UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059948 |
|---|---|
| Receipt number | R000068569 |
| Scientific Title | Effectiveness of Whole Blood Transfusion in Adult Patients with Traumatic Brain Injury: A Systematic Review and Meta-Analysis |
| Date of disclosure of the study information | 2025/12/08 |
| Last modified on | 2025/12/02 15:52:32 |
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Basic information
Public title
Effectiveness of Whole Blood Transfusion in Adult Patients with Traumatic Brain Injury: A Systematic Review and Meta-Analysis
Acronym
Effectiveness of Whole Blood Transfusion in Adult Patients with Traumatic Brain Injury
Scientific Title
Effectiveness of Whole Blood Transfusion in Adult Patients with Traumatic Brain Injury: A Systematic Review and Meta-Analysis
Scientific Title:Acronym
Effectiveness of Whole Blood Transfusion in Adult Patients with Traumatic Brain Injury: A Systematic Review and Meta-Analysis
Region
| Japan |
Condition
Condition
traumatic brain injury
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Balanced transfusion, in which plasma, platelets, and red blood cells are administered in fixed ratios, have been widely adopted as a standard approach for patients with severe trauma. In contrast, whole blood transfusion containing platelets has recently been evaluated as emerging evidence suggests a potential survival benefit in patients with traumatic hemorrhagic shock, particularly in the United States. However, most of these findings are derived from studies focusing on polytrauma, and the effectiveness of whole blood transfusion in patients with traumatic brain injury remains unclear.
This study aims to systematically identify and synthesize the existing literature on whole blood transfusion in patients with traumatic brain injury, and to evaluate its clinical effectiveness and safety through a systematic review and meta-analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mortality
Key secondary outcomes
1. Total transfusion volume (red blood cells, fresh frozen plasma, and platelet concentrates)
2. Complications: thrombosis (pulmonary embolism, deep vein thrombosis), acute kidney injury, pulmonary edema, acute respiratory distress syndrome, and infection
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 16 years or older with traumatic brain injury will be included. A comprehensive literature search will be conducted to capture a wide range of relevant studies. The characteristics of the retrieved studies will then be examined to ensure clinical and methodological consistency across patient populations, after which eligible studies will be selected for inclusion in the meta-analysis. Studies that do not meet the eligibility criteria but are considered relevant will be summarized narratively.
Key exclusion criteria
1. Studies not involving human subjects
2. Pediatric cases (patients younger than 16 years)
3. Subgroup analyses in which no traumatic brain injury cases are included
4. Single-arm studies, case reports, conference abstracts, or protocol-only publications
5. Articles not written in English
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Tatsunori |
| Middle name | |
| Last name | Nagamura |
Organization
National Defense Medical College
Division name
Traumatology and Critical Care Medicine
Zip code
3590042
Address
3-2 Namiki, Tokorozawa, Saitama
TEL
81-4-2995-1511
tnaga0802@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | Tatsunori |
| Middle name | |
| Last name | Nagamura |
Organization
National Defense Medical College
Division name
Traumatology and Critical Care Medicine
Zip code
3590042
Address
3-2 Namiki, Tokorozawa, Saitama
TEL
81-4-2995-1511
Homepage URL
tnaga0802@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
self funding
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
National Defense Medical College
Address
3-2 Namiki, Tokorozawa, Saitama
Tel
81-4-2995-1511
tnaga0802@ndmc.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
| 2025 | Year | 12 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study population and selection:
Adults (16 years or older) with traumatic brain injury will be included. A comprehensive literature search will be conducted to identify relevant studies. Retrieved studies will be assessed for clinical and methodological consistency, and eligible studies will be included in the meta-analysis. Studies not meeting eligibility criteria but deemed relevant will be narratively summarized.
PICO:
Patient: 16 years or older with traumatic brain injury
Intervention: at least one unit of whole blood transfusion
Comparison: No whole blood transfusion
Outcome: Mortality
Study designs:
Randomized controlled trials and observational studies will be included. Observational studies must adjust for confounding (e.g., propensity score matching or inverse probability of treatment weighting).
Search strategy:
Searches will be performed in PubMed, CENTRAL, CINAHL, ICTRP, and ClinicalTrials.gov for studies published from January 1, 2006, to December 31, 2025.
Data extraction and risk of bias:
Two reviewers will independently extract data (authors, year, design, sample size, intervention/comparator details, outcomes). Risk of bias will be assessed using RoB 2 for RCTs and ROBINS-I for observational studies.
Statistical analysis:
Binary outcomes will be reported as risk ratios with 95% CIs; continuous outcomes as mean differences.
Planned subgroup analyses include:
1. TBI severity based on the Abbreviated Injury Scale (AIS) and Glasgow Coma Scale (GCS)
2. Presence versus absence of hemorrhagic shock
Management information
Registered date
| 2025 | Year | 12 | Month | 02 | Day |
Last modified on
| 2025 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068569
