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UMIN-CTR Clinical Trial |
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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 | 2019/08/30 |
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 |
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Condition | ||
Condition | Chronic subdural hematoma | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | 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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |