Is Long-Term Blood Storage Related With Increased Mortality and Adverse Effects in Severely Injured Trauma Patients?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- 28-day Mortality
研究概览
简要总结
The purpose of this retrospective study is to examine the following factors related to blood storage time in severely injured trauma patients who received large blood transfusions:
- The effect of blood storage time on the patient's 28-day mortality rate.
- The relationship between storage time and other health problems that the patient may develop (such as heart disease, vascular occlusion, respiratory failure, infection, and organ failure).
For this purpose, patients aged 18-75 who were admitted directly from the scene of injury and received large transfusions at Jacksonville Shands Hospital between January 1, 2023, and October 1, 2025, will be included. Data will be obtained from hospital information systems and anesthesia records
详细描述
Is Long-Term Blood Storage related with increased mortality and adverse effects in severely injured trauma patients?
Abstract
Background: Severe trauma remains a significant cause of mortality, often necessitating massive transfusion. During storage, red blood cells (RBCs) and whole blood units develop "storage lesions," encompassing biochemical and structural deteriorations such as oxidative damage to hemoglobin, metabolic derangements (e.g., lactate accumulation, adenosine triphosphate (ATP) and 2,3-diphosphoglycerate (2,3-DPG) depletion), and increased vesiculation. These changes are hypothesized to contribute to adverse clinical outcomes, including impaired microvascular perfusion, endothelial injury, hypercoagulability, inflammation, multi-organ dysfunction, and increased mortality. While numerous observational studies and meta-analyses suggest an association between prolonged blood storage duration and worse outcomes, large randomized controlled trials (RCTs) have yielded conflicting results. The impact of storage age on high-risk trauma patients requiring massive transfusion remains particularly uncertain.
Objective: This study aims to evaluate the effect of RBC and whole blood storage duration on 28-day mortality in severely injured trauma patients (Injury Severity Score (ISS) >15) undergoing massive transfusion. A secondary objective is to assess the relationship between storage duration and morbidity, including complications such as cardiac ischemia, thromboembolic events, acute respiratory failure, nosocomial infection, and multiple organ failure.
Methods: A single-center retrospective cohort study will be conducted at the University of Florida Jacksonville Shands Hospital. The study will include patients aged 18-75, with an ISS >15, who presented directly from the injury scene and received massive transfusion (defined as >10 packed RBC (PRBC) units in the first 24 hours or ≥3 units in 1 hour) between January 1, 2023, and October 1, 2025. Data will be extracted from hospital information systems and anesthesia records. The storage duration for each transfused unit (from collection to transfusion) will be recorded. Blood products are preserved with Adsol AS-1 additive solution, allowing storage of packed RBCs for 42 days and whole blood for 21 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18-75 years of age,
- •Injury Severity Score>15 and have received massive blood transfusions in our hospital from 1 January 2015 to 31 December 2025
- •The patients admitted because of trauma and undergoing surgery
排除标准
- •Patients with known cardiac or vascular diseases such as heart failure or malignant hypertension, those under anticoagulant treatment
- •Patients with known serious kidney (on dialysis), lung, liver diseases, those under anticoagulant treatment
- •Super obese patients with body mass index (BMI) 50 or above
研究组 & 干预措施
Group 1
The study will include patients aged 18-75, with an ISS >15, who presented directly from the injury scene and received massive transfusion (defined as >10 packed RBC (PRBC) units in the first 24 hours or ≥3 units in 1 hour) between January 1, 2023, and October 1, 2025. Data will be extracted from hospital information systems and anesthesia records. The storage duration for each transfused unit (from collection to transfusion) will be recorded.
结局指标
主要结局
28-day Mortality
时间窗: At the day of 28 after massive blood transfusion
The aim of this study was to evaluate the effect of red blood cell and whole blood storage duration on 28-day mortality in severely injured trauma patients (injury severity score \>15) undergoing massive transfusion.
次要结局
- 28-day Morbidity - Cardiac Ischemia(At the day of 28 after massive blood transfusion)
- 28-day morbidity- thromboembolic events(At the day of 28 after massive blood transfusion)
- 28-day morbidity- nosocomial infection(At the day of 28 after massive blood transfusion)
- 28-day morbidity- multiple organ failure(At the day of 28 after massive blood transfusion)
- 28-day morbidity- acute respiratory failure(At the day of 28 after massive blood transfusion)