UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057991 |
|---|---|
| Receipt number | R000066179 |
| Scientific Title | Transfusion as hemostasis-optimized strategies in patients with traumatic hemorrhagic shock: a systematic review and meta-analysis |
| Date of disclosure of the study information | 2025/05/28 |
| Last modified on | 2025/05/28 22:49:48 |
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Basic information
Public title
Transfusion as hemostasis-optimized strategies in patients with traumatic hemorrhagic shock: a systematic review and meta-analysis
Acronym
Transfusion as hemostasis-optimized strategies in patients with traumatic hemorrhagic shock: a systematic review and meta-analysis
Scientific Title
Transfusion as hemostasis-optimized strategies in patients with traumatic hemorrhagic shock: a systematic review and meta-analysis
Scientific Title:Acronym
Transfusion as hemostasis-optimized strategies in patients with traumatic hemorrhagic shock: a systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Traumatic Hemorrhagic Shock
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This systematic review defines the intervention group as hemostasis-optimized transfusion strategies for patients with traumatic hemorrhagic shock and the control group as conventional transfusion strategies. A sensitivity analysis including a no-transfusion group will also be conducted, and two separate meta-analyses will be performed
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall mortality, Short-term mortality, Achievement of hemostasis, Major adverse events (e.g., TACO, TRALI)
Key secondary outcomes
Hospital/ICU length of stay, Organ failure, Volume of fluids and blood transfusion
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Studies on traumatic hemorrhagic shock
Key exclusion criteria
Studies with inappropriate designs
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yamamoto |
| Middle name | |
| Last name | Ryo |
Organization
Keio University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
ryoyamamoto@keio.jp
Public contact
Name of contact person
| 1st name | Yamamoto |
| Middle name | |
| Last name | Ryo |
Organization
Keio University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Homepage URL
ryoyamamoto@keio.jp
Sponsor or person
Institute
Keio University School
Institute
Department
Personal name
Funding Source
Organization
The Japanese Association for the Surgery of Trauma
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
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
Tel
03-3353-1211
ryoyamamoto@keio.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
| 2025 | Year | 05 | Month | 28 | 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
0
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
| 2025 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a systematic review and meta-analysis evaluating the effectiveness of transfusion strategies optimized for hemostasis in patients with traumatic hemorrhagic shock. The intervention group includes strategies such as early administration of coagulation factor concentrates and transfusion guided by real-time coagulation monitoring (e.g., TEG or ROTEM), while the control group includes conventional red blood cell-dominant transfusion strategies. Sensitivity analysis including a no-transfusion control group will also be conducted. The primary outcomes are all-cause mortality and short-term mortality. Secondary outcomes include hospital/ICU length of stay, organ failure, achievement of hemostasis, serious adverse events, and volume of fluids/blood products transfused. Subgroup and sensitivity analyses (e.g., inclusion of whole blood transfusion, exclusion of studies with no transfusion in the control group) will be performed to assess the robustness of treatment effects.As this is not a clinical trial, certain fields in the UMIN form (e.g., intervention, number of groups, trial design) are completed for administrative purposes only.
Management information
Registered date
| 2025 | Year | 05 | Month | 27 | Day |
Last modified on
| 2025 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066179
