Optimization Strategies for Blood Transfusion Protocols in the Emergency Treatment of Hemorrhagic Shock

Air Force Military Medical University of People's Liberation Army

Status and phase: Not yet enrolling; Phase 3

Conditions: Upper Gastrointestinal Bleeding (UGIB); Hemorrhage; Hemorrhagic Shock

Treatments: Drug: 1:1:1 component transfusion; Drug: ABO- and Rh-compatible whole blood; Drug: low-titer O-group whole blood

Study type: Interventional

Funder types: Other

Identifiers

NCT07129031

KY20252202

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 10 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with hemorrhagic shock due to trauma or upper gastrointestinal bleeding who meet emergency transfusion criteria (hemoglobin < 7 g/dL or active bleeding).

Age 10-90 years. Time from onset to hospital admission < 24 hours.

Exclusion criteria

• Severe underlying diseases (end-stage organ failure or active malignancy). Known coagulopathy or history of severe transfusion reactions. Refusal to participate or inability to complete follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 3 patient groups

group of 1:1:1 component transfusion

Active Comparator group

Description:

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).

Treatment:

Drug: 1:1:1 component transfusion

group of ABO- and Rh-compatible whole blood

Active Comparator group

Description:

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)".

Treatment:

Drug: ABO- and Rh-compatible whole blood

low-titer O-group whole blood

Experimental group

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.

Treatment:

Drug: low-titer O-group whole blood