UMIN-CTR Clinical Trial

Basic information
Public title	Effect of middle meningeal artery embolization for preventing recurrence of chronic subdural hematoma
Acronym	Effect of middle meningeal artery embolization for preventing recurrence of chronic subdural hematoma
Scientific Title	Effect of middle meningeal artery embolization for preventing recurrence of chronic subdural hematoma
Scientific Title:Acronym	Effect of middle meningeal artery embolization for preventing recurrence of chronic subdural hematoma
Region	Japan

Condition
Condition	Chronic subdural hematoma
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	evaluation of efficacy of middle meningeal artery embolization for preventing recurrence of chronic subdural hematoma
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1)recurrence within 12 weeks after the treatment 2)subdural space volume a day, 1,4,12 weeks after the treatment 3)neurological deficits
Key secondary outcomes

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	Treatment
Type of intervention	Maneuver
Interventions/Control_1	embolization of middle meningeal artery
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	patient under any of the following conditions 1.Patients who aged 75 or older on the acquisition date 2.rapid recurrence within a month after initial treatment 3.Patients with bilateral lesions 4.patients with antithrombotic medications
Key exclusion criteria	1.Patients with intracranial hypotension 2.Patients with contrast agent allergy 3.Patients who are difficult to treat catheters 4.Patients with advanced jaundice 5.Patients with advanced hypoalbuminemia 6.patients with thrombocytopenia 7.bleeding tendency patient 8.Patients with massive ascites 9.Patients with high grade hepatic encephalopathy 10,High renal function defect 11.pregnant women, patients in lactation 12.Others, patients judged by physicians as inappropriate as subjects of this study
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Ichiro Middle name Last name Nakagawa
Organization	Nara Medical University
Division name	Neurosurgery
Zip code	6390223
Address	Shijo-cho 840, Kashihara, Nara, Japan
TEL	+80-744-22-3051
Email	nakagawa@naramed-u.ac.jp

Public contact
Name of contact person	1st name Ichiro Middle name Last name Nakagawa
Organization	Nara Medical University
Division name	Neurosurgery
Zip code	6390223
Address	Shijo-cho 840, Kashihara, Nara, Japan
TEL	+80-744-22-3051
Homepage URL
Email	nakagawa@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

Funding Source
Organization	Nara Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Nara Medical Univerisity
Address	Shijo-cho 840, Kashihara, Nara, Japan
Tel	9051690857
Email	icthaisin@naramed-u.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	2017 Year 10 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	Enrolling by invitation
Date of protocol fixation	2017 Year 08 Month 01 Day
Date of IRB	2017 Year 11 Month 09 Day
Anticipated trial start date	2017 Year 11 Month 09 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

Management information
Registered date	2017 Year 08 Month 28 Day
Last modified on	2019 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033036

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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