UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of changes in cerebral circulation in the palliative surgery for congenital heart disease
Acronym	Changes in cerebral circulation in the palliative surgery for congenital heart disease
Scientific Title	Changes in cerebral blood flow indices by transcranial doppler and cerebral oxygenation by near infrared spectroscopy in pediatric palliative cardiac surgery
Scientific Title:Acronym	Changes in cerebral blood flow indices and oxygenation in pediatric palliative cardiac surgery
Region	Japan

Condition
Condition	congenital heart disease
Classification by specialty	Anesthesiology Cardiovascular surgery Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the changes in cerebral blood flow indices by transcranial doppler and cerebral oxygenation by near infrared spectroscopy in pediatric palliative cardiac surgery
Basic objectives2	Others
Basic objectives -Others	search of physiological changes
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in cerebral blood flow indices by transcranial doppler in pediatric palliative cardiac surgery
Key secondary outcomes	changes in cerebral oxygenation by near infrared spectroscopy in pediatric palliative cardiac surgery

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 days-old <=
Age-upper limit	6 years-old >
Gender	Male and Female
Key inclusion criteria	The patients that underwent pediatric palliative cardiac surgery from August 10, 2017 to December 31, 2020 and agreed to attend the clinical observational prospective study "evaluation of cerebral circulation in pediatric cardiac surgery using transcranial doppler and near infrared spetroscopy "(No 016-0505) by written informed consent.
Key exclusion criteria	1 the patients with intracranial disorders 2 the patients who refuse the attendance of the study after optout
Target sample size	43

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Morimoto
Organization	Hokkaido university hospital
Division name	Department of Anesthesiology
Zip code	0608648
Address	N14 W5, Kita-ku, Sapporo
TEL	0117161161
Email	morim2@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Yuji Middle name Last name Morimoto
Organization	Hokkaido university hospital
Division name	Department of Anesthesiology
Zip code	0608648
Address	N14 W5, Kita-ku, Sapporo
TEL	0117161161
Homepage URL
Email	morim2@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido university hospital
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address	N14 W5, Kita-ku, Sapporo
Tel	0117067636
Email	crjimu@huhp.hokudai.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	北海道大学病院

Other administrative information
Date of disclosure of the study information	2022 Year 02 Month 01 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	43
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	2022 Year 01 Month 17 Day
Date of IRB	2022 Year 02 Month 10 Day
Anticipated trial start date	2022 Year 02 Month 10 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Design;Retrospective observational study Last follow-up data:June 30, 2022 Subjects:The children who underwent pediatric palliative cardiac surgery from August 10, 2017 to December 31, 2020 in Hokkaido university hospital Observational items: cerebral blood flow indices, cerebral oxygenation, background, image examination, blood test, vital signs, etc.

Management information
Registered date	2022 Year 01 Month 30 Day
Last modified on	2022 Year 08 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053293