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) 1. decrease in the amount of blood transfused in the operating room 2. decrease in the amount of blood transfused during hospitalization 3. 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 4. decrease the hospital length of stay, lung dysfunction, infections, and mortality
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Blood product transfusion at a ratio of 1:1 FFP to PRBC or 1:4 FFP to PRBC during the operative period (start of surgery to 12 hours post operatively)
Shriners Hospital for Children Northern California
Sacramento, California, United States
change in the amount of blood transfused in the operating room and during hospitalization
All transfusions during the operative period and entire hospitalization will be documented
Time frame: Baseline to 12 months- From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
change in rate of survival
survival outcome as captured at discharge
Time frame: 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
PT/PTT obtained pre and post operatively per protocol
Time frame: from operation start to 12 hours post operatively
change in hospital length of stay
Number of days in hospital from admit to discharge
Time frame: 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
number of new onset infections captured as defined by the Burn Sepsis Consensus Conference
Time frame: From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
change in organ dysfunction
Change in organ dysfunction as evidenced by change in MODS
Time frame: From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
change in pulmonary dysfunction
pulmonary dysfunction measured by P:F ratio and number of days on mechanical ventilation
Time frame: From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
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