Study on the Risk of Allergy-like Reactions After Intra-arterial or Intra-venous Injection of the Marketed X-ray Contrast Medium Iopromid

Completed

• Conditions: Contrast Medium
• Interventions: Drug: Iopromide (Ultravist, BAY86-4877)

• Registration Number: NCT03622801
• Lead Sponsor: Bayer

Brief Summary

Iopromide (trade name is Ultravist) is on the market for more than 30 years and has been used more than 250 million times as X-ray contrast medium for patients. It is known that Iopromide may cause allergy-like reactions after being injected. With this study researchers want to find out, if the risk of severe allergy-like reactions is lower, when Iopromide will be injected into an artery, compared to the risk after an injection of Iopromid into a vein. To find this out data from four trials on Iopromide that are already completed will be combined and newly analyzed. The database used for this analysis will contain data from more than 150,000 patients.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-09
• Study Start: 2018-10-12
• Primary Completion: 2019-02-14
• Study Completion: 2019-02-14
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-14
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133331

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intravenous administration	Iopromide (Ultravist, BAY86-4877)	Patients with intravenous administration of Iopromide
Intra-arterial administration	Iopromide (Ultravist, BAY86-4877)	Patients with intra-arterial administration of Iopromide

Primary Outcome Measures

Name	Time	Method
Number of patients with anaphylactoid reactions of Iopromide after administration	Retrospective analysis from 31 Aug 2010 to 30 Sep 2011

Secondary Outcome Measures

Name	Time	Method
Number of patients with anaphylactoid reactions after intra-venous administration of Iopromide	Retrospective analysis from 31 Aug 2010 to 30 Sep 2011
Number of patients with anaphylactoid reactions after intra-arterial administration of Iopromide	Retrospective analysis from 31 Aug 2010 to 30 Sep 2011

Trial Locations

Locations (1)

Many Locations; 🇩🇪 Multiple Locations, Germany