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

Burn Injury Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05063409
• Other study ID #: SHC 70014
• Secondary ID: 216586
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Est. completion date: February 28, 2020

Study information

• Verified date: September 2021
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 28, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn Injury
• Burns

Intervention

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)

Locations

Country	Name	City	State
United States	Shriners Hospital for Children Northern California	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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