UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027870 |
|---|---|
| Receipt number | R000031933 |
| Scientific Title | Sonoclot and TEG6s guided transfusion therapy for preoperative point of care monitoring |
| Date of disclosure of the study information | 2017/06/23 |
| Last modified on | 2021/06/26 09:29:56 |
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Basic information
Public title
Sonoclot and TEG6s guided transfusion therapy for preoperative point of care monitoring
Acronym
Sonoclot and TEG6s guided transfusion therapy for preoperative point of care monitoring
Scientific Title
Sonoclot and TEG6s guided transfusion therapy for preoperative point of care monitoring
Scientific Title:Acronym
Sonoclot and TEG6s guided transfusion therapy for preoperative point of care monitoring
Region
| Japan |
Condition
Condition
The patients who are planned to undergone open heart surgery
Classification by specialty
| Anesthesiology | Cardiovascular surgery | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purposes are the establishment to appropriate utilization to blood products and point of care monitoring guided transfusion therapy which is quick and high reliable.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the numbers of order of fresh frozen products and platelets, and the amount of blood transfusion of that
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The patients who are planned to perform Sonoclot guided blood transfusion
This study will be examined from preoperative days to the first postoperative day.
Interventions/Control_2
The patients who are planned to perform Sonoclot and TEG6s guided blood transfusion
This study will be examined from preoperative days to the first postoperative day.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients who are planned to perform open heart surgery.
Key exclusion criteria
The patients who are difficult of mutual understanding and not be obtained consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Mitsutaka |
| Middle name | |
| Last name | Edanaga |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
060-8543
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
edanaka@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Asami |
| Middle name | |
| Last name | Nakano |
Organization
Sapporo Medical University School of Medicine
Division name
clinical study section of secretariat
Zip code
060-8543
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
ke-rskk@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Blood Products Organization
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University School of Medicine
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
Tel
011-611-2111
ke-rskk@sapmed.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 23 | 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 | 06 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 22 | Day |
Last modified on
| 2021 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031933
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
