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

Not Applicable

Completed

• Conditions: Burn Injury
• Interventions: Other: Treatment

• Registration Number: NCT05063409
• Lead Sponsor: Shriners Hospitals for Children

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)

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

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2012-08-31
• Primary Completion: 2019-12-31
• Study Completion: 2020-02-28
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-21
• Last Update Submitted: 2021-09-21
• Study First Posted: 2021-10-01
• Last Update Posted: 2021-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1:1 Ratio of FFP to PRBC	Treatment	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)
1:4 Ratio FFP to PRBC	Treatment	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)

Primary Outcome Measures

Name	Time	Method
change in the amount of blood transfused in the operating room and during hospitalization	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 Outcome Measures

Name	Time	Method
change in pulmonary dysfunction	From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months	pulmonary dysfunction measured by P:F ratio and number of days on mechanical ventilation
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	number of new onset infections captured as defined by the Burn Sepsis Consensus Conference
change in coagulopathy in the operative period as defined by change in PT/PTT measurement	from operation start to 12 hours post operatively	PT/PTT obtained pre and post operatively per protocol
change in rate of survival	From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months	survival outcome as captured at discharge
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	Number of days in hospital from admit to discharge
change in organ dysfunction	From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months	Change in organ dysfunction as evidenced by change in MODS

Trial Locations

Locations (1)

Shriners Hospital for Children Northern California; 🇺🇸 Sacramento, California, United States