UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043199 |
|---|---|
| Receipt number | R000048479 |
| Scientific Title | A prospective observational study of the effects of various valves on coagulation factors and platelet function after transcatheter aortic valve replacement |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2021/08/03 17:21:19 |
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Basic information
Public title
A prospective observational study of the effects of various valves on coagulation factors and platelet function after transcatheter aortic valve replacement
Acronym
A prospective observational study of the effects of various valves on coagulation factors and platelet function after transcatheter aortic valve replacement
Scientific Title
A prospective observational study of the effects of various valves on coagulation factors and platelet function after transcatheter aortic valve replacement
Scientific Title:Acronym
A prospective observational study of the effects of various valves on coagulation factors and platelet function after transcatheter aortic valve replacement
Region
| Japan |
Condition
Condition
Severe aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of various valves on coagulation factors and platelet function before and after TAVI.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
R(min)<TEG6s> [Evaluation of coagulation factors]
MA(min)<TEG6s> [Evaluation of platelet function]
Key secondary outcomes
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
Patients diagnosed with aortic stenosis and undergoing transcatheter aortic valve implantation using The Edwards Lifesciences' SAPIEN3 or The Medtronic's Evolute-R at Teikyo University hospital
Key exclusion criteria
1) Patients who did not consent to participate in this study
2) Cases converted to open heart surgery during TAVI
3) Cases of massive bleeding during surgery
4) Perioperative Fresh frozen plasma or platelet transfusion
5) Non elective surgery
6) Cases where the planned valves were suddenly changed
7) Recognized coagulation system disorders before enrollment
8) TAVI with approaches other than Trans-Femoral
9) Cases with other severe valve diseases
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takeyuki |
| Middle name | |
| Last name | Sajima |
Organization
Teikyo University Hospital
Division name
Department of Anesthesiology
Zip code
173-8606
Address
2-11-1 Kaga, Itabashi-Ku, Tokyo
TEL
03-3964-1211
sajitake0331@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takeyuki |
| Middle name | |
| Last name | Sajima |
Organization
Teikyo University Hospital
Division name
Department of Anesthesiology
Zip code
173-8606
Address
2-11-1 Kaga, Itabashi-Ku, Tokyo
TEL
03-3964-1211
Homepage URL
sajitake0331@yahoo.co.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Teikyo University Ethical Review Board for Medical and Health Research Involving Human Subjects
Address
2-11-1 Kaga, Itabashi-Ku, Tokyo
Tel
03-3964-7256
turb-office@teikyo-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 08 | Month | 31 | Day |
Other
Other related information
We compare the effects of various valves (The Edwards Lifesciences' SAPIEN3 or The Medtronic's Evolute-R) on coagulation factors and platelet function before and after TAVI.
Management information
Registered date
| 2021 | Year | 02 | Month | 01 | Day |
Last modified on
| 2021 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048479
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
