UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of clinical performance of a new blood coagulation test system
Acronym	Clinical performance of a new blood coagulation test system
Scientific Title	Evaluation of clinical performance of a new blood coagulation test system
Scientific Title:Acronym	Clinical performance of a new blood coagulation test system
Region	Japan

Condition
Condition	Cardiac surgery
Classification by specialty	Anesthesiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In cardiac surgery using cardiopulmonary bypass, coagulation management is very important factor to improve patients' perioperative outcome. Numbers of factors including hemodilution, loss of coagulation factors, functional abnormality in platelets, and hypothermia could affect affect coagulation status, and it can be changed dramatically during surgery. In this context, a new blood coagulation test system has been developped. In this study, the study purposes are 1) to compare the new blood coagulation test system with conventional coagulation tests using blood sampled from healthy volunteers and patients undergoing cardiac surgery using cardiopulmonary bypass, and 2) to test reproducibility of the new blood d coagulation test system using blood sampled from healthy volunteers and patients undergoing cardiac surgery using cardiopulmonary bypass.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between the results from the new coagulation test and conventional coagulation tests
Key secondary outcomes	Reproducibility of the results from the new coagulation test

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	Prevention
Type of intervention	Other
Interventions/Control_1	Blood sampling from healthy volunteers (20mL)
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	99 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Healthy volunteers (n=15) (2) Patients undergoing an elective cardiac surgery using cardiopulmonary bypass (n=15)
Key exclusion criteria	Refusal for obtainment of infromed consent
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tokujiro Middle name Last name Uchida
Organization	Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences
Division name	Department of Anesthesiology
Zip code	113-8510
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5325
Email	uchida.mane@tmd.ac.jp

Public contact
Name of contact person	1st name Yudai Middle name Last name Yamamoto
Organization	Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences
Division name	Department of Anesthesiology
Zip code	113-8510
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5325
Homepage URL
Email	ydaimane@tmd.ac.jp

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

Funding Source
Organization	Arkray, Inc
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japanese

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

IRB Contact (For public release)
Organization	Tokyo Medical and Dental University
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel	03-5803-5325
Email	syomu1.adm@tmd.ac.jp

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	2018 Year 04 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	Open public recruiting
Date of protocol fixation	2018 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date	2018 Year 04 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	2018 Year 03 Month 16 Day
Last modified on	2019 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036038