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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042151
Receipt No. 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

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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
Email 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
Email hotta.naoshi.18@ncvc.go.jp

Sponsor
Institute National cerebral and cardiovascular center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048113

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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