UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032158 |
|---|---|
| Receipt number | R000036664 |
| Scientific Title | Intraoperative Anesthetic Management in Children Undergoing Craniosynostosis Surgery |
| Date of disclosure of the study information | 2018/04/10 |
| Last modified on | 2018/04/09 09:45:24 |
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Basic information
Public title
Intraoperative Anesthetic Management in Children Undergoing Craniosynostosis Surgery
Acronym
Intraoperative Anesthetic Management in Children Undergoing Craniosynostosis Surgery
Scientific Title
Intraoperative Anesthetic Management in Children Undergoing Craniosynostosis Surgery
Scientific Title:Acronym
Intraoperative Anesthetic Management in Children Undergoing Craniosynostosis Surgery
Region
| Japan |
Condition
Condition
Craniosynostosis
Classification by specialty
| Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate perioperative blood loss, transfusion volume, and related adverse events of a standardized anesthetic protocol for craniofacial reconstruction for children
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Perioperative blood loss
Key secondary outcomes
Perioperative transfusion volume
Perioperative complications
Length of ICU stay
Length of hospital stay
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
| Not applicable |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All children undergoing craniofacial reconstruction
Key exclusion criteria
None
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuro Kagawa |
Organization
Hyogo Prefectural Kobe Children's Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-6-7, Minatojimaminamicho, Chuo-Ku, Kobe, Hyogo 650-0004 Japan
TEL
078-945-7300(+81-78-945-7300)
kagawa_kch@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aya Sueda |
Organization
Hyogo Prefectural Kobe Children's Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-6-7, Minatojimaminamicho, Chuo-Ku, Kobe, Hyogo 650-0004 Japan
TEL
078-945-7300(+81-78-945-7300)
Homepage URL
http://www.hyogo-kodomo-hosp.com/trials/ethics_committee/index.php
sueda_kch@hp.pref.hyogo.jp
Sponsor or person
Institute
Hyogo Prefectural Kobe Children's Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2018 | Year | 04 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Perioperative blood loss
Perioperative transfusion
Perioperative complications
Length of ICU stay
Length of hospital stay
Management information
Registered date
| 2018 | Year | 04 | Month | 09 | Day |
Last modified on
| 2018 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036664
