Burn Injury Clinical Trial
— FFPOfficial 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
Verified date | September 2021 |
Source | Shriners Hospitals for Children |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 72 |
Est. completion date | February 28, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Shriners Hospital for Children Northern California | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
Shriners Hospitals for Children |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | change in rate of survival | survival outcome as captured at discharge | From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months | |
Secondary | change in coagulopathy in the operative period as defined by change in PT/PTT measurement | PT/PTT obtained pre and post operatively per protocol | from operation start to 12 hours post operatively | |
Secondary | change in hospital length of stay | Number of days in hospital from admit to discharge | From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months | |
Secondary | change in number of infectious episodes | number of new onset infections captured as defined by the Burn Sepsis Consensus Conference | From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months | |
Secondary | change in organ dysfunction | Change in organ dysfunction as evidenced by change in MODS | From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months | |
Secondary | change in pulmonary dysfunction | pulmonary dysfunction measured by P:F ratio and number of days on mechanical ventilation | From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months |
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