIPs), anemia