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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000047814 |
Receipt No. | R000054512 |
Scientific Title | Relationship between cerebral circulation indices and prognosis in pediatric cardiac surgery with cardiopulmonary bypass |
Date of disclosure of the study information | 2022/06/20 |
Last modified on | 2022/05/20 |
Basic information | ||
Public title | Relationship between cerebral circulation indices and prognosis in pediatric cardiac surgery with cardiopulmonary bypass | |
Acronym | Cerebral circulation and prognosis in pediatric cardiac surgery | |
Scientific Title | Relationship between cerebral circulation indices and prognosis in pediatric cardiac surgery with cardiopulmonary bypass | |
Scientific Title:Acronym | Cerebral circulation and prognosis in pediatric cardiac surgery | |
Region |
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Condition | ||||
Condition | congenital heart disease | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate relationship between the cerebral circulation indices and the prognosis in pediatric cardiac surgery with cardiopulmonary bypass |
Basic objectives2 | Others |
Basic objectives -Others | serach of the prognosis |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Relationship between cerebral blood flow indices by transcranial doppler and prognosis in pediatric cardiac surgery with cardiopulmonary bypass |
Key secondary outcomes | Relationship between cerebral oxygenation by near infrared spectroscopy and prgnosis in pediatric cardiac surgery with cardiopulmonary bypass
Relationship between other physiological parameters and prognosis |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | The patients that underwent pediatric cardiac surgery with cardiopulmonary bypass 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 |
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Target sample size | 150 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Other | |
Other related information | Design;Retrospective observational study
Last follow-up data:March 31, 2023 Subjects:The children who underwent pediatric cardiac surgery with cardiopulmonary bypass 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, early outcome, neurological outcome, etc. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054512 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |