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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000027870
Receipt No. 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

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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
Email 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
Email ke-rskk@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University School of Medicine
Institute
Department

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
Email 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
URL(English) 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
Registered date File name

Research case data
Registered date File name


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