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This single-center, prospective, randomized controlled trial was approved by the institutional ethics committee and overseen by an independent data and safety monitoring board. It enrolled patients with hemorrhagic shock caused by trauma or major gastrointestinal bleeding. Using a random-number-table method, participants were allocated to three groups: (1) Control group: standard massive transfusion protocol (MTP) with transfusing type-specific blood components in a 1:1:1 ratio. (2) Type-specific whole-blood group: following emergency ABO typing and cross-matching, type-specific whole blood was transfused. (3) Low-titer group O whole-blood group: in the emergency phase, 4 units of low-titer group O whole blood (anti-A/B IgM titer < 1:64) were infused; after definitive ABO typing, patients were switched to type-specific whole blood. Clinical data were automatically extracted from the electronic medical record system. Primary endpoints were efficacy (28-day survival), timeliness (transfusion waiting time and time to achieve target mean arterial pressure), cost-effectiveness (total blood consumption and transfusion-related expenses), and safety (transfusion-associated adverse events including TRALI and hemolytic reactions).Statistical analyses included Kaplan-Meier survival curves and Cox proportional-hazards regression, adjusting for confounders such as age and disease severity scores. The advantages and disadvantages of each transfusion strategy were evaluated, and an optimized strategy for emergency blood transfusion in hemorrhagic shock was developed. This strategy was peer-reviewed and refined, culminating in a standardized, multidisciplinary, emergency-transfusion protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group of 1:1:1 component transfusion | Active Comparator | Following the "Chinese Expert Consensus on Emergency Blood Support Models and Transfusion Strategies for Severely Injured Patients (2024 Edition)", implement the massive transfusion protocol (MTP) by transfusing type-specific blood components in a 1:1:1 ratio (red blood cells : plasma : platelets). |
|
| group of ABO- and Rh-compatible whole blood | Active Comparator | Administer type-specific whole-blood transfusion in accordance with the "Chinese Expert Consensus on Emergency Blood Support Models and Transfusion Strategies for Severely Injured Patients (2024 Edition)". |
|
| low-titer O-group whole blood | Experimental | During the emergency phase, administer 4 units of low-titer group O whole blood (anti-A/B IgM antibody titer < 1:64); once the patient's blood type is determined, switch to type-specific whole blood. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-titer O-group whole blood | Drug | Arm Description: During the emergency phase, administer 4 units of low-titer group O whole blood (anti-A/B IgM antibody titer < 1:64); once the patient's blood type is determined, switch to type-specific whole blood. |
| Measure | Description | Time Frame |
|---|---|---|
| survival rate | 24 hours,30 days |
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Inclusion Criteria:
Age 10-90 years. Time from onset to hospital admission < 24 hours.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| lijunjie li | Xijing Hospital | Study Director |
| liushanshou liu | Xijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Xi'an | Shannxi | 710032 | China |
The following de-identified individual participant data (IPD) will be shared via a public repository (Dryad Digital Repository) no later than 12 months after the primary results publication.
Participant-level baseline characteristics
• Age, sex, body-mass index, Injury Severity Score (ISS), baseline hemoglobin, vital signs on arrival, coagulation parameters (INR, platelet count, fibrinogen), lactate.
Intervention allocation and delivery data • Randomization group, actual blood products transfused (type, volume, sequence, total units), time from randomization to first transfusion.
Primary and secondary outcomes (28-day follow-up)
Safety events
• All-grade and grade ≥3 ad
January 2026-January 2028
1. The IPD and supporting information will be accessible to the following parties:
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| 1:1:1 component transfusion | Drug | Following the "Chinese Expert Consensus on Emergency Blood Support Models and Transfusion Strategies for Severely Injured Patients (2024 Edition)", implement the massive transfusion protocol (MTP) by transfusing type-specific blood components in a 1:1:1 ratio (red blood cells : plasma : platelets). |
|
| ABO- and Rh-compatible whole blood | Drug | Administer type-specific whole-blood transfusion in accordance with the "Chinese Expert Consensus on Emergency Blood Support Models and Transfusion Strategies for Severely Injured Patients (2024 Edition)". |
|
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D012771 | Shock, Hemorrhagic |
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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