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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023776
Receipt No. R000026660
Scientific Title Clinical study of the improved collection system of the autologous platelet during cardiovascular surgeries.
Date of disclosure of the study information 2016/10/01
Last modified on 2016/08/26

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Basic information
Public title Clinical study of the improved collection system of the autologous platelet during cardiovascular surgeries.
Acronym Improved collection system of the autologous platelet.
Scientific Title Clinical study of the improved collection system of the autologous platelet during cardiovascular surgeries.
Scientific Title:Acronym Improved collection system of the autologous platelet.
Region
Japan

Condition
Condition Cardio-aortic surgeries using extracorporeal circulation.
Classification by specialty
Vascular surgery Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Developing the improved system for the intraoperative colleciton of the autologous platelet during cardio-aortic surgeries using extracorporeal circulation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The platelet counts and the platelet aggregation test during surgeries followed by the postoperative consecutive bleeding amount.
Key secondary outcomes

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
Maneuver
Interventions/Control_1 Collecting the autologous platelet from the extracorporeal circulation circuit. After completing the extracorporeal circulation, the collected autologous platelet will be administrated back to the patients.
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
90 years-old >
Gender Male and Female
Key inclusion criteria The patients who undergo the surgeries during which the extra-corporeal circulation is used.
Key exclusion criteria The patients who refused the participation of this study.
The patients who had been administered the anti-platelet drugus until just before the surgeries.
The patient with severe anemia (Hb<10).
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Tanemoto
Organization Kawasaki Medical School
Division name Department of Cardiovascular Surgery
Zip code
Address 577 Matsushima Kurashiki-city Okayama, 701-0192 JAPAN
TEL 086-462-1111
Email tanemoto@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuo Tanemoto
Organization Kawasaki Medical School
Division name Department of Cardiovascular Surgery
Zip code
Address 577 Matsushima Kurashiki-city Okayama, 701-0192 JAPAN
TEL 086-462-1111
Homepage URL
Email tanemoto@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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
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
2016 Year 10 Month 01 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 Preinitiation
Date of protocol fixation
2016 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 26 Day
Last modified on
2016 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026660

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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