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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031769
Receipt No. R000036038
Scientific Title Evaluation of clinical performance of a new blood coagulation test system
Date of disclosure of the study information 2018/04/01
Last modified on 2019/09/18

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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/ctr_e/ctr_view.cgi?recptno=R000036038

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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