Clinical trial NCT05063409: Transfusion Ratio of Fresh Frozen Plasma (FFP) to Packed Red Blood Cell (PRBC) During Burn Excision and Grafting
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
Overall status: COMPLETED
Phase: NA
Conditions: Burn Injury
Keywords: FFP
PRBC
Burn
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 72
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change in the amount of blood transfused in the operating room and during hospitalization
timeFrame: Baseline to 12 months- From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
Secondary outcomes:
measure: change in rate of survival
timeFrame: From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
measure: change in coagulopathy in the operative period as defined by change in PT/PTT measurement
timeFrame: from operation start to 12 hours post operatively
measure: change in hospital length of stay
timeFrame: From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
measure: change in number of infectious episodes
timeFrame: From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
measure: change in organ dysfunction
timeFrame: From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
measure: change in pulmonary dysfunction
timeFrame: From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Shriners Hospital for Children Northern California
state: California
Study officials:
affiliation: SHCNC and UC Davis
name: Tina Palmieri, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.