check_circleStudy Completed

Contrast medium

Bayer Identifier:

19677

ClinicalTrials.gov Identifier:

NCT03622801

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study on the risk of allergy-like reactions after intra-arterial or intra-venous injection of the marketed X-ray contrast medium Iopromid

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • 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 summary

Enrollment Goal
133331
Trial Dates
October 2018 - February 2019
Phase
Phase 4
Could I Receive a placebo
No
Products
Ultravist (Iopromide, BAY86-4877)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Germany

Primary Outcome

  • Number of patients with anaphylactoid reactions of Iopromide after administration
    date_rangeTime Frame:
    Retrospective analysis from 31 Aug 2010 to 30 Sep 2011

Secondary Outcome

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

Trial design

Risk of anaphylactoid reactions of Iopromide after intra-arterial administration
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A