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
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
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
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
