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

NCT05063409 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-10-01

No results posted yet for this study

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

Conditions

  • Burn Injury

Interventions

OTHER

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)

Sponsors & Collaborators

  • Shriners Hospitals for Children

    lead OTHER

Principal Investigators

  • Tina Palmieri, MD · SHCNC and UC Davis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2019-12-31
Completion
2020-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05063409 on ClinicalTrials.gov