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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023226
Receipt No. R000026719
Scientific Title Clinical evaluation of dielectric blood coagulometry as a method to quantify the effect of anti-platelet drugs
Date of disclosure of the study information 2016/10/01
Last modified on 2018/09/04

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Basic information
Public title Clinical evaluation of dielectric blood coagulometry as a method to quantify the effect of anti-platelet drugs
Acronym Dielectric blood coagulometry as a method to quantify the effect of anti-platelet drugs
Scientific Title Clinical evaluation of dielectric blood coagulometry as a method to quantify the effect of anti-platelet drugs
Scientific Title:Acronym 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
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 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

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

Other administrative information
Date of disclosure of the study information
2016 Year 10 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 Preinitiation
Date of protocol fixation
2016 Year 10 Month 01 Day
Date of IRB
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

Other
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

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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