UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035160
Receipt No. R000040074
Official scientific title of the study Study of long-term changes and related factors for size, site, age, gender difference of ruptured cerebral aneurysm, cerebral vasospasm / delayed cerebral ischemia, outcome, and treatment method
Date of disclosure of the study information 2018/12/06
Last modified on 2018/12/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Study of long-term changes and related factors for size, site, age, gender difference of ruptured cerebral aneurysm, cerebral vasospasm / delayed cerebral ischemia, outcome, and treatment method
Title of the study (Brief title) Research on long-term changes and related factors for ruptured cerebral aneurysm
Region
Japan

Condition
Condition subarachnoid hemorrhage, ruptured cerebral aneurysm
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the risk factors of ruptured cerebral aneurysm by the investigation for the change of size, site, age, gender difference, cerebral vasospasm / delayed cerebral ischemia, treatment method, and outcome
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes modified Rankin scale at discharge, 6 month after onset
Key secondary outcomes change of size, site, age, gender difference, cerebral vasospasm / delayed cerebral ischemia, treatment method for ruptured cerebral aneurysm

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
1 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria aneurysmal subarachnoid hemorrhage cases diagnosed by CT, MRI, or cerebrospinal fluid study, and subarachnoid hemorrhage cases caused by ruptured cerebral aneurysm confirmed by CT angiography, MR angiography, or digital subtraction angiography
Key exclusion criteria unknown subarachnoid hemorrhage, subarachnoid hemorrhage without ruptured cerebral aneurysm, subarachnoid hemorrhage without any imaging study
Target sample size 2000

Research contact person
Name of lead principal investigator Fusao Ikawa
Organization Shimane Prefectural Central Hospital
Division name Department of Neurosurgery
Address 4-1-1 Himebara, Izumo City, Shimane,
TEL 0853-22-5111
Email fikawa-nsu@umin.ac.jp

Public contact
Name of contact person Fusao Ikawa
Organization Shimane Prefectural Central Hospital
Division name Department of Neurosurgery
Address 4-1-1 Himebara, Izumo City, Shimane,
TEL 0853-22-5111
Homepage URL
Email fikawa-nsu@umin.ac.jp

Sponsor
Institute Shimane Prefectural Central Hospital
Department of Neurosurgery
4-1-1 Himebara, Izumo City, Shimane,
Institute
Department

Funding Source
Organization Shimane Prefectural Central Hospital
Department of Neurosurgery
4-1-1 Himebara, Izumo City, Shimane,
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 12 Month 06 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 11 Month 01 Day
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information under making paper

Management information
Registered date
2018 Year 12 Month 06 Day
Last modified on
2018 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040074

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.