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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000019488
Receipt No. R000021363
Scientific Title Registry of Intracerebral hemorrhage treated by endoscopic hematoma evacuation
Date of disclosure of the study information 2015/11/01
Last modified on 2019/04/30

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Basic information
Public title Registry of Intracerebral hemorrhage treated by endoscopic hematoma evacuation
Acronym RICH-trend
Scientific Title Registry of Intracerebral hemorrhage treated by endoscopic hematoma evacuation
Scientific Title:Acronym RICH-trend
Region
Japan

Condition
Condition intracerebral hemorrhage
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Objective is to clarify the safety, the therapeutic efficacy, the rate of surgical complication, and the prognostic factor in endoscopic hematoma evacuation technique for the spontaneous intracerebral hemorrhage.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes i) Descriptive epidemiology study of surgical indication and procedure in endoscopic hematoma evacuation
ii) evaluation of hematoma evacuation ratio and re-bleeding rate
iii) Descriptive epidemiology study of surgical complications in endoscopic hematoma evacuation
iv) Prognostic evaluation of each hematoma type, and evaluation of the ADL level on 1 year after onset


Key secondary outcomes i) Favorable outcome group in endoscope will be compared with the historical control group

ii) Logistic regression analysis with favorable outcome (m-RS 0, 1, and 2) in following dependent variables; anesthesia, surgery time, hematoma evacuation rate, and rehabilitation


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
18 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patient with intracerebral hemorrhage who performed the endoscopic hematoma evacuation surgery between January 2016 and December 2019.
Key exclusion criteria Patients who refused to register
Cases with maximally dilated pupils
Cases with absence of light reflex
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Takuji
Middle name
Last name Yamamoto
Organization Juntendo University Shizuoka Hospital
Division name Neurosurgery
Zip code 410-2295
Address 1129 Nagaoka, Izunokuni City, Shizuoka, Japan
TEL +81-55-948-3111
Email tyamamoto@med-juntendo.jp

Public contact
Name of contact person
1st name Takuji
Middle name
Last name Yamamoto
Organization Juntendo University Shizuoka Hospital
Division name Neurosurgery
Zip code 410-2295
Address 1129 Nagaoka, Izunokuni City, Shizuoka, Japan
TEL -81-948-3111
Homepage URL
Email tyamamoto@med-juntendo.jp

Sponsor
Institute Committee of RICH-trend
Institute
Department

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 Juntendo University Shizuoka Hospital
Address 1129 Nagaoka, Izunokuni-City, Shizuoka, Japan
Tel 055-948-3111
Email tyamamoto@med-juntendo.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
2015 Year 11 Month 01 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
2015 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multicenter prospective cohort observational study

Management information
Registered date
2015 Year 10 Month 25 Day
Last modified on
2019 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021363

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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