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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015005
Receipt No. R000017452
Scientific Title precision of prothrombin time examined by Hemochron signature during cardiac surgery
Date of disclosure of the study information 2014/09/01
Last modified on 2017/03/03

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Basic information
Public title precision of prothrombin time examined by Hemochron signature during cardiac surgery
Acronym precision of prothronbin time
Scientific Title precision of prothrombin time examined by Hemochron signature during cardiac surgery
Scientific Title:Acronym precision of prothronbin time
Region
Japan

Condition
Condition Patients undergoing cardiac surgery
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation for precision of prothrombin time using Hemochron signature
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes precision of prothrombin time
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 Patients undergoing cardiac surgery with cardiopulmonary bypass
Key exclusion criteria 1. Patients with he,atological disorder
2. Patints less than 20 years old
Target sample size 64

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Katori
Organization School of Medicine, Keio, University
Division name Anesthesiology
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL 03-3353-1211
Email nbyk@a5.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyuki Katori
Organization School of Medicine, Keio University
Division name Anesthesiology
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL 03-3353-1211
Homepage URL
Email nbyk@a5.keio.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Keio University
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
2014 Year 09 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 Completed
Date of protocol fixation
2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 12 Month 03 Day
Last follow-up date
2015 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information preparation for starting the study

Management information
Registered date
2014 Year 08 Month 31 Day
Last modified on
2017 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017452

Research Plan
Registered date File name
2017/03/03 倫理審査申請書 Ver1.0.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name
2017/03/03 POC PT study data sheet.xlsx


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