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Completed

NCT Number: NCT03730415

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parkland Memorial Hospital

Dallas, Texas, 75206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Viscoelastic (VE) Guided Transfusion

Procedure

A viscoelastic analyzer (ROTEM) will be used to guide the transfusion algorithm during the burn wound excision of subjects enrolled into this arm

Primary outcomes

  1. Number of blood products transfused

    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.

Secondary outcomes

  1. Coagulation factors

    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.

  2. Inflammatory Mediators - plasminogen activator inhibitor 1

    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.

Other outcomes

  1. Post transfusion infections

    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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 5, 2018
Registry last updated
Apr 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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