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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003794
Receipt No. R000004588
Scientific Title Analysis of systemic circulation after subarachnoid hemorrhage:multicenter controlled trial
Date of disclosure of the study information 2010/07/01
Last modified on 2015/06/22

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Basic information
Public title Analysis of systemic circulation after subarachnoid hemorrhage:multicenter controlled trial
Acronym Analysis of systemic circulation after SAH
Scientific Title Analysis of systemic circulation after subarachnoid hemorrhage:multicenter controlled trial
Scientific Title:Acronym Analysis of systemic circulation after SAH
Region
Japan

Condition
Condition subarachnoid hemorrhage
Classification by specialty
Neurosurgery Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Volume management is crucial during intensive care, but an optimal water balance can be difficult to achieve, particularly in patients with subarachnoid hemorrhage (SAH) who often develop cardiopulmonary complications, such as neurogenic pulmonary edema and cardiac failure. We describe herein a trial of minimally invasive PiCCO Plus monitoring of cardiopulmonary function after SAH.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes patients' outcome, incidence of symptomatic vasospasm
Key secondary outcomes incidence of cardiogenic/non-cardiogenic pulmonary edema

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
18 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria subarachnoid hemorrhage patient
Key exclusion criteria no brain stem response
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Isotani
Organization Tokyo Women's Medical University Medical Center East
Division name Department of emergency and critical care medicine
Zip code
Address 2-1-10 Nishi-Ogu, Arakawa-ku, Tokyo
TEL 03-3810-1111
Email isotaner@dnh.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Isotani
Organization Tokyo Women's Medical University Medical Center East
Division name Department of emergency and critical care medicine
Zip code
Address 2-1-10 Nishi-Ogu, Arakawa-ku, Tokyo
TEL 03-3810-1111
Homepage URL http://www.tmd.ac.jp/med/accm/bos/index.html
Email isotaner@dnh.twmu.ac.jp

Sponsor
Institute SAH PiCCO study group
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor SAH PiCCO study group
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 東京医科歯科大学附属病院(東京都)、埼玉医科大学総合医療センター(埼玉県)、山口大学医学部附属病院(山口県)、日本大学医学部附属板橋病院(東京都)、関西医科大学附属枚方病院(大阪府)、日本医科大学附属病院(東京都)、福岡大学医学部附属病院(福岡県)、埼玉医科大学国際医療センター(埼玉県)、長崎大学医学部・歯学部附属病院(長崎県)、日本医科大学多摩永山病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 01 Day

Related information
URL releasing protocol http://www.tmd.ac.jp/med/accm/
Publication of results Partially published

Result
URL related to results and publications http://www.tmd.ac.jp/med/accm/
Number of participants that the trial has enrolled
Results
Output, contractility and afterload were essentially normal after SAH. Intrathoracic blood volume was slightly elevated and this fluid redistribution causes hydrostatic fluid retention in lung tissues on PiCCO monitoring after SAH.
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 Open public recruiting
Date of protocol fixation
2008 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
2012 Year 04 Month 01 Day
Date analysis concluded
2012 Year 10 Month 01 Day

Other
Other related information Preliminary report will be announced at 38th annual meeting of Japanese Association of Acute Medicine and 69th annual meeting of Japanese Association of Neurusurgery

Management information
Registered date
2010 Year 06 Month 21 Day
Last modified on
2015 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004588

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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