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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028869
Receipt No. R000033036
Scientific Title Effect of middle meningeal artery embolization for preventing recurrence of chronic subdural hematoma
Date of disclosure of the study information 2017/10/01
Last modified on 2018/09/06

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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
Middle name
Last name Ichiro Nakagawa
Organization Nara Medical University
Division name Neurosurgery
Zip code
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
Middle name
Last name Ichiro Nakagawa
Organization Nara Medical University
Division name Neurosurgery
Zip code
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
Address
Tel
Email

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
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
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
2018 Year 09 Month 06 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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