임상연구정보서비스

Search: Search

Development of multi-center application model for prevention of contrast agent adverse reactions

Status Approved

First Submitted Date

2018/09/01
Registered Date

2018/09/21
Last Updated Date

2018/09/19

Move list page

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0003212
Unique Protocol ID	2018-0797
Public/Brief Title	Development and application of multi-center application model for prevention of contrast agent adverse reactions
Scientific Title	Development of multi-center application model for prevention of contrast agent adverse reactions
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status	Submitted approval

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2018-0797
Approval Date	2018-06-28
Institutional Review Board Name	Asan medical center institutional review board
Institutional Review Board Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul
Institutional Review Board Telephone	02-3010-7166
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Tae-Bum Kim
Title	Prof.
Telephone	+82-2-3010-3280
Affiliation	Asan Medical Center
Address	88, Olympic-ro 43-gil,Songpa-gu, Seoul 05505, Korea
Contact Person for Public Queries
Name	Ji-Hyang Lee
Title	Dr.
Telephone	+82-2-3010-1821
Affiliation	Asan Medical Center
Address	88, Olympic-ro 43-gil,Songpa-gu, Seoul 05505, Korea
Contact Person for Updating Information
Name	Ji-Hyang Lee
Title	Dr.
Telephone	+82-2-3010-1821
Affiliation	Asan Medical Center
Address	88, Olympic-ro 43-gil,Songpa-gu, Seoul 05505, Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 13
Overall Recruitment Status	Recruiting
Date of First Enrollment	2018-09-10 Actual
Target Number of Participant	200
Primary Completion Date	2020-12-31 , Anticipated
Study Completion Date	2020-12-31 , Anticipated
Name of Study	Asan Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2018-09-10 ,
Recruitment Status by Participating Study Site 2
Name of Study	Koera University Guro Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2018-09-28 ,
Recruitment Status by Participating Study Site 3
Name of Study	Samsung Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2018-09-28 ,
Recruitment Status by Participating Study Site 4
Name of Study	Yonsei University Health System, Severance Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2018-09-28 ,
Recruitment Status by Participating Study Site 5
Name of Study	Ajou University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2018-09-28 ,
Recruitment Status by Participating Study Site 6
Name of Study	Jeju National University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2018-09-28 ,
Recruitment Status by Participating Study Site 7
Name of Study	Hanyang University Seoul Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2018-09-28 ,
Recruitment Status by Participating Study Site 8
Name of Study	Seoul Metropolitan Government Seoul National University Boramae Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2018-09-28 ,
Recruitment Status by Participating Study Site 9
Name of Study	Seoul National University Bundang Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2018-09-28 ,
Recruitment Status by Participating Study Site 10
Name of Study	Pusan National University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2018-09-28 ,
Recruitment Status by Participating Study Site 11
Name of Study	Chonnam National University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2018-09-28 ,
Recruitment Status by Participating Study Site 12
Name of Study	Konkuk University Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2018-09-28 ,
Recruitment Status by Participating Study Site 13
Name of Study	Kyungpook National University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2018-09-28 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Ministry of Health & Welfare
Organization Type	Government
Project ID	HI18C1392

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Asan Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	With the incresed use of contrast enhanced CT scanning, hypersensitivity reaction to radiocontrast media (RCM) is a persistent clinical issue. RCM is one of the common causes of drug related adverse reactions and somtimes leads to lethal case. However, it is impossible so far to predict hypersensitivity reaction in advance. Moreover, there is no established guidline for the patients who experienced hypersensitivity reaction to RCM, when they plan re-exposure to the RCM. Increasing evidencs indicating underlying IgE mediated mechanism of hypersensitivity reaction to RCM resulted in several studies regarding skin testing. In our center, we analysed about 60 patients with history of hypersensitivity reaction to RCM. We found out that when the patients showed positive result in the skin test using culprit RCM, they tended to be safe when using other skin test negative RCM. When the skin test using culprit agent was negative, changing RCM regardless of the result of skin tests using other available RCM seemed sufficient to prevent hypersensitivity reactions. This previous study suggests new algorithm for selecting safe substitute in the previous reactors which should be validated through larger studty.

Study Summary Information

Lay Summary

With the incresed use of contrast enhanced CT scanning, hypersensitivity reaction to radiocontrast media (RCM) is a persistent clinical issue. RCM is one of the common causes of drug related adverse reactions and somtimes leads to lethal case. However, it is impossible so far to predict hypersensitivity reaction in advance. Moreover, there is no established guidline for the patients who experienced hypersensitivity reaction to RCM, when they plan re-exposure to the RCM.
 Increasing evidencs indicating underlying IgE mediated mechanism of hypersensitivity reaction to RCM resulted in several studies regarding skin testing.
 In our center, we analysed about 60 patients with history of hypersensitivity reaction to RCM. We found out that when the patients showed positive result in the skin test using culprit RCM, they tended to be safe when using other skin test negative RCM. When the skin test using culprit agent was negative, changing RCM regardless of the result of skin tests using other available RCM seemed sufficient to prevent hypersensitivity reactions.
 This previous study suggests new algorithm for selecting safe substitute in the previous reactors which should be validated through larger studty.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Prevention
Phase	Not applicable
Intervention Model	Single Group
Blinding/Masking	Open
Allocation	Not Applicable
Intervention Type	Others
Intervention Description	When the skin test is positive with culprit radiocontratmedia (RCM), an additional skin test with other radiocontrastmedia is performed to select a negative skin-test RCM as a safe substitute agent in the following exposure. If the skin test with culprit agent shows a negative result to the culprit RCM, causative RCM is changed to another one without additional skin test.
Number of Arms	1
Arm 1	Arm Label Algorithm applied for prevention of recurrent hypersensitivity reaction to radiocontrast media
	Target Number of Participant 200
	Arm Type Experimental
	Arm Description When the skin test is positive with culprit radiocontratmedia (RCM), an additional skin test with other radiocontrastmedia is performed to select a negative skin-test RCM as a safe substitute agent in the following exposure. If the skin test with culprit agent shows a negative result to the culprit RCM, causative RCM is changed to another one without additional skin test.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (S00-T98)Injury, poisoning and certain other consequences of external causes (T80.8)Other complications following infusion, transfusion and therapeutic injection
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~No Limit
	Description The patients who experienced hypersensitivity reactions to the radiocontrast media during CT scanning
Exclusion Criteria	1) Patients under age 18 2) Unstable vital signs 3) Dermographism 4) Pregnancy 5) Unknown radioncontrast media
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Occurence and severity of adverse reaction after changing radiocontrast media according to suggested algorithm
Timepoint	When the patients are re-exposed to the changed radiocontrast media
Secondary Outcome(s) 1
Outcome	Clinical difference between the patients according to the results of skin test using culprit radiocontrast media
Timepoint	When the patients undergo skin tesing using culprit radiocontrast media

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

Move list page Move to top