NCT07129031

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 10 Years – 90 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)".

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2025-08-19
• Last updated: 2025-08-19

Locations

1 site across 1 country: China