UMIN-CTR Clinical Trial

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
Institute	TOKYO WOMEN'S MEDICAL UNIVERSITY
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020196