UMIN-CTR Clinical Trial

Basic information
Public title	changes in the cerebral blood volume due to the posture change in acute ischemic stroke patients using a near-infrared time-resolved spectroscopy
Acronym	changes in the cerebral blood volume due to the posture change in acute ischemic stroke patients using a near-infrared time-resolved spectroscopy
Scientific Title	changes in the cerebral blood volume due to the posture change in acute ischemic stroke patients using a near-infrared time-resolved spectroscopy
Scientific Title:Acronym	changes in the cerebral blood volume due to the posture change in acute ischemic stroke patients using a near-infrared time-resolved spectroscopy
Region	Japan

Condition
Condition	Patients with first-ever stroke
Classification by specialty	Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to compare of the changes in fore head delta total hemoglobin in response to passive sitting (30 degree) measured within 72 hr and 7-10 days after onset
Basic objectives2	Others
Basic objectives -Others	diagnosis
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of the changes in forehead delta total hemoglobin in response to passive sitting (30 degree) measured within 72 hr and 7-10 days after onset
Key secondary outcomes	1) Comparison of the changes in forehead delta oxy-hemoglobin in response to passive sitting (30 degree) measured within 72 hr and 7-10days after onset 2) Comparison of the changes in forehead delta deoxy-hemoglobin in response to passive sitting (30 degree) measured within 72 hr and 7-10days after onset 3) Comparison of the changes in forehead delta total-hemoglobin index (TOI) in response to passive sitting (30 degree) measured within 72 hr and 7-10 days after onset

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	Device,equipment
Interventions/Control_1	Forehead blood volume measurement obtained TRS-NIRS
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	1. First-ever stroke patient admitted to the hospital within 24 hours from onset 2. patients aged 20 y.o or more 3. Patients who gave written informed consent.
Key exclusion criteria	1. A history of stroke, brain contusion, and brain tumor 2. Unable to hold the 30-degree passive sitting position 3. Receive antihypertensive agents after hospitalization 4. Orthostatic hypotension 5. Skin disease (not suitable for application of the probe to forehead) 6. Patients cannot follow verbal instructions 7. Inappropriate patients due to other reasons
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Watanabe
Organization	Hamamatsu University School of Medicine
Division name	Department of Clinical Pharmacology and Therapetics
Zip code	431-3192
Address	1-20-1, Hanadayama, Higashi-ku, Hamamatsu
TEL	053-435-2385
Email	hwat@hama-med.ac.jp

Public contact
Name of contact person	1st name Naoki Middle name Last name Katayama
Organization	Hamamatsu University School of Medicine
Division name	Department of Clinical Pharmacology and Therapetics
Zip code	4313192
Address	1-20-1, Hanadayama, Higashi-ku, Hamamatsu
TEL	053-435-2385
Homepage URL
Email	katayama_20@yahoo.co.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Hamamatsu University School of Medicine
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	Hamamatsu University School of Medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
Tel	053-435-2850
Email	rinri@hama-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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 27 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	Completed
Date of protocol fixation	2016 Year 06 Month 13 Day
Date of IRB	2016 Year 04 Month 11 Day
Anticipated trial start date	2016 Year 06 Month 28 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 06 Month 27 Day
Last modified on	2020 Year 12 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026395