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NCT Number: NCT07129031

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

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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Key information

Age range

10 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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)".

Primary outcomes

  1. survival rate

    Time frame: 24 hours,30 days

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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