Transfusion Ratio of Fresh Frozen Plasma (FFP) to Packed Red Blood Cell (PRBC) During Burn Excision and Grafting

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Burn Injury

Intervention / Treatment
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* Other: Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) 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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1:1 Ratio of FFP to PRBC<br>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) | Other: Treatment<br>* 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)<br>|
| Active Comparator: 1:4 Ratio FFP to PRBC<br>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) | Other: Treatment<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline to 12 months- From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in rate of survival | survival outcome as captured at discharge | 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 | from operation start to 12 hours post operatively | 
| change in hospital length of stay | Number of days in hospital from admit to discharge | 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 | 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 | 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 | From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FFP, PRBC, Burn