UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000048113