UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022279
Receipt number R000025672
Scientific Title The effect of hemodilution with various isotonic solution
Date of disclosure of the study information 2016/05/11
Last modified on 2016/11/15 16:06:44

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Basic information

Public title

The effect of hemodilution with various isotonic solution

Acronym

The effect of hemodilution with various isotonic solution

Scientific Title

The effect of hemodilution with various isotonic solution

Scientific Title:Acronym

The effect of hemodilution with various isotonic solution

Region

Japan


Condition

Condition

none

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the hemodilution with various isotonic solution

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Activatd clotting time,clot rate,platelet function are investigated using Sonoclot

Key secondary outcomes

coagulation parameters
PT,APTT,Ht,platelet,Factor8,von Willebrand Factor,fibrinogen,AT3


Base

Study type

Interventional


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

blood sampling

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


Not applicable

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

healthy volunteers

Key exclusion criteria

coagulation defects

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiaki Minami

Organization

Osaka Medical College

Division name

Department of Anesthesiology

Zip code


Address

2-7 Daigaku-machi, Takatsuki

TEL

072-683-1221

Email

ane022@osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenta Nakao

Organization

Osaka Medical College

Division name

Department of Anesthesiology

Zip code


Address

2-7 Daigaku-machi, Takatsuki

TEL

072-683-1221

Homepage URL


Email

ane086@osaka-med.ac.jp


Sponsor or person

Institute

Department of Anesthesiology,Osaka Medical College

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology,Osaka Medical College

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

大阪医科大学附属病院


Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 11 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

2015 Year 05 Month 10 Day

Date of IRB


Anticipated trial start date

2015 Year 05 Month 11 Day

Last follow-up date

2016 Year 10 Month 31 Day

Date of closure to data entry

2016 Year 10 Month 31 Day

Date trial data considered complete

2016 Year 10 Month 31 Day

Date analysis concluded

2017 Year 04 Month 01 Day


Other

Other related information



Management information

Registered date

2016 Year 05 Month 11 Day

Last modified on

2016 Year 11 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025672


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name