Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions

NCT ID: NCT04359368

Last Updated: 2020-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2019-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Iron-deficiency Hypersensitivity Reactions

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients with hypersensitivity reactions to NDIPs

Patients with previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject) or to iron sucrose (Venofer)

collection of patient data

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Esther Steveling-Klein, Dr. med

Role: PRINCIPAL_INVESTIGATOR

Allergology, University Hospital Basel

Locations

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University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2019-01266;sp20Steveling3

Identifier Type: -

Identifier Source: org_study_id

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