UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical evaluation of dielectric blood coagulometry: observational study
Title of the study (Brief title)	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	Tokujiro Uchida
Organization	Tokyo Medical and Dental University Graduate School of Medicine
Division name	Department of Anesthesiology
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	Yudai Yamamoto
Organization	Tokyo Medical and Dental University Graduate School of Medicine
Division name	Department of Anesthesiology
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

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 12 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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