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

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ClinicalTrials.gov Identifier: NCT03730415
Recruitment Status : Completed
First Posted : November 5, 2018
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
Michael Cripps, University of Texas Southwestern Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Burns Procedure: Viscoelastic (VE) Guided Transfusion Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Viscoelastic Guided Transfusions During Severe Thermal Injury Burn Excision on Post Transfusion Infections
Actual Study Start Date : May 2016
Actual Primary Completion Date : August 12, 2019
Actual Study Completion Date : August 12, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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
No Intervention: Standard practice transfusion
The standard practice transfusion group will receive the current standard transfusion practice during their burn excision, which is based solely on physician preference using standard lab values.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730415


Locations
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United States, Texas
Parkland Memorial Hospital
Dallas, Texas, United States, 75206
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Michael W Cripps, MD UT Southwestern Medical Center
More Information
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Publications:

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Responsible Party: Michael Cripps, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03730415    
Other Study ID Numbers: 032014-072
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Burns
Wounds and Injuries