UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042151 |
|---|---|
| Receipt number | R000048113 |
| Scientific Title | Investigation of the relationship between changes in peripheral blood biomarkers and delirium by cardiovascular surgery |
| Date of disclosure of the study information | 2020/10/20 |
| Last modified on | 2021/05/09 10:41:44 |
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Basic information
Public title
Investigation of the relationship between changes in peripheral blood biomarkers and delirium by cardiovascular surgery
Acronym
Investigation of the relationship between changes in peripheral blood biomarkers and delirium by cardiovascular surgery
Scientific Title
Investigation of the relationship between changes in peripheral blood biomarkers and delirium by cardiovascular surgery
Scientific Title:Acronym
Investigation of the relationship between changes in peripheral blood biomarkers and delirium by cardiovascular surgery
Region
| Japan |
Condition
Condition
cardiovascular surgery
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between BBB disruption and the perioperative change in the amount of neuron-derived exosomes isolated from venous blood in the patients who received cardiovascular surgery with/without CPB.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The perioperative change in the amount of neuron-derived exosomes isolated from venous blood
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
| 65 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Adult patients in cardiovascular surgery with/without CPB
- Normal preoperative cognitive function
- Normal renal/liver function
- Non-obese patients (body mass index, <35 kg/m2)
Key exclusion criteria
- Patients with perioperative renal dysfunction with anuria were excluded
- Blood samples were not collected correctly
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Yoshitani |
Organization
National cerebral and cardiovascular center
Division name
Department of Transfusion
Zip code
5648565
Address
6-1, Kishibeshimmachi, Suita, Osaka
TEL
0661701070
ykenji@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Naoshi |
| Middle name | |
| Last name | Hotta |
Organization
National cerebral and cardiovascular center
Division name
Department of Anesthesiology
Zip code
5648565
Address
6-1, Kishibeshimmachi, Suita, Osaka
TEL
0661701070
Homepage URL
hotta.naoshi.18@ncvc.go.jp
Sponsor or person
Institute
National cerebral and cardiovascular center
Institute
Department
Personal name
Funding Source
Organization
National cerebral and cardiovascular center
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
National cerebral cardiovascular center
Address
6-1, Kishibeshimmachi, Suita, Osaka
Tel
0661701070
rec-office-ac@ncvc.go.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
| 2020 | Year | 10 | Month | 20 | 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
| 2020 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Informations of patient characters, operation and anesthesia.
Management information
Registered date
| 2020 | Year | 10 | Month | 18 | Day |
Last modified on
| 2021 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048113
| Research Plan | |
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| 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 |
