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

Shriners Hospitals for Children

Status: Completed

Conditions: Burn Injury

Treatments: Other: Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05063409

SHC 70014

216586 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

1:1 Ratio of FFP to PRBC

Active Comparator group

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)

Treatment:

Other: Treatment

1:4 Ratio FFP to PRBC

Active Comparator group

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)

Treatment:

Other: Treatment