Unique ID issued by UMIN | UMIN000031769 |
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Receipt number | 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 10:55:04 |
Evaluation of clinical performance of a new blood coagulation test system
Clinical performance of a new blood coagulation test system
Evaluation of clinical performance of a new blood coagulation test system
Clinical performance of a new blood coagulation test system
Japan |
Cardiac surgery
Anesthesiology | Cardiovascular surgery |
Others
NO
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.
Efficacy
Correlation between the results from the new coagulation test and conventional coagulation tests
Reproducibility of the results from the new coagulation test
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Other |
Blood sampling from healthy volunteers (20mL)
20 | years-old | <= |
99 | years-old | >= |
Male and Female
(1) Healthy volunteers (n=15)
(2) Patients undergoing an elective cardiac surgery using cardiopulmonary bypass (n=15)
Refusal for obtainment of infromed consent
30
1st name | Tokujiro |
Middle name | |
Last name | Uchida |
Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences
Department of Anesthesiology
113-8510
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
03-5803-5325
uchida.mane@tmd.ac.jp
1st name | Yudai |
Middle name | |
Last name | Yamamoto |
Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences
Department of Anesthesiology
113-8510
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
03-5803-5325
ydaimane@tmd.ac.jp
Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences
Arkray, Inc
Profit organization
Japanese
Tokyo Medical and Dental University
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
03-5803-5325
syomu1.adm@tmd.ac.jp
NO
東京医科歯科大学医学部附属病院(東京都)
2018 | Year | 04 | Month | 01 | Day |
Unpublished
Open public recruiting
2018 | Year | 02 | Month | 26 | Day |
2018 | Year | 04 | Month | 01 | Day |
2018 | Year | 03 | Month | 16 | Day |
2019 | Year | 09 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036038
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