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

NCT ID: NCT05063409

Last Updated: 2021-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2020-02-28

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.

Conditions

Burn Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1:1 Ratio of FFP to PRBC

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)

Group Type: ACTIVE_COMPARATOR

Treatment

Intervention Type: OTHER

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)

1:4 Ratio FFP to PRBC

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)

Group Type: ACTIVE_COMPARATOR

Treatment

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shriners Hospitals for Children

OTHER

Sponsor Role: lead

Responsible Party

Tina L Palmieri

Assistant Chief of Burns

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tina Palmieri, MD

Role: PRINCIPAL_INVESTIGATOR

SHCNC and UC Davis

Locations

Shriners Hospital for Children Northern California

Sacramento, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21107270 (View on PubMed)

Other Identifiers

216586

Identifier Type: OTHER

Identifier Source: secondary_id

SHC 70014

Identifier Type: -

Identifier Source: org_study_id