Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions

Iron-deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04359368
• Other study ID #: 2019-01266;sp20Steveling3
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: April 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Hypersensitivity
• Hypersensitivity Reactions
• Iron-deficiency

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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