UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011843
Receipt number R000013734
Scientific Title Effects of cilostazol on cerebral vasospasm after subarachnoid hemorrhage
Date of disclosure of the study information 2013/12/01
Last modified on 2013/09/24 08:51:40

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Basic information

Public title

Effects of cilostazol on cerebral vasospasm after subarachnoid hemorrhage

Acronym

Effects of cilostazol on cerebral vasospasm

Scientific Title

Effects of cilostazol on cerebral vasospasm after subarachnoid hemorrhage

Scientific Title:Acronym

Effects of cilostazol on cerebral vasospasm

Region

Japan


Condition

Condition

subarachnoid hemorrhage

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Objective is to evaluate effect of cilostazol on cerebra vasospasm after subarachnoid hemorrhage, change of neurological symptom, side effect, and long-term prognosis by double-blind test.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

change of cerebra vasospasm before and after treatment

Key secondary outcomes

functional prognosis (m-RS, GOS), evaluation of cerebral infarction with CT or MRI, frequency of adverse event


Base

Study type


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

cilostazol

Interventions/Control_2

placebo

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

patient over 20 years-old
patient consented with informed consent from patient's or another person

Key exclusion criteria

patient did not consent to informed consent
patient with drug allergy
pregnant patient or patient of expectant pregnancy

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hidetoshi Kasuya

Organization

Tokyo Women's Medical University Medical Center East

Division name

Department of Neurosurgery

Zip code


Address

Nishiogu 2-1-10 Arakawa-ku, Tokyo

TEL

03-3810-1111

Email

kasuyane@dnh.twmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shiegru Tani

Organization

Tokyo Women's Medical University Medical Center East

Division name

Department of Neurosurgery

Zip code


Address

Nishiogu 2-1-10 Arakawa-ku, Tokyo

TEL

03-3810-1111

Homepage URL

http://dnh.twmu.ac.jp

Email

stanine@dnh.twmu.ac.jp


Sponsor or person

Institute

Tokyo Women's Medical University Medical Center East Department of Neurosurgery

Institute

Department

Personal name



Funding Source

Organization

Tokyo Women's Medical University Medical Center East Department of Neurosurgery

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

東京女子医科大学東医療センター脳神経外科 (東京都)


Other administrative information

Date of disclosure of the study information

2013 Year 12 Month 01 Day


Related information

URL releasing protocol

http://dnh.twmu.ac.jp

Publication of results

Unpublished


Result

URL related to results and publications

http://dnh.twmu.ac.jp

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

Preinitiation

Date of protocol fixation

2013 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 12 Month 01 Day

Last follow-up date

2019 Year 06 Month 30 Day

Date of closure to data entry

2019 Year 12 Month 01 Day

Date trial data considered complete

2019 Year 12 Month 31 Day

Date analysis concluded

2020 Year 01 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 09 Month 24 Day

Last modified on

2013 Year 09 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013734


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name