UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028869
Receipt number 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 2024/03/02 14:19:33

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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 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 or person

Institute

Nara Medical University

Institute

Department

Personal name



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

2025 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

2024 Year 03 Month 02 Day



Link to view the page

Value
https://center6.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