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

Bayer

Status: Completed

Conditions: Contrast Medium

Treatments: Drug: Iopromide (Ultravist, BAY86-4877)

Study type: Observational

Funder types: Industry

Identifiers

NCT03622801

19677

Details and patient eligibility

About

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.

Enrollment: 133,331 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

133,331 participants in 2 patient groups

Intra-arterial administration

Description:

Patients with intra-arterial administration of Iopromide

Treatment:

Drug: Iopromide (Ultravist, BAY86-4877)

Intravenous administration

Description:

Patients with intravenous administration of Iopromide

Treatment:

Drug: Iopromide (Ultravist, BAY86-4877)