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

NCT05063409 | Completed

• 2 other identifiers: SHC 70014216586
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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. 1.decrease in the amount of blood transfused in the operating room
2. 2.decrease in the amount of blood transfused during hospitalization
3. 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. 4.decrease the hospital length of stay, lung dysfunction, infections, and mortality

Conditions

Burn Injury

Keywords

FFP; PRBC; Burn

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• change in rate of survival

  From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months

• change in coagulopathy in the operative period as defined by change in PT/PTT measurement

  from operation start to 12 hours post operatively

• change in hospital length of stay

  From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months

• change in number of infectious episodes

  From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months

• change in organ dysfunction

  From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months

Study Arms (2)

1:1 Ratio of FFP to PRBC

ACTIVE COMPARATOR

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)

Other: Treatment

1:4 Ratio FFP to PRBC

ACTIVE COMPARATOR

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)

Other: Treatment

Interventions

Treatment 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)

1:1 Ratio of FFP to PRBC; 1:4 Ratio FFP to PRBC

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Infants \< 5 kg
• Pregnancy
• 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

Sponsors & Collaborators

• Shriners Hospitals for Children: lead

Study Sites (1)

Shriners Hospital for Children Northern California

Sacramento, California, 95817, United States

Location

Related 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.

  PMID: 21107270 BACKGROUND

MeSH Terms

Conditions

Burns

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Tina Palmieri, MD

  SHCNC and UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Chief of Burns

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: October 1, 2021
• Study Start: September 1, 2010
• Primary Completion: December 31, 2019
• Study Completion: February 28, 2020
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)