UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pathological diagnosis and clinical characteristics of cerebral amyloid angiopathy-related intracerebral hemorrhage
Title of the study (Brief title)	Pathological diagnosis and clinical characteristics of CAA-ICH
Region	Japan

Condition
Condition	Cerebral amyloid angiopathy
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Cerebral amyloid angiopathy-related intracerebral hemorrhage (CAA-ICH) typically presents recurrent or multiple lobar hemorrhage. Pathological survey and proof of amyloid-laden blood vessels are needed to make definite diagnosis of CAA. We investigate the efficacy of biopsy and pathological diagnosis of CAA –ICH in patients with subcortical hemorrhage who undergo hematoma evacuation with craniotomy and review the clinical and radiological characteristics of pathologically proven CAA patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We will clarify clinical characteristics and efficacy of pathological diagnosis of CAA-ICH. We will establish the method of clinical diagnosis and treatment of CAA.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients with subcortical hemorrhage who undergo hematoma evacuation surgery and biopsy of hematoma and cerebral parenchyma for pathological diagnosis. Written informed consent about the objects, methods, expected results and hazard of this study must be obtained from the patients. In patients who had underwent craniotomy and biopsy for pathological survey before an application of this study, surgical consent form and informed consent about biopsy for pathological survey documented in medical records can be regarded as a written informed consent for this study.
Key exclusion criteria	Cases with subcortical hemorrhages which are derived from causes other than CAA.
Target sample size	10

Research contact person
Name of lead principal investigator	Takao Hashimoto
Organization	Aizawa Hospital
Division name	Department of Neurology
Address	2-5-1 Honjo, Matsumoto 390-8510, Japan
TEL	0263-33-8600
Email	sinke-dr@ai-hosp.or.jp

Public contact
Name of contact person	Tadashi Doden
Organization	Aizawa Hospital
Division name	Department of Neurology
Address	2-5-1 Honjo, Matsumoto 390-8510, Japan
TEL	0263-33-8600
Homepage URL
Email	aidr214@ai-hosp.or.jp

Sponsor
Institute	Aizawa Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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	相澤病院（長野県）

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 01 Day
Anticipated trial start date	2014 Year 06 Month 10 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	Published
URL releasing results
Results
Other related information	We investigate the efficacy of biopsy and pathological diagnosis of CAA related ICH in patients with subcortical hemorrhage who undergo hematoma evacuation with craniotomy and review the clinical and radiological characteristics of pathologically proven CAA patients.

Management information
Registered date	2014 Year 07 Month 12 Day
Last modified on	2016 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016915