UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003794
Receipt number 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 15:35:25

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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 or person

Institute

SAH PiCCO study group

Institute

Department

Personal name



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

Value
https://center6.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