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

Risk of Anaphylactoid Reactions of Iopromide After Intra-arterial Administration

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.

Study Overview

• Status: Completed
• Conditions: Contrast Medium
• Intervention / Treatment: Drug: Iopromide (Ultravist, BAY86-4877)

• Study Type: Observational
• Enrollment (Actual): 133331

Contacts and Locations

Study Locations

• Germany
  • Multiple Locations, Germany
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients who received a contrast enhanced x-ray examination with Iopromide for various clinical reasons. Iopromide was administered either intra-venously or intra-arterially.

Description

The study population consists of patients who received a contrast enhanced x-ray examination with Iopromide for various clinical reasons. Iopromide was administered either intra-venously or intra-arterially.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intra-arterial administration; Patients with intra-arterial administration of Iopromide	Drug: Iopromide (Ultravist, BAY86-4877); Patients who have received Iopromide (iodine concentrations of 300 mg/mL or 370 mg/mL) either intra-venously or intra-arterially.
Intravenous administration; Patients with intravenous administration of Iopromide	Drug: Iopromide (Ultravist, BAY86-4877); Patients who have received Iopromide (iodine concentrations of 300 mg/mL or 370 mg/mL) either intra-venously or intra-arterially.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2018
• Primary Completion (Actual): February 14, 2019
• Study Completion (Actual): February 14, 2019

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 14, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 19677

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No