UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023971 |
|---|---|
| Receipt number | R000024966 |
| Scientific Title | Disturbance of autonomic nervous function in the severe cases of intracranial hypotension |
| Date of disclosure of the study information | 2016/09/08 |
| Last modified on | 2021/03/12 14:29:44 |
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Basic information
Public title
Disturbance of autonomic nervous function in the severe cases of intracranial hypotension
Acronym
Disturbance of autonomic nervous function in the severe cases of intracranial hypotension
Scientific Title
Disturbance of autonomic nervous function in the severe cases of intracranial hypotension
Scientific Title:Acronym
Disturbance of autonomic nervous function in the severe cases of intracranial hypotension
Region
| Japan |
Condition
Condition
intracranial hypotension
Classification by specialty
| Medicine in general | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the autonomic nervous function in the severe cases of intracranial hypotension
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
autonomic nervous function
anti-acetylcholine receptor antibody
transferrin
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
intraclanial hypotension
Key exclusion criteria
traffic accident
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Araki |
Organization
Saitama Medical University Faculty of medicine
Division name
Department of Neurology
Zip code
350-0495
Address
38 Morohongou Moroyama Saitama
TEL
049-276-1209
csfh@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Makiko |
| Middle name | |
| Last name | Hirayama |
Organization
Saitama Medical University Faculty of Medicine
Division name
Department of Neurology
Zip code
350-0495
Address
38 Morohongou Moroyama Saitama
TEL
049-276-1209
Homepage URL
csfh@saitama-med.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Saitama Medical University Hospital Institutional Review Board
Address
38 Morohongo Moroyama-machi Iruma-gun Saitama
Tel
049-276-1354
hirb@saitama-med.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
埼玉医科大学病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 08 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
33
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Antibody test analysis was delayed due to the earthquake of Kumamoto.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
We will observe the patients who suffer from lumber puncture examinations
Management information
Registered date
| 2016 | Year | 09 | Month | 07 | Day |
Last modified on
| 2021 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024966
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/03/11 | 16-049計画書清書版.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
