NCT03525496

Brief Summary

Iodinated contrast agents (ICA) are widely used in medical imaging. They provide however a risk of immediate hypersensitivity reactions (IHS). The risk of anaphylactic shock is estimated at 1/100 000 injections. Nevertheless, for safety reasons and to limit undesirable effects, the reintroduction tests are not conducted along similar lines to throughout scan or arteriography. Moreover, reintroduction protocols are actually not standardized, in terms of injected volume and doses progression. It should be evaluated the relevance of the reintroduction tests with injection of a low volume and ensure the absence of reaction during the ICA injections Under real conditions. The investigators are assuming that the realization of a provocation test by intravenous reintroduction with a reduced dose of ICA improves the predictive value of IHS in comparison with only cutaneous tests.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

May 4, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 15, 2018

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

September 24, 2018

Status Verified

April 1, 2018

Enrollment Period

28 days

First QC Date

April 24, 2018

Last Update Submit

September 20, 2018

Conditions

Allergic Reaction

Keywords

Iodinated contrast agentsImmediate hypersensitivity reactionsReintroduction tests

Outcome Measures

Primary Outcomes (1)

  • Percentage of immediate hypersensitivity reactions

    Occurrence of immediate hypersensitivity reactions after an injection of ICA

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Major patient who had an iodinated contrast agents reintroduction test

You may qualify if:

  • Major patient
  • Having suffered single-blind reintroduction
  • Having benefited from cutaneous tests and ICA reintroduction test in the framework of IHS

You may not qualify if:

  • Patient with delayed hypersensitivity
  • Opposed to use data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Metz-Thionville

Metz, Moselle, 57085, France

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2018

First Posted

May 15, 2018

Study Start

May 4, 2018

Primary Completion

June 1, 2018

Study Completion

August 1, 2018

Last Updated

September 24, 2018

Record last verified: 2018-04

Locations

FR(1)