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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- change in the amount of blood transfused in the operating room and during hospitalization
Study Overview
Brief Summary
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
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Month to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •* Patient is 1 month to \/= 20 % total body surface area (TBSA)
Exclusion Criteria
- •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
Arms & Interventions
1:1 Ratio of FFP to PRBC
Randomized treatment to receive blood products at a ratio of 1:1 FFP to PRBC during the operative period (start of surgery to 12 hours post operatively)
Intervention: Treatment (Other)
1:4 Ratio FFP to PRBC
Randomized treatment to receive blood products at a ratio of 1:4 FFP to PRBC during the operative period (start of surgery to 12 hours post operatively)
Intervention: Treatment (Other)
Outcomes
Primary Outcomes
change in the amount of blood transfused in the operating room and during hospitalization
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
All transfusions during the operative period and entire hospitalization will be documented
Secondary Outcomes
- 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)
Investigators
Tina L Palmieri
Assistant Chief of Burns
Shriners Hospitals for Children