Contrast Medium
Conditions
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.
Interventions
Patients who have received Iopromide (iodine concentrations of 300 mg/mL or 370 mg/mL) either intra-venously or intra-arterially.
Sponsors
Bayer
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with anaphylactoid reactions of Iopromide after administration | Retrospective analysis from 31 Aug 2010 to 30 Sep 2011 |
Secondary
| 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 |
Countries
Germany
Outcome results
None listed