UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046891 |
|---|---|
| Receipt number | R000053500 |
| Scientific Title | Intravascular Hemolysis After Transcatheter Aortic Valve Implantation in patients with Severe Aortic Stenosis: Observational, multicenter, prospective study |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2024/08/18 19:43:32 |
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Basic information
Public title
Intravascular Hemolysis After Transcatheter Aortic Valve Implantation in patients with Severe Aortic Stenosis: Observational, multicenter, prospective study
Acronym
Intravascular Hemolysis After TAVI
Scientific Title
Intravascular Hemolysis After Transcatheter Aortic Valve Implantation in patients with Severe Aortic Stenosis: Observational, multicenter, prospective study
Scientific Title:Acronym
Intravascular Hemolysis After TAVI
Region
| Japan |
Condition
Condition
Severe Aortic Stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate frequency and significance of intravascular hemolysis after transcatheter aortic valve implantation.
Basic objectives2
Others
Basic objectives -Others
Clinical outcome for one year after transcatheter aortic valve implantation
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
The frequency of the patients with intravascular hemolysis for one year after transcatheter aortic valve implantation
Key secondary outcomes
The frequency of cardiovascular readmission and cardiovascular death at one year in patients with intravascular hemolysis after transcatheter aortic valve implantation
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
1. Patients who underwent transcatheter aortic valve implantation
2. Patients with over 20 years old
3. Patients who agree to be enrolled for the trial gave signed written informed consent
Key exclusion criteria
Any patients who are judged inappropriate by research director or co-investigators
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Otake |
Organization
Kobe University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
0783825846
hotake@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kawamori |
Organization
Kobe University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
0783825846
Homepage URL
https://www.med.kobe-u.ac.jp/im1/index.html
hiroyuki@med.kobe-u.ac.jp
Sponsor or person
Institute
The department of Cardiovascular Medicine at Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Clinical and Translational Research Center, Kobe University Hospital
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017
Tel
078-382-5400
kansatsu@med.kobe-u.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
加古川中央市民病院 Kakogawa City Hospital
兵庫県立はりま姫路総合医療センター Hyogo Prefectural Harima-Himeji General Medical Center
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 01 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 02 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Elevated serum LDH was the primary variable used for determining the presence or absence of hemolysis (>222IU/L), in addition to at least 2 minor criteria that included low hemoglobin values (<13.8 g/dL for men or <12.4 g/dL for women), low haptoglobin values (<19 mg/dL), high percentage of reticulocytes (>2%), or presence of schisto-cytes in the peripheral blood smear.
Management information
Registered date
| 2022 | Year | 02 | Month | 12 | Day |
Last modified on
| 2024 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053500
