A Randomized Prospective Trial of Fresh Frozen Plasma (FFP) to Packed Red Blood Cell (PRBC) Ratio: Comparison of a Traditional (1:4) to Liberal (1:1)FFP Transfusion Policy During Burn Excision and Grafting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- change in the amount of blood transfused in the operating room and during hospitalization
研究概览
简要总结
The purpose of this study is to determine if burn injured patients who receive blood transfusions in the operating room have better outcomes when given transfusions at a set ratio (1:1)of PRBC to FFP.
Traditionally, patients that need blood transfusions during surgery are given mostly packed red blood cells (PRBC) and some fresh frozen plasma (FFP). This is usually about 1:4 ratio of FFP to PRBC.
In this study, we will compare this traditional approach (1:4) to a 1:1 ratio of FFP to PRBC during the operative period.
The hypothesis of the study is that the use of FFP/PRBC ratio of 1:1, compared to a ratio of 1:4 will result in a(n)
- decrease in the amount of blood transfused in the operating room
- decrease in the amount of blood transfused during hospitalization
- improvement in coagulation parameters (PT/PTT, INR, antithrombin III, Protein C and Fibrinogen in the operative period (from operation start to 12 hours post operatively) and at 24 hours postoperatively
- decrease the hospital length of stay, lung dysfunction, infections, and mortality
详细描述
The hypothesis of the study is that the use of a fresh frozen plasma/packed red blood cells (FFP/PRBC) ratio of 1:1, compared to a ratio of 1:4 during operative excision of >20% TBSA will: result in a decrease in the amount of blood transfused in the operating room, a decrease in the amount of blood transfused during hospitalization, an improvement in coagulation parameters (PT/PTT, INR) in the operative period (from operation start to 12 hours postoperatively) and at 24 hours postoperatively, and a decrease in hospital length of stay, lung dysfunction, number of infections, and mortality.
The primary objective of the study is to determine if aggressive correction of intraoperative coagulopathy during burn excision and grafting results in improved outcomes.
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
- None
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 1 month to </= 18 yrs of age
- •Admitted to Shriners Hospitals for Children Northern California
- •Patient has a third degree burn >/= 20 % total body surface area (TBSA)
排除标准
- •Infants < 5 kg
- •Pregnancy
- •18 years of age
- •Inability or unwillingness to receive blood products
- •Pre-existing need for hemodialysis
- •Brain death or imminent brain death
- •Non-survivable burn as determined by the attending burn surgeon
- •Pre-existing hematologic disease
- •Closed head injury with Glasgow Coma Score <9
结局指标
主要结局
change in the amount of blood transfused in the operating room and during hospitalization
时间窗: Baseline to 12 months- From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
All transfusions during the operative period and entire hospitalization will be documented
次要结局
- change in pulmonary dysfunction(From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months)
- change in number of infectious episodes(From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months)
- change in coagulopathy in the operative period as defined by change in PT/PTT measurement(from operation start to 12 hours post operatively)
- change in rate of survival(From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months)
- change in hospital length of stay(From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months)
- change in organ dysfunction(From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months)
研究者
Tina L Palmieri
Assistant Chief of Burns
Shriners Hospitals for Children