UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057842 |
|---|---|
| Receipt number | R000066014 |
| Scientific Title | Tranexamic Acid in Patients with Traumatic Hemorrhagic Shock: A Systematic Review and Meta-analysis |
| Date of disclosure of the study information | 2025/05/12 |
| Last modified on | 2025/05/14 10:57:55 |
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Basic information
Public title
Tranexamic Acid in Patients with Traumatic Hemorrhagic Shock: A Systematic Review and Meta-analysis
Acronym
Tranexamic Acid in Patients with Traumatic Hemorrhagic Shock: A Systematic Review and Meta-analysis
Scientific Title
Tranexamic Acid in Patients with Traumatic Hemorrhagic Shock: A Systematic Review and Meta-analysis
Scientific Title:Acronym
Tranexamic Acid in Patients with Traumatic Hemorrhagic Shock: A Systematic Review and Meta-analysis
Region
| Japan |
Condition
Condition
Traumatic Hemorrhagic Shock Patients
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the Efficacy and Safety of Tranexamic Acid in Traumatic Hemorrhagic Shock Patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional Outcome
Key secondary outcomes
Adverse Event
Total Blood Product Usage
ICU Length of Stay
Hospital Length of Stay
Short-term Mortality
Long-term Mortality
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Randomized controlled trial including more than 50% of patients with traumatic hemorrhagic shock
Key exclusion criteria
Conference abstract
Language other than English
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Nobuto |
| Middle name | |
| Last name | Nakanishi |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Disaster and Emergency Medicine, Department of Surgery Related
Zip code
650-0017
Address
7-5-2 Kusunoki, Chuo-ward, Kobe, 650-0017, Japan
TEL
0783826521
nobuto_nakanishi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Nobuto |
| Middle name | |
| Last name | Nakanishi |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Disaster and Emergency Medicine, Department of Surgery Related
Zip code
650-0017
Address
7-5-2 Kusunoki, Chuo-ward, Kobe, 650-0017, Japan
TEL
0783826521
Homepage URL
nobuto_nakanishi@yahoo.co.jp
Sponsor or person
Institute
Kobe university
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
Kobe University Graduate School of Medicine
Address
7-5-2 Kusunoki, Chuo-ward, Kobe, 650-0017, Japan
Tel
078-382-6521
nobuto_nakanishi@yahoo.co.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
兵庫県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 12 | Day |
Related information
URL releasing protocol
https://www.dropbox.com/scl/fi/icvxruarrz324b0606hil/3_protcol_link-to-umine_20250514.pdf?rlkey=quxq
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 | 12 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 12 | 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; therefore, no patient enrollment is required.
Subgroup analyses will be performed based on the following factors: (1) timing of tranexamic acid administration, (2) dosage of tranexamic acid, and (3) site of trauma.
Management information
Registered date
| 2025 | Year | 05 | Month | 12 | Day |
Last modified on
| 2025 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066014
