UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017412
Receipt number R000020196
Scientific Title Relationship between cardiopulmonary bypass time, platelet count and bleeding amount during cardiovascular surgery
Date of disclosure of the study information 2015/05/05
Last modified on 2020/09/11 08:06:47

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Basic information

Public title

Relationship between cardiopulmonary bypass time, platelet count and bleeding amount during cardiovascular surgery

Acronym

A new strategy of transfusion for cardiovascular operation

Scientific Title

Relationship between cardiopulmonary bypass time, platelet count and bleeding amount during cardiovascular surgery

Scientific Title:Acronym

The longer CPB time, the more bleeding amount during cardiac surgery

Region

Japan


Condition

Condition

Cardiovascular operation using cardioplumonary bypass

Classification by specialty

Anesthesiology Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We compare total amount of blood transfusion and bleeding divided by CPB time.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Total amount of blood transfusion and bleeding

Key secondary outcomes



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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Elective cardiovascular operation using cardioplumonary bypass

Key exclusion criteria

The patients we cannot get the informed consent.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Mitsuharu
Middle name
Last name Kodaka

Organization

Tokyo women's medical university medical center east

Division name

Anesthesiology

Zip code

116-8567

Address

2-1-10 Nishi-ogu Arakawaku Tokyo

TEL

03-3810-1111

Email

kmkodaka@cb3.so-net.ne.jp


Public contact

Name of contact person

1st name MITSHARU
Middle name
Last name KODAKA

Organization

TOKYO WOMEN'S MEDICAL UNIVERSITY

Division name

ANESTHESIOLOGY

Zip code

116-8567

Address

2-1-10 NISHI-OGU ARAKAWAKU TOKYO

TEL

09022047740

Homepage URL


Email

kmkodaka@cb3.so-net.ne.jp


Sponsor or person

Institute

TOKYO WOMEN'S MEDICAL UNIVERSITY

Institute

Department

Personal name



Funding Source

Organization

KAKEN fund from public health and labor ministry

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

TOKYO WOMEN'S MEDICAL UNIVERSITY

Address

2-1-10 NISHI-OGU ARAKAWAKU TOKYO

Tel

+819022047740

Email

manachan048777@yahoo.co.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

150208

Org. issuing International ID_1

TOKYO WOMEN'S MEDICAL UNIVERSITY

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2015 Year 05 Month 05 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

160

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 05 Day

Date of IRB

2015 Year 10 Month 09 Day

Anticipated trial start date

2015 Year 07 Month 01 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observatory study


Management information

Registered date

2015 Year 05 Month 04 Day

Last modified on

2020 Year 09 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020196


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name