Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions

NCT04359368 | Completed

• 1 other identifier: 2019-01266;sp20Steveling3
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron-deficiency; Hypersensitivity Reactions

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

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

Interventions

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.

patients with hypersensitivity reactions to NDIPs

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Hypersensitivity; Anemia

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Immune System Diseases

Study Officials

• Esther Steveling-Klein, Dr. med

  Allergology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: September 1, 2019
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

CH (1)