UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057789 |
|---|---|
| Receipt number | R000066048 |
| Scientific Title | Neuroendovascular treatment for chronic subdural hematoma trial |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/03 16:27:04 |
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Basic information
Public title
Catheterisation for chronic subdural hematoma
Acronym
CSHCatherter
Scientific Title
Neuroendovascular treatment for chronic subdural hematoma trial
Scientific Title:Acronym
CSHNET
Region
| Japan |
Condition
Condition
chronic subdural hematoma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy of endovascular treatment for chronic subdural haematomas and the optimal timing of its implementation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Recurrence rate (patients with a relapse within one month are defined to have relapsed); mesure mRS at three months and one year.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
neuroendovascular therapy
Interventions/Control_2
conventional therapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients must be at least 20 years old with a diagnosis of chronic subdural haematoma on CT. Medical treatment or follow-up is the treatment of choice if symptoms (neurological local symptoms such as gait disturbance, cognitive impairment, impaired consciousness, paralysis and headache) are minor, while surgical treatment is the treatment of choice for all but the most minimally symptomatic cases
Key exclusion criteria
Persons who have undergone craniotomy within 6 months.
Persons with a history of shunt surgery.
Persons suspected of having low medullary pressure syndrome.
Other persons deemed unsuitable by the researcher.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Inoue |
Organization
South Miyagi Medical Center
Division name
Department of Neurosurgery
Zip code
9891253
Address
38-1 Nishi, Ogawara Miyagi Japan
TEL
0224-51-5500
t.inoue@southmiyagi-mc.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Inoue |
Organization
South Miyagi Medical Center
Division name
Department of Neurosurgery
Zip code
9891253
Address
38-1 Nishi Ogawara Miyagi Japan
TEL
0224-51-5500
Homepage URL
t.inoue@southmiyagi-mc.jp
Sponsor or person
Institute
South Miyagi Medical Center
Institute
Department
Personal name
Takashi Inoue
Funding Source
Organization
South Miyagi Medical Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
South Miyagi Medical Center
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
South Miyagi Medical Center
Address
38-1 Nishi Ogawara Miyagi Japan
Tel
0222931111
t.inoue@southmiyagi-mc.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
宮城県
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | 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
| 2025 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | 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
| 2025 | Year | 05 | Month | 07 | Day |
Last modified on
| 2025 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066048
