UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043036 |
|---|---|
| Receipt number | R000049129 |
| Scientific Title | Effectiveness of cold platelet for trauma and cardiovascular surgery |
| Date of disclosure of the study information | 2021/01/18 |
| Last modified on | 2021/11/13 16:46:02 |
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Basic information
Public title
Effectiveness of cold platelet for trauma and cardiovascular surgery. Prospective study for massive bleeding patients using point of care coagulation test by ex vivo.
Acronym
Effectiveness of cold platelet for trauma and cardiovascular surgery
Scientific Title
Effectiveness of cold platelet for trauma and cardiovascular surgery
Scientific Title:Acronym
Effectiveness of cold platelet for trauma and cardiovascular surgery
Region
| Japan |
Condition
Condition
trauma, cardiovascular surgery
Classification by specialty
| Vascular surgery | Anesthesiology | Cardiovascular surgery |
| Emergency medicine | Blood transfusion |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As a preliminary study to determine whether cold platelets are clinically practical and whether these platelets concentrates are effective for massive bleeding cases including trauma and cardiovascular surgery. We plan to compare two types of platelet concentrates stored room temperature or fridge (4 celcius degree).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparing platelet function using point of care viscoelastic device and the other tests.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Trauma or cardiovascular cases predicted to transfuse platelet concentrate.
Key exclusion criteria
Patients without informed consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mitsuharu |
| Middle name | |
| Last name | Kodaka |
Organization
Tokyo women's medical university
Division name
Medical center east, anesthesiology
Zip code
116-8567
Address
2-1-10 Nishiogu Arakawa-ku, 116-8567 Tokyo
TEL
03-3810-1111
kmkodaka@cb3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Mitsuharu |
| Middle name | |
| Last name | Kodaka |
Organization
Tokyo women's medical university
Division name
Medical center east, anesthesiology
Zip code
116-8567
Address
2-1-10 Nishiogu Arakawa-ku, 116-8567 Tokyo
TEL
03-3810-1111
Homepage URL
kmkodaka@cb3.so-net.ne.jp
Sponsor or person
Institute
Tokyo women's medical university
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Tokyo women's medical university
Address
8-1 Kawada-cho Sinjyuku-ku Tokyo
Tel
03-3353-8111
http://www.twmu.ac.jp/RINRI/mokuteki.html
Secondary IDs
Secondary IDs
YES
Study ID_1
2020-38
Org. issuing International ID_1
IRB of TWMU
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 18 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparing platelet function using point of care viscoelastic device and the other tests.
Management information
Registered date
| 2021 | Year | 01 | Month | 17 | Day |
Last modified on
| 2021 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049129
| 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 |
