The Effects of Viscoelastometry Guided Resuscitation During Burn Excision on Post Resuscitation Infections

Burns Clinical Trial

Official title:

The Effects of Viscoelastic Guided Transfusions During Severe Thermal Injury Burn Excision on Post Transfusion Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03730415
• Other study ID #: 032014-072
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: August 12, 2019

Study information

• Verified date: April 2021
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 12, 2019
• Est. primary completion date: August 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Burn patients admitted to Parkland Hospital with total burn surface area (TBSA) greater than 20%

Exclusion Criteria:

• Patients admitted to Parkland Hospital for reasons other than burns or for burns less than or equal to 20%

Related Conditions & MeSH terms

• Burns

Intervention

Procedure:
• Viscoelastic (VE) Guided Transfusion
A viscoelastic analyzer (ROTEM) will be used to guide the transfusion algorithm during the burn wound excision of subjects enrolled into this arm

Locations

Country	Name	City	State
United States	Parkland Memorial Hospital	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Schaden E, Kimberger O, Kraincuk P, Baron DM, Metnitz PG, Kozek-Langenecker S. Perioperative treatment algorithm for bleeding burn patients reduces allogeneic blood product requirements. Br J Anaesth. 2012 Sep;109(3):376-81. doi: 10.1093/bja/aes186. Epub 2012 Jun 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post transfusion infections	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.	30 days
Primary	Number of blood products transfused	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.	24 hours post randomization
Secondary	Coagulation factors	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.	excision to 24 hours post excision
Secondary	Inflammatory Mediators - plasminogen activator inhibitor 1	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.	excision to 24 hours post excision