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Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04359368
Enrollment
42
Registered
2020-04-24
Start date
2019-09-01
Completion date
2019-10-31
Last updated
2020-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypersensitivity Reactions, Iron-deficiency

Keywords

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

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.

Interventions

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.

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
previous medical historyBaseline; Patients with HSRs to NDIPs that were treated at the University Hospital Basel between the 16th of January 2018 and the 24th of October 2019Data 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
Family historyBaseline; Patients with HSRs to NDIPs that were treated at the University Hospital Basel between the 16th of January 2018 and the 24th of October 2019Data 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
assessment of hypersensitivity reactionsBaseline; Patients with HSRs to NDIPs that were treated at the University Hospital Basel between the 16th of January 2018 and the 24th of October 2019assessment of hypersensitivity reactions (grade I-IV) to Ferinject or Venofer
preparation usedBaseline; Patients with HSRs to NDIPs that were treated at the University Hospital Basel between the 16th of January 2018 and the 24th of October 2019which preparation was used for Treatment ( iron sucrose (Venofer) or ferric carboxymaltose (Ferinject)
co-medicationBaseline; Patients with HSRs to NDIPs that were treated at the University Hospital Basel between the 16th of January 2018 and the 24th of October 2019which co-medication was used

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026