Transfusion Ratio of Fresh Frozen Plasma (FFP) to Packed Red Blood Cell (PRBC) During Burn Excision and Grafting (FFP)
Primary Purpose
Burn Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Burn Injury focused on measuring FFP, PRBC, Burn
Eligibility Criteria
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
Sites / Locations
- Shriners Hospital for Children Northern California
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1:1 Ratio of FFP to PRBC
1:4 Ratio FFP to PRBC
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
change in rate of survival
survival outcome as captured at discharge
change in coagulopathy in the operative period as defined by change in PT/PTT measurement
PT/PTT obtained pre and post operatively per protocol
change in hospital length of stay
Number of days in hospital from admit to discharge
change in number of infectious episodes
number of new onset infections captured as defined by the Burn Sepsis Consensus Conference
change in organ dysfunction
Change in organ dysfunction as evidenced by change in MODS
change in pulmonary dysfunction
pulmonary dysfunction measured by P:F ratio and number of days on mechanical ventilation
Full Information
NCT ID
NCT05063409
First Posted
August 31, 2012
Last Updated
September 21, 2021
Sponsor
Shriners Hospitals for Children
1. Study Identification
Unique Protocol Identification Number
NCT05063409
Brief Title
Transfusion Ratio of Fresh Frozen Plasma (FFP) to Packed Red Blood Cell (PRBC) During Burn Excision and Grafting
Acronym
FFP
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 2010 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
February 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shriners Hospitals for Children
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Injury
Keywords
FFP, PRBC, Burn
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1:1 Ratio of FFP to PRBC
Arm Type
Active Comparator
Arm Description
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)
Arm Title
1:4 Ratio FFP to PRBC
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Treatment
Intervention Description
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)
Primary Outcome Measure Information:
Title
change in the amount of blood transfused in the operating room and during hospitalization
Description
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
Secondary Outcome Measure Information:
Title
change in rate of survival
Description
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
Title
change in coagulopathy in the operative period as defined by change in PT/PTT measurement
Description
PT/PTT obtained pre and post operatively per protocol
Time Frame
from operation start to 12 hours post operatively
Title
change in hospital length of stay
Description
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
Title
change in number of infectious episodes
Description
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
Title
change in organ dysfunction
Description
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
Title
change in pulmonary dysfunction
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tina Palmieri, MD
Organizational Affiliation
SHCNC and UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shriners Hospital for Children Northern California
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21107270
Citation
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.
Results Reference
background
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Transfusion Ratio of Fresh Frozen Plasma (FFP) to Packed Red Blood Cell (PRBC) During Burn Excision and Grafting
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