UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036427 |
|---|---|
| Receipt number | R000041495 |
| Scientific Title | Hemolysis in patients with post aortic stenosis treatment evaluated by erythrocyte creatine -Comparison of surgical aortic valve replacement and transcatheter aortic valve implantation- |
| Date of disclosure of the study information | 2019/05/07 |
| Last modified on | 2020/04/06 09:29:04 |
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Basic information
Public title
Hemolysis in patients with post aortic stenosis treatment evaluated by erythrocyte creatine
-Comparison of surgical aortic valve replacement and transcatheter aortic valve implantation-
Acronym
Difference of hemolysis in patients with surgical and transcatheter aortic stenosis treatment
Scientific Title
Hemolysis in patients with post aortic stenosis treatment evaluated by erythrocyte creatine
-Comparison of surgical aortic valve replacement and transcatheter aortic valve implantation-
Scientific Title:Acronym
Difference of hemolysis in patients with surgical and transcatheter aortic stenosis treatment
Region
| Japan |
Condition
Condition
Aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of hemolysis in patients with surgical aortic valve replacement and transcatheter aortic valve implantation
Basic objectives2
Others
Basic objectives -Others
Elucidation of mechanism
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of hemolysis in patients with surgical aortic valve replacement and transcatheter aortic valve implantation
Key secondary outcomes
Comparison between pre and post treatment in patients with surgical aortic valve replacement or transcatheter aortic valve implantation
Long-term cardiovascular outcome and hemolysis
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Scheduled surgical aortic valve replacement or transcatheter aortic valve implantation in patients with severe aortic stenosis
Key exclusion criteria
Already received surgical treatment for either cardiac valve disease
Required transfusion preoperative period
Patients with autoimmune hemolytic anemia
Patients with malignant tumor
Patients who received regular dialysis
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Matsumura |
Organization
Kansai Medical University Medical Center
Division name
Department of Cardiology
Zip code
570-8507
Address
10-15, Fumizono-cho, Moriguchi, Osaka Japan
TEL
+81-6-6992-1001
kmatsumura1980@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shinobu |
| Middle name | |
| Last name | Bandou |
Organization
Kansai Medical University Medical Center
Division name
Department of Cardiology
Zip code
570-8507
Address
10-15, Fumizono-cho, Moriguchi, Osaka Japan
TEL
+81-6-6992-1001
Homepage URL
bandoshi@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Medical Center
Address
10-15, Fumizono-cho, Moriguchi, Osaka Japan
Tel
+81-6-6992-1001
bandoshi@takii.kmu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
0
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2019 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2019 | Year | 04 | Month | 06 | Day |
Last modified on
| 2020 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041495
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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