UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027921 |
|---|---|
| Receipt number | R000031982 |
| Scientific Title | Comparison of Sonoclot and TEG6s in adult elective cardiac surgery : a prospective observational study |
| Date of disclosure of the study information | 2017/06/26 |
| Last modified on | 2019/09/13 16:53:04 |
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Basic information
Public title
Comparison of Sonoclot and TEG6s in adult elective cardiac surgery : a prospective observational study
Acronym
Comparison of Sonoclot and TEG6s in adult elective cardiac surgery : a prospective observational study
Scientific Title
Comparison of Sonoclot and TEG6s in adult elective cardiac surgery : a prospective observational study
Scientific Title:Acronym
Comparison of Sonoclot and TEG6s in adult elective cardiac surgery : a prospective observational study
Region
| Japan |
Condition
Condition
cardiac surgery
Classification by specialty
| Cardiovascular surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Consider the correlation between the results obtained by conventional coagulation blood test and the measurement results of Sonoclot and TEG 6s.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between the results obtained by conventional coagulation blood test and the measurement results of Sonoclot and TEG 6s
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who undergo elective cardiac surgery
Patients who are 18 years of age or older
Patients who are given written consent by the patient's free will with sufficient understanding
Patients who undergo surgery using heart-lung machine
Key exclusion criteria
Patients who are using antiplatelet drugs or anticoagulants before surgery and are not adequately stopped
Cases with extremely difficult hemostasis, such as using heart-lung machine for more than 6 hours
Patients using intra-aortic balloon pumping (IABP) or percutaneous cardiopulmonary assist device (PCPS)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Okazaki |
Organization
The university of Tokyo hospital
Division name
Department of Blood transfusion
Zip code
113-0033
Address
7-3-1 Hongo Bukyo ward Tokyo Japan
TEL
03-3815-5411
okazakih-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | RUI |
| Middle name | |
| Last name | Terada |
Organization
The university of Tokyo hospital
Division name
Department of Blood transfusion
Zip code
113-0033
Address
7-3-1 Hongo Bukyo ward Tokyo Japan
TEL
03-3815-5411
Homepage URL
teradar-tky@umin.ac.jp
Sponsor or person
Institute
The university of Tokyo hospital
Department of Blood transfusion
Institute
Department
Personal name
Funding Source
Organization
The Japan society of transfusion medicine and cell therapy
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The university of Tokyo hospital
Address
7-3-1 Hongo Bunkyo Tokyo
Tel
03-3815-5411
golder819917@yahoo.co.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 26 | 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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 09 | Month | 06 | Day |
Other
Other related information
Nothing particular
Management information
Registered date
| 2017 | Year | 06 | Month | 25 | Day |
Last modified on
| 2019 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031982
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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