UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055317 |
|---|---|
| Receipt number | R000063204 |
| Scientific Title | Randomized Clinical Trial of Middle Meningeal Artery Embolization for Patients with Refractory Chronic Subdural Hematoma |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2025/01/22 14:13:43 |
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Basic information
Public title
Randomized Clinical Trial of Middle Meningeal Artery Embolization for Patients with Refractory Chronic Subdural Hematoma
Acronym
COMPLEMENT study: ChrOnic subdural hematoMa Patients suppLemented with Embolization of Middle mENingeal artery Trial
Scientific Title
Randomized Clinical Trial of Middle Meningeal Artery Embolization for Patients with Refractory Chronic Subdural Hematoma
Scientific Title:Acronym
COMPLEMENT study: ChrOnic subdural hematoMa Patients suppLemented with Embolization of Middle mENingeal artery Trial
Region
| Japan |
Condition
Condition
Chronic Subdural Hematoma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of middle meningeal artery embolization for refractory chronic subdural hematoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence of chronic subdural hematoma within 6 months after randomization
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Conventional treatment with middle meningeal artery embolization
Interventions/Control_2
Conventional treatment alone
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age >=18
2) pre-mRS 0-3
3) Hematoma thickness >=10mm
4) Having at least one risk factor
Risk factor:
Age >=75, Antithrombotic therapy, DM, Bilateral hematoma, Markwalder grading score >3, Preoperative volume >=130ml, Preoperative midline shift >=8mm, CT appearance (Homogeneous, laminar or separated)
Key exclusion criteria
1) Cr >=1.8
2) Plt <50,000, PT-INR >2
3) Life expectancy <6 months
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Yoshimura |
Organization
Hyogo Medical University
Division name
Department of Neurosurgery
Zip code
663-8501
Address
1-1 Mukogawa, Nishinomiya, Hyogo
TEL
0798-45-6455
s-yoshi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazutaka |
| Middle name | |
| Last name | Uchida |
Organization
Hyogo Medical University
Division name
Department of Neurosurgery
Zip code
663-8501
Address
1-1 Mukogawa, Nishinomiya, Hyogo
TEL
0798-45-6455
Homepage URL
kuchida@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
B.BRAUN AESCULAP
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Boards at Hyogo Medical University
Address
1-1 Mukogawa, Nishinomiya, Hyogo
Tel
0798-45-6455
rinri@hyo-med.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
| 2024 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 08 | 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
| 2024 | Year | 08 | Month | 23 | Day |
Last modified on
| 2025 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063204
