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临床试验/NCT07129031
NCT07129031尚未招募3 期

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

Xijing Hospital1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
180
试验地点
1
主要终点
survival rate

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
10 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: low-titer O-group whole blood (Drug)

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)".

干预措施: ABO- and Rh-compatible whole blood (Drug)

结局指标

主要结局

survival rate

时间窗: 24 hours,30 days

次要结局

未报告次要终点

研究者

发起方
Xijing Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

yin wen

chief physician

Xijing Hospital

研究点 (1)

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