Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT04359368

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

21.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Iron-deficiency Hypersensitivity Reactions	Other: collection of patient data

Study Design

Study Type:

Observational

Actual Enrollment :

42 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2019

Actual Primary Completion Date :

Oct 31, 2019

Actual Study Completion Date :

Oct 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
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 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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

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
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
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
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)
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.