A Randomized Control Trial for evaluation of effects of leukoreduced blood transfusion on infection risk in severely injured trauma patient
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AIIMS
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Primary outcome will include development of all hospital acquired infections [urinary tract infections (UTI), bloodstream infections (BSI), pneumonia (PNEU), ventilator-associated infections (VAE), and surgical site infections (SSI)] as defined by CDC/NHSN surveillance definition
研究概览
简要总结
Blood transfusion plays an important role in the management of trauma patients. Transfusion of blood components leads to introduction of immune components such as white blood cells, antibodies and cytokines responsible for Immune alterations in the recipients. In severely injured patients a dysregulated immune response due to the trauma itself along with large requirement of blood transfusion over shorter time periods making them more susceptible to the immunomodulatory effects of blood transfusion. Often resulting in complications like increased risk of infections, length of stay, pulmonary morbidity, postinjury MOF (multiple organ failure) and mortality in these group of patient. Leukoreduction of the blood components before transfusion has been advocated to decrease the effect of immunomodulation by eliminating direct actions of the leukocytes as well as the accumulation of leukocyte-derived inflammatory mediators.
In this study we will compare the incidence of hospital acquired infections in severely injured trauma patients transfused with leukoreduced (LR) vs non-leukoreduced (NLR) blood components. We will also measure outcomes clinically and quantitative changes in biomarkers/microbiological indicators bacterial infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •all patients above 18 years of age receiving RBC transfusion within 24 hours of admission.
排除标准
- •Patients with an anticipated survival of less than 48 hours 2)Isolated head injury patients 3)Received blood transfusion elsewhere 4)Presence of active infection 5)Pregnant females and jail inmates will be not eligible for randomization.
- •Patient with Rh(D) negative groups.
结局指标
主要结局
Primary outcome will include development of all hospital acquired infections [urinary tract infections (UTI), bloodstream infections (BSI), pneumonia (PNEU), ventilator-associated infections (VAE), and surgical site infections (SSI)] as defined by CDC/NHSN surveillance definition
时间窗: Till the time of discharge or hospital death whichever is earlier
次要结局
- Monitoring of the quantitative levels of sTREM and procalcitonin measured in all patients.(Proportion of patient showing values above cut-off limit shall be considered as having infection)