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| ID | Type | Description | Link |
|---|---|---|---|
| 216586 | Other Identifier | UC Davis IRB |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| change in coagulopathy in the operative period as defined by change in PT/PTT measurement |
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Inclusion Criteria:
Exclusion Criteria:
Infants < 5 kg
Pregnancy
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
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| Name | Affiliation | Role |
|---|---|---|
| Tina Palmieri, MD | SHCNC and UC Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shriners Hospital for Children Northern California | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21107270 | Background | 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. |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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PT/PTT obtained pre and post operatively per protocol |
| from operation start to 12 hours post operatively |
| 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 |
| 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 |
| 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 |
| 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 |