Parkland Memorial Hospital
Dallas, Texas, 75206, United States
NCT Number: NCT03730415
This is a randomized controlled trial to compare viscoelastometric (VE) guided transfusion to standard practice transfusion in severe thermal injury burn excision on the utilization of blood products, effects on coagulation and inflammatory mediators, and how these strategies affect post resuscitation infections.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Dallas, Texas, 75206, United States
This is an open labeled study as the viscoelastometric (VE) guided transfusion will be based on the visible VE results. Subjects will be randomized to receive either the standard practice transfusion or VE guided transfusion. Blood samples, standard demographic information, and routine laboratory data will be collected on all subjects in the Burn ICU (BICU) enrolled in the study. VE analysis will be performed on ALL subjects immediately prior to the burn excision, and approximately every 40 minutes while the patient is in the operating room (OR) as well as on arrival to the BICU and every 8 hours depending on their need for ongoing transfusion for a maximum of 24 hours. As our intervention, only the VE based transfusion group will have access to the VE analysis at time of transfusion. The VE results will be used at the discretion of the treating physician based on the VE guided transfusion algorithm. Outcomes include the number and timing of blood products transfused from the time of randomization to 24 hours post randomization and the presence of any 30 day post-transfusion infections.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A viscoelastic analyzer (ROTEM) will be used to guide the transfusion algorithm during the burn wound excision of subjects enrolled into this arm
Time frame: 24 hours post randomization
Compare the number of blood products transfused in VE guided transfusion versus standard practice transfusion in burned patients (TBSA >20%) undergoing burn wound excision will be analyzed.
Time frame: excision to 24 hours post excision
Compare the effects of VE guided transfusion to standard practice transfusion on the coagulation factor in patients undergoing burn wound excision. Changes in individual coagulation factors will be measured. Will measure other related mediators including coagulation Factors V, VIII, and plasminogen activator inhibitor 1 (PAI-1) which have also been implicated in ATC.
Time frame: excision to 24 hours post excision
Compare the effects of VE guided transfusion to standard practice transfusion on the inflammatory mediators in patients undergoing burn wound excision. Changes in inflammatory mediators will be measured. Further, analysis into interactions between these factors will be studied.
Time frame: 30 days
Compare the post transfusion infections to the number of blood products transfused for VE guided transfusion and standard practice transfusion in patients undergoing burn wound excision.
University of Texas Southwestern Medical Center
Other
The Effects of Viscoelastic Guided Transfusions During Severe Thermal Injury Burn Excision on Post Transfusion Infections
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