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Completed

NCT Number: NCT04359368

Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions

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.

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Key information

Conditions

Iron-deficiency Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity Reactions Immune System Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

collection of patient data

Other

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.

Primary outcomes

  1. previous medical history

    Time frame: 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

  2. Family history

    Time frame: 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

  3. assessment of hypersensitivity reactions

    Time frame: 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

  4. preparation used

    Time frame: 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)

  5. co-medication

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2020
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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