UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027761 |
|---|---|
| Receipt number | R000031812 |
| Scientific Title | Establishment of prediction and prevention method for bleeding complication after left ventricular assist device implantation |
| Date of disclosure of the study information | 2017/06/14 |
| Last modified on | 2023/10/11 18:12:12 |
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Basic information
Public title
Establishment of prediction and prevention method for bleeding complication after left ventricular assist device implantation
Acronym
LVADAVWS Study
Scientific Title
Establishment of prediction and prevention method for bleeding complication after left ventricular assist device implantation
Scientific Title:Acronym
LVADAVWS Study
Region
| Japan |
Condition
Condition
Patients with LVAD
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between bleeding complication and aquired von Willebrand syndrome, platelet surface protein and platelet aggregation test after LVAD implantation, and to establish evidence for the creation of guidelines.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VWF multimer analysis, platelet surface protein analysis and platelet aggregation test are performed on the blood sample before and after LVAD implantation.
Key secondary outcomes
We acquire clinical data before and after LVAD implantation from the database of J-MACS registry.
Specific datas are as follows.
1) Medical history, diagnosis
2) Electrocardiogram
3) Blood sampling test
4) Echocardiography
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
| 1 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases after LVAD implantation
Key exclusion criteria
None.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshikatsu |
| Middle name | |
| Last name | Saiki |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Cardiovascular Surgery
Zip code
9808574
Address
1-1 Seiryocho, Aoba-ku, Sendai, 980-8574 Japan
TEL
022-717-7222
yoshisaiki@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Ko |
| Middle name | |
| Last name | Sakatsume |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Cardiovascular Surgery
Zip code
980-8574
Address
1-1 Seiryocho, Aoba-ku, Sendai, 980-8574 Japan
TEL
022-717-7222
Homepage URL
kosakatsume@gmail.com
Sponsor or person
Institute
Tohoku University Graduate School of Medicine,Division of Cardiovascular Surgery
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Tohoku University Graduate School of Medicine
Address
1-1 Seiryocho, Aoba-ku, Sendai, 980-8574 Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2017 | Year | 06 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None.
Management information
Registered date
| 2017 | Year | 06 | Month | 14 | Day |
Last modified on
| 2023 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031812
