UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031073 |
|---|---|
| Receipt number | R000035445 |
| Scientific Title | Research of a leukocyte and platelet dysfunction causing by cardiopulmonary bypass |
| Date of disclosure of the study information | 2018/01/31 |
| Last modified on | 2025/08/07 09:35:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research of a leukocyte and platelet dysfunction causing by cardiopulmonary bypass
Acronym
Research of a leukocyte and platelet dysfunction causing by cardiopulmonary bypass
Scientific Title
Research of a leukocyte and platelet dysfunction causing by cardiopulmonary bypass
Scientific Title:Acronym
Research of a leukocyte and platelet dysfunction causing by cardiopulmonary bypass
Region
| Japan |
Condition
Condition
cardiovascular disease
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A platelet and leukocyte dysfunction occur in a cardiopulmonary bypass and hypothermia by a cardiovascular surgery. In this study, we measure a mitochondrial respiratory function of a platelet and a leukocyte.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oxygen consumption of a mitochondria
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 undergoing scheduled cardiovascular surgery using cardioplumonary bypass
Key exclusion criteria
platelet less than 10000
platelet transfusion during study duration
pregnant
patient with blood disease
patient with a past of mitochondria disease
patient with severe electrolyte abnormality
patient with severe endcrine disease
patient with severe liver dysfunction
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | itabashi toshio |
Organization
tokyo medical university
Division name
anesthesiology
Zip code
Address
6-7-1,nishi-sinjuku,sinjuku,tokyo
TEL
03-3342-6111
itabashi@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | itabashi toshio |
Organization
tokyo medical university
Division name
anesthesiology
Zip code
Address
6-7-1,nishi-sinjuku,sinjuku,tokyo
TEL
03-3342-6111
Homepage URL
itabashi@tokyo-med.ac.jp
Sponsor or person
Institute
tokyo medical university
Institute
Department
Personal name
Funding Source
Organization
japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 01 | Month | 31 | 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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 01 | Day |
Other
Other related information
not in particular
Management information
Registered date
| 2018 | Year | 01 | Month | 31 | Day |
Last modified on
| 2025 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035445
