UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011653
Receipt number R000013627
Scientific Title Usefulness of Stroke Volume Variation to assess blood volume during blood removal for autologous blood transfusion in pediatric patients
Date of disclosure of the study information 2013/09/04
Last modified on 2015/05/18 17:12:57

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Basic information

Public title

Usefulness of Stroke Volume Variation to assess blood volume during blood removal for autologous blood transfusion in pediatric patients

Acronym

Usefulness of Stroke Volume Variation in pediatric patients

Scientific Title

Usefulness of Stroke Volume Variation to assess blood volume during blood removal for autologous blood transfusion in pediatric patients

Scientific Title:Acronym

Usefulness of Stroke Volume Variation in pediatric patients

Region

Japan


Condition

Condition

trigonocephaly

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Verifying Stroke Volume Variation whether to reflect changes in the blood volume in pediatric patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Stroke Volume Variation, Heart rate, mean Blood pressure, and Peripheral venous pressure during blood removal and fluid loading of 10 ml/kg

Key secondary outcomes



Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

the blood removal(10 ml/kg) for autologous blood transfusion

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

1 years-old <=

Age-upper limit

10 years-old >=

Gender

Male and Female

Key inclusion criteria

period: July 2013 from September 2012
American Society of Anesthesiologists(ASA) physical status 1 or 2 patients, who were undergoing general anesthesia for cranioplasty.

Key exclusion criteria

Past history of arrythmia or congenital heart disease
Anemia: hemoglobin less than 10 g/dL
Inadequate operative record
Hypotension: we stopped the blood removal because mean blood pressure decreased 20% lower than before blood removal

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takahiro Tadokoro

Organization

University of the Ryukyus

Division name

Department of Anesthesiology

Zip code


Address

207 Uehara, Nishihara-cho, Okinawa, 903-0215, Japan

TEL

08034237522

Email

rover2727@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takahiro Tadokoro

Organization

University of the Ryukyus

Division name

Department of Anesthesiology

Zip code


Address

207 Uehara, Nishihara-cho, Okinawa, 903-0215, Japan

TEL

08034237522

Homepage URL


Email

rover2727@yahoo.co.jp


Sponsor or person

Institute

University of the Ryukyus

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

2013 Year 09 Month 04 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

Completed

Date of protocol fixation

2012 Year 07 Month 19 Day

Date of IRB


Anticipated trial start date

2012 Year 07 Month 19 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

observational study


Management information

Registered date

2013 Year 09 Month 04 Day

Last modified on

2015 Year 05 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013627


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name