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

Summary

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.

Conditions

• Hemorrhage
• Hemorrhagic Shock
• Upper Gastrointestinal Bleeding (UGIB)

Interventions

DRUG

low-titer O-group whole blood

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.

DRUG

1:1:1 component transfusion

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).

DRUG

ABO- and Rh-compatible whole blood

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)".

Sponsors & Collaborators

• Xijing Hospital

  lead OTHER

Principal Investigators

• lijunjie li · Xijing Hospital

• liushanshou liu · Xijing Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2027-06-30

Completion

2027-12-31

Countries

• China

Study Locations