UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019488 |
|---|---|
| Receipt number | 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 08:29:41 |
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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
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
tyamamoto@med-juntendo.jp
Sponsor or person
Institute
Committee of RICH-trend
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
Juntendo University Shizuoka Hospital
Address
1129 Nagaoka, Izunokuni-City, Shizuoka, Japan
Tel
055-948-3111
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021363
