UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035992 |
|---|---|
| Receipt number | R000040997 |
| Scientific Title | Cluster randomized crossover non-inferiority trial by limiting blood transfusion for sever trauma patients |
| Date of disclosure of the study information | 2019/02/25 |
| Last modified on | 2022/03/04 19:43:09 |
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Basic information
Public title
Cluster randomized crossover non-inferiority trial by limiting blood transfusion for sever trauma patients
Acronym
The efficacy of limiting transfusion for sever trauma patients
Scientific Title
Cluster randomized crossover non-inferiority trial by limiting blood transfusion for sever trauma patients
Scientific Title:Acronym
The efficacy of limiting transfusion for sever trauma patients
Region
| Japan |
Condition
Condition
sever trauma patients
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For determining whether the limiting of transfusion influence the survival, the total transfusion, organ failure for trauma patients, compared to the group of targeting high hemoglobin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the survival rate after 28 days
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
the volume of transfusion
Interventions/Control_2
The target hemoglobin index
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who had critical trauma and were beyond control for life support without transfusion
Key exclusion criteria
1 cardiopulmonary arrest on admission
2 changing hospital before admission
3 The patients who were not attempting proceeding cure
4 Sever flame burn
5 pregnacy
6 chronic anemia
7 rejection for transfusion
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuhei |
| Middle name | |
| Last name | Irie |
Organization
Fukuoka University hospital
Division name
The department of emergency and critical care
Zip code
8140133
Address
1-45-7 Nanakuma Jhonanku Fukuoka city
TEL
09045170436
iriey@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuhei |
| Middle name | |
| Last name | Irie |
Organization
Fukuoka University hospital
Division name
The department of emergency and critical care
Zip code
8140133
Address
1-45-7 Nanakuma Jhonanku Fukuoka city
TEL
09045170436
Homepage URL
iriey@fukuoka-u.ac.jp
Sponsor or person
Institute
Hokkaido University hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
1980
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University
Address
Fukuoka University Hospital 7-45-1
Tel
092-801-1011
iriey@fukuoka-u.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
| 2019 | Year | 02 | Month | 25 | 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
| 2019 | Year | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 01 | 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 | 02 | Month | 24 | Day |
Last modified on
| 2022 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040997
| Research Plan | |
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| 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 |
