UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031246
Receipt number R000035676
Scientific Title Prevention of cerebral vasospasm following aneurysmal subarachnoid hemorrhage using cilostazol administration with combination enteral and parental nutrition therapy - randomized open-labeled multi-institutional prospective study
Date of disclosure of the study information 2018/02/10
Last modified on 2023/02/16 12:54:32

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Basic information

Public title

Prevention of cerebral vasospasm following aneurysmal subarachnoid hemorrhage using cilostazol administration with combination enteral and parental nutrition therapy - randomized open-labeled multi-institutional prospective study

Acronym

Prevention of cerebral vasospasm following aneurysmal subarachnoid hemorrhage using cilostazol administration with combination enteral and parental nutrition therapy

Scientific Title

Prevention of cerebral vasospasm following aneurysmal subarachnoid hemorrhage using cilostazol administration with combination enteral and parental nutrition therapy - randomized open-labeled multi-institutional prospective study

Scientific Title:Acronym

Prevention of cerebral vasospasm following aneurysmal subarachnoid hemorrhage using cilostazol administration with combination enteral and parental nutrition therapy

Region

Japan


Condition

Condition

Aneurysmal subarachnoid hemorrhage

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the efficacy of cilostazol administration with combination enteral and parental nutrition therapy for prevention of cerebral vasospasm following aneurysmal subarachnoid hemorrhage

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

modified Rankin scale 0-2 at discharge

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

cilostazol administration

Interventions/Control_2

combination enteral and parental nutrition therapy

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1. WFNS grade: I-IV
2. No new hemorrhage or infarction on computed tomography images one day after surgical intervention
3. No allergy or adverse effect for cilostazol
4. Written informed consent for attending this study

Key exclusion criteria

1.WFNS grade: V
2. New hemorrhage or infarction on computed tomography images one day after surgical intervention
3. Allergy or adverse effect for cilostazol
4. No contraindication of cilostazol according to package medical insert

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eiji Kohmura

Organization

Kobe University Hospital

Division name

Neurosurgery

Zip code


Address

7-5-1,Kusunoki-cho,Chu-ku,Kobe,Hyogo

TEL

078-382-5966

Email

ekohmura@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hidehito Kimura

Organization

Kobe University Hospital

Division name

Neurosurgery

Zip code


Address

7-5-1,Kusunoki-cho,Chu-ku,Kobe,Hyogo

TEL

078-382-5966

Homepage URL


Email

hkimura@med.kobe-u.ac.jp


Sponsor or person

Institute

Department of Neurosurgery, Kobe University Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Neurosurgery, Kobe University Hospital

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


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



Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 10 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

Preinitiation

Date of protocol fixation

2018 Year 02 Month 10 Day

Date of IRB


Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date

2027 Year 12 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

2018 Year 02 Month 10 Day

Last modified on

2023 Year 02 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035676


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name