UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024970 |
|---|---|
| Receipt number | R000028379 |
| Scientific Title | Diagnosis of vasospasm after SAH with rCBF by NIRS |
| Date of disclosure of the study information | 2016/12/15 |
| Last modified on | 2024/05/31 12:42:31 |
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Basic information
Public title
Diagnosis of vasospasm after SAH with rCBF by NIRS
Acronym
Diagnosis of vasospasm after SAH with rCBF by NIRS
Scientific Title
Diagnosis of vasospasm after SAH with rCBF by NIRS
Scientific Title:Acronym
Diagnosis of vasospasm after SAH with rCBF by NIRS
Region
| Japan |
Condition
Condition
SAH
Classification by specialty
| Anesthesiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of vasospasm with rCBF measured by NIRS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ditection of vasospasm by rCBF
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Measurement of rCBF by injection of ICG
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnoased SAH
Key exclusion criteria
Wound of forehead
allergy of iodine
can not take consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Kato |
Organization
NCVC
Division name
Anesthesiology
Zip code
Address
Fujishirodai 5-7-1, Suita, Osaka
TEL
06-6833-5012
numberboy1122@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Yoshitani |
Organization
National cerebral and cardiovascular center
Division name
Anesthesiology
Zip code
Address
Fujishirodai 5-7-1, Suita, Osaka
TEL
06-6833-5012
Homepage URL
numberboy1122@yahoo.co.jp
Sponsor or person
Institute
NCVC
Institute
Department
Personal name
Funding Source
Organization
Japan society for promotion of sicientce
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
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
| 2016 | Year | 12 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
11/28 8 cases entered.Research is ongoing.
2018 12/26 20 cases have been entered.
Suspended due to transfer of research staff.
Management information
Registered date
| 2016 | Year | 11 | Month | 24 | Day |
Last modified on
| 2024 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028379
