UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046780 |
|---|---|
| Receipt number | R000053293 |
| Scientific Title | Changes in cerebral blood flow indices by transcranial doppler and cerebral oxygenation by near infrared spectroscopy in pediatric palliative cardiac surgery |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2022/08/02 09:07:16 |
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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
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
morim2@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido university hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053293
