UMIN-CTR Clinical Trial

Public title

Whole blood transfusion for traumatic hemorrhage: a systematic review and meta-analysis of randomized controlled trials

Acronym

Trauma-WBT RCT SR and MA

Scientific Title

Efficacy and safety of whole blood transfusion compared with blood component therapy in patients with traumatic hemorrhage: a systematic review and meta-analysis of randomized controlled trials

Scientific Title:Acronym

Trauma-WBT RCT SR and MA

Region

Japan	Asia(except Japan)	North America
South America	Australia	Europe
Africa

Condition

Traumatic hemorrhage and hemorrhagic shock

Classification by specialty

Emergency medicine	Blood transfusion	Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate whether a transfusion strategy including whole blood reduces 28- or 30-day all-cause mortality compared with blood component therapy in patients with traumatic hemorrhage or hemorrhagic shock. Secondary objectives are to assess 24-hour all-cause mortality, 24-hour total transfusion requirements, time to hemostasis, re-intervention for bleeding, 24-hour crystalloid volume, ventilator-free days, ICU length of stay, total hospital stay, neurological functional

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

All-cause mortality through day 28 or 30. One time point per trial will be selected in the following order: day 30, day 28, in-hospital death during the index hospitalization, and the longest reported time point within 30 days. In-hospital mortality will remain eligible when hospitalization exceeds 30 days; sensitivity analyses will separately use only 28- to 30-day mortality and only in-hospital mortality.

Key secondary outcomes

1) All-cause mortality within 24 hours (and 6 hours) after randomization; 2) 24-hour total transfusion requirements (units of RBC, plasma, platelets, or total volume); 3) time to hemostasis and re-intervention for bleeding; 4) 24-hour total crystalloid volume; 5) ventilator-free days through day 28 (assigning zero to deaths within 28 days); 6) ICU length of stay and total hospital stay; 7) favorable neurological functional outcome at day 30 or 6 months (GOSE >= 5 or mRS 0-2); 8) thromboembolic events (pulmonary embolism, deep vein thrombosis, stroke, myocardial infarction); 9) transfusion-related adverse events (TRALI, TACO, acute hemolytic reaction); and 10) multiple organ failure, sepsis, ARDS, and participants with at least one serious adverse event (SAE) through discharge or day 30. Outcomes will be pooled only when their definitions and assessment times are clinically comparable; otherwise, they will be presented narratively.

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Individual- or cluster-randomized parallel-group controlled trials enrolling adult or pediatric patients with acute traumatic hemorrhage or hemorrhagic shock resulting from trauma (excluding burns), defined by individual trials through active bleeding, hypotension, elevated shock index, activation of massive transfusion protocols, or clinical requirement for emergent blood transfusion. The intervention must be any transfusion strategy including whole blood (such as cold-stored low-titer group O whole blood [LTOWB], type-specific whole blood, fresh whole blood, or modified whole blood), and the comparator must be blood component therapy without whole blood (such as 1:1:1 component protocols). No restriction will be placed on injury mechanism (blunt or penetrating), presence of traumatic brain injury, severity, setting of transfusion initiation (prehospital or in-hospital), country, language, or publication status.

Key exclusion criteria

Non-randomized studies, quasi-randomized studies using predictable allocation (e.g., alternation, medical record or patient numbers, birth dates, admission dates), crossover trials, and animal or healthy-volunteer studies; non-traumatic hemorrhage (e.g., gastrointestinal bleeding, obstetric hemorrhage, ruptured aortic aneurysm, elective perioperative bleeding) and isolated burn injury; mixed-population studies without separable trauma data; studies using autologous transfusion only; trials comparing different storage durations of whole blood where both groups receive whole blood; and duplicate reports of the same trial, which will be linked as one trial family.

Target sample size

3000

Name of lead principal investigator

1st name	KOHEI
Middle name
Last name	AOYAMA

Organization

Osaka Medical and Pharmaceutical University

Division name

Department of Emergency and Critical Care Medicine, Faculty of Medicine

Zip code

5698686

Address

2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan

TEL

072-683-1221

Email

kohei.aoyama@ompu.ac.jp

Name of contact person

1st name	KOHEI
Middle name
Last name	AOYAMA

Organization

Osaka Medical and Pharmaceutical University

Division name

Department of Emergency and Critical Care Medicine, Faculty of Medicine

Zip code

5698686

Address

2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan

TEL

072-683-1221

Homepage URL

Email

kohei.aoyama@ompu.ac.jp

Institute

Osaka Medical and Pharmaceutical University

Institute

Department

Personal name

KOHEI AOYAMA

Organization

Self-Founding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Osaka Medical and Pharmaceutical University

Address

2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan

Tel

072-683-1221

Email

kohei.aoyama@ompu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

09

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

09

Month

01

Day

Date of IRB

Anticipated trial start date

2026

Year

09

Month

01

Day

Last follow-up date

2026

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2027

Year

03

Month

31

Day

Other related information

This systematic review and meta-analysis is restricted to RCTs comparing whole blood transfusion with blood component therapy in traumatic hemorrhage (preliminary candidates: Cotton 2013, TROOP, SWiFT, TOWAR, WEBSTER; final numbers to follow updated search). MEDLINE, Embase, and CENTRAL will be searched from inception without language limits, alongside forward/backward citation chasing. Studies labeled randomized without allocation details will be provisionally eligible and assessed via RoB 2 unless proven quasi-random. Discrepancies across registries and reports will be linked by trial family. Two reviewers will independently perform study selection, data extraction, RoB 2 assessment, and GRADE certainty evaluation; disagreements will be resolved by discussion or a third reviewer.
Dichotomous and continuous outcomes will be reported as risk ratios (RRs) and mean differences (MDs) with 95% CIs. Medians/IQRs will be converted to means/SDs via Wan and Luo methods. If >=2 homogeneous trials exist, a random-effects model (REML) will be the primary analysis, with common-effect models for sensitivity. Hartung-Knapp CIs will be used if >=3 trials and tau-squared > 0. Heterogeneity will be evaluated via tau-squared, I-squared, Cochran Q, and clinical/methodological diversity.
Pre-specified subgroup analyses (using interaction tests) include: 1) setting (prehospital vs in-hospital), 2) mechanism (blunt vs penetrating), 3) TBI presence, 4) WB dose (low vs high dose), and 5) risk of bias (low risk vs some concerns/high risk). Sensitivity analyses will test mortality definitions (28-30-day only vs in-hospital only), statistical models (random-effects vs common-effect), and low RoB trials.
All stages will be managed in Clarion Evidence Studio. AI will not serve as an independent reviewer; source anchors, rationales, change histories, and audit exports will be preserved.

Registered date

2026

Year

08

Month

26

Day

Last modified on

2026

Year

08

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071786