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
1 other identifier
observational
133,331
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2018
CompletedFirst Posted
Study publicly available on registry
August 9, 2018
CompletedStudy Start
First participant enrolled
October 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2019
CompletedFebruary 17, 2020
February 1, 2020
4 months
August 6, 2018
February 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with anaphylactoid reactions of Iopromide after administration
Retrospective analysis from 31 Aug 2010 to 30 Sep 2011
Secondary Outcomes (2)
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
Study Arms (2)
Intra-arterial administration
Patients with intra-arterial administration of Iopromide
Intravenous administration
Patients with intravenous administration of Iopromide
Interventions
Patients who have received Iopromide (iodine concentrations of 300 mg/mL or 370 mg/mL) either intra-venously or intra-arterially.
Eligibility 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.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Many Locations
Multiple Locations, Germany
MeSH Terms
Interventions
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2018
First Posted
August 9, 2018
Study Start
October 12, 2018
Primary Completion
February 14, 2019
Study Completion
February 14, 2019
Last Updated
February 17, 2020
Record last verified: 2020-02