UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053860 |
|---|---|
| Receipt number | R000061155 |
| Scientific Title | Cerebral hemodynamic evaluation during standing stress in patients with acute subarachnoid hemorrhage - Study using transcranial color Doppler method - |
| Date of disclosure of the study information | 2024/04/28 |
| Last modified on | 2024/03/14 13:38:12 |
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Basic information
Public title
Cerebral hemodynamics during head up tilt in patients with acute subarachnoid hemorrhage
Acronym
Cerebral hemodynamics during head up tilt in patients with acute subarachnoid hemorrhage
Scientific Title
Cerebral hemodynamic evaluation during standing stress in patients with acute subarachnoid hemorrhage - Study using transcranial color Doppler method -
Scientific Title:Acronym
Cerebral hemodynamics during head up tilt in patients with acute subarachnoid hemorrhage
Region
| Japan |
Condition
Condition
subarachnoid hemorrhage
Classification by specialty
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There is a concern about cerebral vasospasm in patients with subarachnoid hemorrhage, and there is no general consensus internationally regarding early ambulation. In recent years, research has been conducted on the effectiveness and safety of early ambulation for patients with subarachnoid hemorrhage. A study examining cerebral hemodynamics during gag-up reported that there was no significant difference compared to the supine position. However, no reports have been found that measure cerebral hemodynamics during standing stress in patients with subarachnoid hemorrhage. The purpose of this study was to examine cerebral hemodynamics during head up tilt using transcranial color Doppler technique in patients with acute subarachnoid hemorrhage.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety outcomes will be determined by measuring middle cerebral artery systolic blood velocity, middle cerebral artery mean blood velocity, and middle cerebral artery/internal carotid artery systolic blood velocity ratio on days 3-5 after surgery.
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients were acute subarachnoid hemorrhage patients admitted to Kansai Electric Power Hospital from 2015 to 2024.
Key exclusion criteria
Examples of indications for endovascular treatment and surgical cerebral artery treatment, patients who have completed hemostasis treatment for a ruptured cerebral aneurysm, who do not have severe motor system disease, circulatory system disease, or respiratory disease, and who have pre-symptomatic ADLs. Cerebral blood flow dynamics can be measured using a self-contained ultrasound diagnostic device.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamamoto |
Organization
Kansai Electric Power Hospital
Division name
Rehabilitation department
Zip code
553-0003
Address
2-1-7 Fukushima, Fukushima-ku, Osaka-shi, Osaka Prefecture
TEL
06-6458-5821
hiroshi-yamamoto@krc.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamamoto |
Organization
Kansai Electric Power Hospital
Division name
Rehabilitation department
Zip code
553-0003
Address
2-1-7 Fukushima, Fukushima-ku, Osaka-shi, Osaka Prefecture
TEL
+818031174521
Homepage URL
hiroshi-yamamoto@krc.biglobe.ne.jp
Sponsor or person
Institute
Kansai electric power hospital, department of rehabilitation
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
Kansai electric power hospital
Address
2-1-7 Fukushima, Fukushima-ku, Osaka-shi, Osaka Prefecture
Tel
06-6458-5821
hiroshi-yamamoto@krc.biglobe.ne.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
| 2024 | Year | 04 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
9
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
| 2017 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study was to examine cerebral hemodynamics during head up tilt using transcranial color Doppler technique in patients with acute subarachnoid hemorrhage.As safety outcomes, middle cerebral artery systolic blood velocity, middle cerebral artery mean blood velocity, and middle cerebral artery/internal carotid artery systolic blood velocity ratio were measured 3 to 5 days after surgery.
Management information
Registered date
| 2024 | Year | 03 | Month | 14 | Day |
Last modified on
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061155
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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