UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019047 |
|---|---|
| Receipt number | R000022023 |
| Scientific Title | The prospective single institute cohort study of massive transfusion protocol in severe trauma |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2015/10/01 20:05:42 |
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Basic information
Public title
The prospective single institute cohort study of massive transfusion protocol in severe trauma
Acronym
The study of massive transfusion protocol in severe trauma
Scientific Title
The prospective single institute cohort study of massive transfusion protocol in severe trauma
Scientific Title:Acronym
The study of massive transfusion protocol in severe trauma
Region
| Japan |
Condition
Condition
severe trauma
Classification by specialty
| Surgery in general | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the efficacy and safety of massive transfusion protocol in severe trauma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The amount of blood transfusion during primary treatment and hospitalization.
The mortality rate.
Key secondary outcomes
The time from an accident to CT scan, exercising the protocol, transfusing initial RBC or FFP.
The rate of complications.
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All trauma patients transfered to emergency department of Osaka University Hospital.
Key exclusion criteria
The case transfered from another hospital.
Pediatrics under 12 years old.
Target sample size
650
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mituo Ohnishi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Traumatology and Acute Critical Medicine
Zip code
Address
2-15, Suita, Osaka
TEL
06-6879-5707
mohnishi@hp-emerg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Ojima |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Traumatology and Acute Critical Medicine
Zip code
Address
2-15, Suita, Osaka
TEL
06-6879-5707
Homepage URL
ojimarionet999@hp-emerg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Traumatology and Acute Critical Medicine, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大阪大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will report the results in a paper or medical conferences.
Management information
Registered date
| 2015 | Year | 09 | Month | 16 | Day |
Last modified on
| 2015 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022023
| 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 |
