UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical evaluation of dielectric blood coagulometry as a method to quantify the effect of anti-platelet drugs
Title of the study (Brief title)	Dielectric blood coagulometry as a method to quantify the effect of anti-platelet drugs
Region	Japan

Condition
Condition	Thromboembolism
Classification by specialty	Vascular surgery Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study clinical usefulness of dielectric blood coagulometry as a method to evaluate the effect of anti-platelet drugs
Basic objectives2	Others
Basic objectives -Others	Clinical evaluation of a new method to quantify the platelet function
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison between dielectronic blood coagulometry and two platelet function testings [TEG6s(Hemonetics) and Multiplate (Roche)]
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 an elective vascular surgery, who have been prescirbed with anti-platelet drug(s) for more than 1 month, and healthy volunteers.
Key exclusion criteria	Men or women who deny obtainment of informed consent.
Target sample size	60

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	Tokyo Medical and Dental University, Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 10 Month 01 Day
Anticipated trial start date	2016 Year 10 Month 01 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 patients undergoing vascular surgery (1) before perioperative interruption of anti-platelet-drugs, (2) after the induction of anesthesia, and (3) immediately after the end of surgery. Platelet function is analyzed using dielectric blood coagulometry (SONY), Multiplate platelet function analyzer (Roche Diagnostics), and Thromboelastograph (TEG6s, Platelet mapping, Haemonetics). Data obtained from these three methodologies are compared, and we analyze the relationship between the results from these platelet function tests and postoperative bleeding.

Management information
Registered date	2016 Year 07 Month 19 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=R000026719