The Incidence of Transfusion-Related Acute Lung Injury (TRALI) Following Blood Product Transfusion in Patients Undergoing Elective Orthopedic-Oncology Procedures
试验速览
- 阶段
- 不适用
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- The incidence of TRALI in patients undergoing orthopedic-oncology procedures, following blood product transfusion
研究概览
简要总结
Currently Transfusion-related acute lung injury (TRALI) is the leading cause of transfusion-related mortality in the United States, and one of major post-transfusion complications. TRALI is defined as new ALI occurring within 6 hours from the onset of transfusion. It is manifested by acute dyspnea, hypoxemia and bilateral infiltrates in chest radiograph. TRALI may be caused by any blood product and is not dose-dependent. Associated risk factors include prolonged storage of blood products and underlying conditions such as severe IHD hematologic malignancies or active infections. Since TRALI has only recently been defined as a clinical entity, and its prevalence has been largely underestimated - the epidemiology of TRALI is not well established. Therefore the objective of this work is to study the incidence of TRALI in a patient population that receive blood products frequently, namely orthopedic-oncologic.
详细描述
Background
The transfusion of blood products is occasionally complicated by acute lung injury (ALI), which can progress to the acute respiratory distress syndrome (ARDS). Such transfusion-related acute lung injury, abbreviated TRALI, has been defined by both a National Heart, Lung, and Blood Institute (NHLBI) working group, and by a Canadian consensus conference (CCC), as new ALI occurring during or within six hours after a transfusion [1-2]. This definition is based entirely on clinical and radiological criteria and includes [2-4]:
- ALI, as defined by [4]:
A. The sudden onset of respiratory distress symptoms (dyspnea). B. Hypoxemia: as defined by a ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FiO2) below 300mmHg, or oxygen saturation (SpO2) below 90% on room air, or other clinical evidence of hypoxemia C. Bilateral infiltrates on frontal chest X-ray, without cardiomegaly. D. No clinical evidence of left atrial hypertension (congestive heart disease). 2. No preexisting ALI before transfusion. 3. During or within 6 hr after transfusion of any blood product. 4. No temporal relationship to an alternative risk factor for ALI. All types of blood products have been associated with TRALI, however, the plasma-rich components, such as fresh frozen plasma (FFP), whole blood, packed red blood cells (PC) and platelets, have been most frequently implicated [3, 5-10].
Prolonged storage of transfused products, use of FFP, and the presence of an underlying condition such as recent surgery, cytokine treatment, thrombocytopenia, massive blood transfusion, hematologic malignancies or cardiovascular disease requiring cardiopulmonary bypass (CABG) surgery, and active infection have been reported as risk factors for the development of TRALI [11-18].
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged >18 years old, with ASA I-III, undergoing elective orthopedic-oncology procedures in the Sourasky Medical Center, and receiving blood products pre-, intra-, or post-operatively.
排除标准
- •Patients with a history of chronic renal insufficiency (creatinine > 1.5 of normal value), congestive heart failure, hepatic dysfunction, preexisting ALI, or acute infection.
结局指标
主要结局
The incidence of TRALI in patients undergoing orthopedic-oncology procedures, following blood product transfusion
时间窗: 2 years
次要结局
- The correlation between the incidence of TRALI and the age of blood product(2 years)