UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010238 |
|---|---|
| Receipt number | R000010871 |
| Scientific Title | Evaluation of the coagulability of preserved autologous whole blood using Rotation thromboelastometry |
| Date of disclosure of the study information | 2013/03/13 |
| Last modified on | 2020/09/16 19:07:05 |
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Basic information
Public title
Evaluation of the coagulability of preserved autologous whole blood using Rotation thromboelastometry
Acronym
Evaluation of the coagulability of preserved autologous whole blood using ROTEM®
Scientific Title
Evaluation of the coagulability of preserved autologous whole blood using Rotation thromboelastometry
Scientific Title:Acronym
Evaluation of the coagulability of preserved autologous whole blood using ROTEM®
Region
| Japan |
Condition
Condition
ischemic heart disease,valvular disease, aortic aneurysm,congenital congenital heart disease
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluation of the coagulability of preserved autologous whole blood
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ROTEM(INTEM, EXTEM, FIBTEM)
Clotting time(CT), Clot formation time (CFT),Alpha angle,A10,Maximum clot firmness,LY30, 45, 60,ML,fibrinogen
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Above 20 years old patients who undergo elective cardiac surgery.
2.The patients who are obtained informed concent for preserved autologous whole blood.
Key exclusion criteria
1.Refusal to participate in this study.
2.Emergency operation.
3.Taking warfarin.
4.The researcher decided that the patient who are inappropriate.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ozaki |
Organization
Tokyo Women's Medical University Hospital
Division name
Anesthesiology
Zip code
162-8666
Address
8-1 Kawadacho, Shinjkuku-ku Tokyo
TEL
03-5269-7336
morton@live.jp
Public contact
Name of contact person
| 1st name | Shihoko |
| Middle name | |
| Last name | Iwata |
Organization
Tokyo Women's Medical University Hospital
Division name
Anesthesiology
Zip code
162-8666
Address
8-1 Kawadacho, Shinjkuku-ku Tokyo
TEL
03-3353-8111
Homepage URL
shk_wt_0204@ybb.ne.jp
Sponsor or person
Institute
Tokyo Women's Medical University Hospital
Department of anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University Hospital
Department of anesthesiology
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
Tokyo Women's Medical University Hospital
Address
8-1 Kawadacho, Shinjkuku-ku Tokyo
Tel
03-3353-8111
krinri.bm@twmu.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
| 2013 | Year | 03 | Month | 13 | 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
| 2012 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of the coagulability of preserved autologous whole blood using Rotation thromboelastometry.
Main items of INTEM,EXTEM,FIBTEM are CT,CFT,MCF etc.
Management information
Registered date
| 2013 | Year | 03 | Month | 13 | Day |
Last modified on
| 2020 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010871
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
