UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020920 |
|---|---|
| Receipt number | R000024121 |
| Scientific Title | Clinical evaluation of dielectric blood coagulometry: observational study |
| Date of disclosure of the study information | 2016/02/08 |
| Last modified on | 2018/09/04 14:36:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical evaluation of dielectric blood coagulometry: observational study
Acronym
Clinical evaluation of dielectric blood coagulometry
Scientific Title
Clinical evaluation of dielectric blood coagulometry: observational study
Scientific Title:Acronym
Clinical evaluation of dielectric blood coagulometry
Region
| Japan |
Condition
Condition
Patients undergoing cardiovascular surgery using cardiopulmonary bypass
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare clinical performances of dielectric coagulometer with thromboelastograph and laboratory based blood coagulation tests.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between dielectric blood coagulometry and thromboelastography/laboratory based blood coagulation tests.
Key secondary outcomes
Correlation between dielectric blood coagulometry and factors related with thrombosis.
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 Cardiovascular surgery using cardiopulmonary bypass
Key exclusion criteria
1.Patients reated with hemodialysis before surgery
2.Patients with previous history of cardiovascular surgery.
3.Patients who refuse obtainment of informed consent.
Target sample size
100
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
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
pocanalysis-group@umin.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Tokyo Medical and Dental University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Sony Corporation
Name of secondary funder(s)
Sony Corporation
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 02 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 08 | 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 100 patients undergoing cardiovascular surgery using cardiopulmonary bypass.
Results from dielectric blood coagulometry are compared with those from thromboelastography(CK, CRT, CKH, CFF)and rotational thromboelastometry (EXTEM, INTEM, FIBTEM, HEPTEM, and APTEM), laboratory based blood coagulation tests(PT, APTT, Fibrinogen, FDP, AT-III), and inflammatory biomarkers, which can be related with coagulation abnormality.
Samples are collected following points.
(1) after induction of anesthesia
(2) end of cardiopulmonary bypass (after protamine administration)
(3) one hour after the end of cardiopulmonary bypass
(4) two hours after the end of cardiopulmonary bypass
(5) end of surgery
Management information
Registered date
| 2016 | Year | 02 | Month | 07 | Day |
Last modified on
| 2018 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024121
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
