NCT03622801

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

Risk of Anaphylactoid Reactions of Iopromide After Intra-arterial Administration

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 133,331 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Contrast Medium

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-10-12
• Primary completion: 2019-02-14
• Completion: 2019-02-14
• First posted: 2018-08-09
• Last updated: 2020-02-17

Locations

1 site across 1 country: Germany