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Completed

NCT Number: NCT05063409

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

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

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Key information

Conditions

Burn Injury Burns Wounds and Injuries

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shriners Hospital for Children Northern California

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. change in the amount of blood transfused in the operating room and during hospitalization

    Time frame: Baseline to 12 months- From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months

    All transfusions during the operative period and entire hospitalization will be documented

Secondary outcomes

  1. change in rate of survival

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

    survival outcome as captured at discharge

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

    Time frame: from operation start to 12 hours post operatively

    PT/PTT obtained pre and post operatively per protocol

  3. change in hospital length of stay

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

    Number of days in hospital from admit to discharge

  4. change in number of infectious episodes

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

    number of new onset infections captured as defined by the Burn Sepsis Consensus Conference

  5. change in organ dysfunction

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

    Change in organ dysfunction as evidenced by change in MODS

  6. change in pulmonary dysfunction

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

    pulmonary dysfunction measured by P:F ratio and number of days on mechanical ventilation

Sponsors and collaborators

Lead sponsor

Shriners Hospitals for Children

Other

Registry information

Official study 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

Acronym: FFP

Important dates

Study start
2010
Primary completion
2019
Study completion
2020
First posted
Oct 1, 2021
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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