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

Not Applicable

Completed

• Conditions: Burns
• Interventions: Procedure: Viscoelastic (VE) Guided Transfusion

• Registration Number: NCT03730415
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2018-11-01
• Study First Posted: 2018-11-05
• Primary Completion: 2019-08-12
• Study Completion: 2019-08-12
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Viscoelastic (VE) guided transfusion	Viscoelastic (VE) Guided Transfusion	The intervention made in the VE guided transfusion group is that the VE results will be available to the treating physicians to guide transfusions based on VE results during their burn excision.

Primary Outcome Measures

Name	Time	Method
Number of blood products transfused	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.

Secondary Outcome Measures

Name	Time	Method
Coagulation factors	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.
Inflammatory Mediators - plasminogen activator inhibitor 1	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.

Trial Locations

Locations (1)

Parkland Memorial Hospital; 🇺🇸 Dallas, Texas, United States