UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033319 |
|---|---|
| Receipt number | R000037982 |
| Scientific Title | Prospective registry for searching mediators of neurovascular events after aneurysmal subarachnoid hemorrhage |
| Date of disclosure of the study information | 2018/07/07 |
| Last modified on | 2020/01/07 10:40:33 |
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Basic information
Public title
Prospective registry for searching mediators of neurovascular events after aneurysmal subarachnoid hemorrhage
Acronym
pSEED
Scientific Title
Prospective registry for searching mediators of neurovascular events after aneurysmal subarachnoid hemorrhage
Scientific Title:Acronym
pSEED
Region
| Japan |
Condition
Condition
aneurysmal subarachnoid hemorrhage
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate if blood levels of matricellular proteins are useful for early diagnosis or prediction of neurovascular events such as early brain injury, cerebral vasospasm, delayed cerebral ischemia, and hydrocephalus after subarachnoid hemorrhage
Basic objectives2
Others
Basic objectives -Others
To investigate if blood levels of matricellular proteins predict outcomes after subarachnoid hemorrhage.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
3-month outcome
Delayed cerebral infarction
Key secondary outcomes
Matricellular protein levels in blood at days 1-3, 4-6, 7-9, and 10-12
Early brain injury
Cerebral vasospasm
Delayed cerebral ischemia
Chronic hydrocephalus
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Written informed consent
2. More than 20 years of age at onset
3. modified Rankin Scale 0-2 before onset
4. Subarachnoid hemorrhage (SAH) on computed tomography (CT) scans or lumbar puncture
5. Saccular aneurysm as the cause of SAH confirmed on digital subtraction angiography or CT angiography
6. Aneurysmal obliteration by clipping or coiling within 48 hours of onset
Key exclusion criteria
1. Non-idiopathic saccular aneurysms including traumatic, dissecting, tumor-related, and inflammatory aneurysms
2. Aneurysm treatment by parent artery occlusion
3. Patients with procedure-related complications
4. Severe systemic complications limiting routine post-operative managements
5. Diseases that potentially affect matricellular protein levels
6. Patients who are judged as being inappropriate by attending neurosurgeons
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Suzuki |
Organization
Mie University
Division name
Graduate School of Medicine, Department of Neurosurgery
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-231-5503
suzuki02@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Suzuki |
Organization
Mie University
Division name
Graduate School of Medicine, Department of Neurosurgery
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-231-5503
Homepage URL
suzuki02@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Graduate School of Medicine,
Department of Neurosurgery
Institute
Department
Personal name
Funding Source
Organization
Mie University Graduate School of Medicine,
Department of Neurosurgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of Mie University Hospital
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
Tel
059-231-5246
s-kenkyu@mo.medic.mie-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
| 2018 | Year | 07 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
305
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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study to investigate the relationships between blood levels of various matricellular proteins at days 1-3, 4-6, 7-9, and/or 10-12, and neurovascular events and/or 3-month outcome after aneurysmal subarachnoid hemorrhage.
Management information
Registered date
| 2018 | Year | 07 | Month | 07 | Day |
Last modified on
| 2020 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037982
