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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033319
Receipt No. R000037982
Official scientific title of the study 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 2018/07/07

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Basic information
Official scientific title of the study Prospective registry for searching mediators of neurovascular events after aneurysmal subarachnoid hemorrhage
Title of the study (Brief title) 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 Hidenori Suzuki
Organization Mie University
Division name Graduate School of Medicine, Department of Neurosurgery
Address 2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL 059-231-5503
Email suzuki02@clin.medic.mie-u.ac.jp

Public contact
Name of contact person Hidenori Suzuki
Organization Mie University
Division name Graduate School of Medicine, Department of Neurosurgery
Address 2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL 059-231-5503
Homepage URL
Email suzuki02@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University Graduate School of Medicine,
Department of Neurosurgery
Institute
Department

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2013 Year 05 Month 14 Day
Anticipated trial start date
2013 Year 05 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Partially published
URL releasing results
Results
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
2018 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037982

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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