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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05063409
Other study ID # SHC 70014
Secondary ID 216586
Status Completed
Phase N/A
First received
Last updated
Start date September 2010
Est. completion date February 28, 2020

Study information

Verified date September 2021
Source Shriners Hospitals for Children
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
United States Shriners Hospital for Children Northern California Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

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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