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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031125
Receipt No. R000035554
Scientific Title Heparin and coagulation factor levels of the cell saver and cardiopulmonary bypass blood
Date of disclosure of the study information 2018/02/21
Last modified on 2018/02/17

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Basic information
Public title Heparin and coagulation factor levels of the cell saver and cardiopulmonary bypass blood
Acronym Heparin and coagulation factor levels of the cell saver and cardiopulmonary bypass blood
Scientific Title Heparin and coagulation factor levels of the cell saver and cardiopulmonary bypass blood
Scientific Title:Acronym Heparin and coagulation factor levels of the cell saver and cardiopulmonary bypass blood
Region
Japan

Condition
Condition cardiac surgery cases
Classification by specialty
Anesthesiology Cardiovascular surgery Blood transfusion
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 heparin concentration in cell saver blood
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes heparin concentration in cell saver blood
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
90 years-old >
Gender Male and Female
Key inclusion criteria all cases of cardiac surgery with cell saver
Key exclusion criteria none
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Tamura
Organization Nagoya University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code
Address Tsurumai-cho 65, Showa-ku, Nagoya, Aichi, Japan
TEL 052-741-2111
Email takahiro@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Tamura
Organization Nagoya University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code
Address Tsurumai-cho 65, Showa-ku, Nagoya, Aichi, Japan
TEL 052-741-2111
Homepage URL
Email takahiro@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine
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

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 21 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
2018 Year 02 Month 03 Day
Date of IRB
Anticipated trial start date
2018 Year 03 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 This study is to check again about concentration of heparin in cell saver blood. And we will check coagulation test of blood as INR, APTT, Fibrinogen as well.

Management information
Registered date
2018 Year 02 Month 03 Day
Last modified on
2018 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035554

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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