None listed
Conditions
Interventions
Drug : In patients with a history of prior acute adverse drug reactions to gadolinium-based contrast agents, participants are randomized to either continuation of the contrast agent that caused the pr
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 to 80 years. 2. Patients with a history of GBCA-related adverse drug reactions, classified as mild or moderate according to Korean clinical practice guidelines 3. Patients who are able to provide relevant information, including the type of GBCA associated with the previous reaction and the type and severity of the previous GBCA-related ADR. 4. Patients with a medical indication for contrast-enhanced MRI.
Exclusion criteria
Exclusion criteria: 1. Patients who have experienced adverse reactions to two or more different GBCAs. 2. Patients whose previous GBCA-related adverse reaction was caused by gadoxetate disodium. 3. Patients who do not wish to receive premedication. 4. Patients who underwent contrast-enhanced CT or MRI within 24 hours before screening. 5. Patients for whom a specific GBCA has been designated by the Department of Allergy and Immunology. 6. Patients with a history of severe GBCA-related adverse reactions, including anaphylaxis, as defined by Korean clinical practice guidelines. 7. Patients requiring contrast agent administration through a central venous catheter.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate of adverse drug reactions in the GBCA-substitution group versus the re-exposure group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the severity distribution of recurrent GBCA-related adverse drug reactions between the GBCA-switching and re-exposure groups;Association between the severity of previous GBCA-related ADRs and the severity of recurrent ADRs | — |
Countries
Korea, Republic of
Contacts
Public ContactSeo Rin Choi
Asan Medical Center
Outcome results
None listed