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

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

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

Study Overview

• Status: Completed
• Conditions: Burn Injury
• Intervention / Treatment: Other: Treatment

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Shriners Hospital for Children Northern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	Other: Treatment; 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)
Active Comparator: 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)	Other: Treatment; 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shriners Hospitals for Children
• Investigators: Principal Investigator: Tina Palmieri, MD, SHCNC and UC Davis

Publications and helpful links

General Publications

• Palmieri TL, Sen S, Falwell K, Greenhalgh DG. Blood product transfusion: does location make a difference? J Burn Care Res. 2011 Jan-Feb;32(1):61-5. doi: 10.1097/BCR.0b013e318204b3ea.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2010
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: August 31, 2012
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: FFP; PRBC; Burn
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: SHC 70014; 216586 (Other Identifier: UC Davis IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No