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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020920
Receipt No. R000024121
Scientific Title Clinical evaluation of dielectric blood coagulometry: observational study
Date of disclosure of the study information 2016/02/08
Last modified on 2018/09/04

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Basic information
Public title Clinical evaluation of dielectric blood coagulometry: observational study
Acronym Clinical evaluation of dielectric blood coagulometry
Scientific Title Clinical evaluation of dielectric blood coagulometry: observational study
Scientific Title:Acronym Clinical evaluation of dielectric blood coagulometry
Region
Japan

Condition
Condition Patients undergoing cardiovascular surgery using cardiopulmonary bypass
Classification by specialty
Anesthesiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare clinical performances of dielectric coagulometer with thromboelastograph and laboratory based blood coagulation tests.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between dielectric blood coagulometry and thromboelastography/laboratory based blood coagulation tests.
Key secondary outcomes Correlation between dielectric blood coagulometry and factors related with thrombosis.

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 Cardiovascular surgery using cardiopulmonary bypass
Key exclusion criteria 1.Patients reated with hemodialysis before surgery
2.Patients with previous history of cardiovascular surgery.
3.Patients who refuse obtainment of informed consent.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tokujiro Uchida
Organization Tokyo Medical and Dental University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5325
Email pocanalysis-group@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yudai Yamamoto
Organization Tokyo Medical and Dental University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5325
Homepage URL
Email pocanalysis-group@umin.ac.jp

Sponsor
Institute Department of Anesthesiology, Tokyo Medical and Dental University, Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Sony Corporation
Name of secondary funder(s) Sony Corporation

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 東京医科歯科大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 08 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 No longer recruiting
Date of protocol fixation
2015 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In this study, blood samples are collected from 100 patients undergoing cardiovascular surgery using cardiopulmonary bypass.

Results from dielectric blood coagulometry are compared with those from thromboelastography(CK, CRT, CKH, CFF)and rotational thromboelastometry (EXTEM, INTEM, FIBTEM, HEPTEM, and APTEM), laboratory based blood coagulation tests(PT, APTT, Fibrinogen, FDP, AT-III), and inflammatory biomarkers, which can be related with coagulation abnormality.
Samples are collected following points.
(1) after induction of anesthesia
(2) end of cardiopulmonary bypass (after protamine administration)
(3) one hour after the end of cardiopulmonary bypass
(4) two hours after the end of cardiopulmonary bypass
(5) end of surgery

Management information
Registered date
2016 Year 02 Month 07 Day
Last modified on
2018 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024121

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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