UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037138 |
|---|---|
| Receipt number | R000042324 |
| Scientific Title | A pilot study; The relationship between blood test during cardiopulmonary bypass and coagulation function evaluated by thromboelastometry after taking off cardiopulmonary bypass. |
| Date of disclosure of the study information | 2019/07/05 |
| Last modified on | 2024/12/24 12:56:45 |
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Basic information
Public title
A pilot study; The relationship between blood test during cardiopulmonary bypass and coagulation function evaluated by thromboelastometry after taking off cardiopulmonary bypass.
Acronym
A pilot study; The relationship between blood test during cardiopulmonary bypass and coagulation function evaluated by thromboelastometry after taking off cardiopulmonary bypass.
Scientific Title
A pilot study; The relationship between blood test during cardiopulmonary bypass and coagulation function evaluated by thromboelastometry after taking off cardiopulmonary bypass.
Scientific Title:Acronym
A pilot study; The relationship between blood test during cardiopulmonary bypass and coagulation function evaluated by thromboelastometry after taking off cardiopulmonary bypass.
Region
| Japan |
Condition
Condition
Patients who receive cardiac surgery
Classification by specialty
| Anesthesiology | Cardiovascular surgery | Blood transfusion |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
appropriate blood transfusion management
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
difference in coagulation ability depending on the administration period
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Blood transfusion is used during CPB.
Interventions/Control_2
Blood transfusion is used after CPB.
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
| 15 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
cases of cardiac surgery
Key exclusion criteria
none
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Tamura |
Organization
Nagoya University Hospital
Division name
Department of Anesthesiology
Zip code
4668550
Address
Tsurumai-cho 65, Showa-ku, Nagoya, Aichi, JAPAN
TEL
0527412111
takahiro@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Tamura |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
466-8550
Address
Tsurumai-cho 65, Showa-ku, Nagoya, Aichi, JAPAN
TEL
0527412111
Homepage URL
takahiro@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Nagoya University hospital
Address
Tsurumai-cho 65, Showa-ku, Nagoya, Aichi, JAPAN
Tel
0527412111
ethics@med.nagoya-u.ac.j
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
| 2019 | Year | 07 | Month | 05 | 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
| 2019 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2019 | Year | 06 | Month | 22 | Day |
Last modified on
| 2024 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042324
