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

Primary Purpose

Burns

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Viscoelastic (VE) Guided Transfusion
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • Parkland Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Viscoelastic (VE) guided transfusion

Standard practice transfusion

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 23, 2016
Last Updated
April 21, 2021
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03730415
Brief Title
The Effects of Viscoelastometry Guided Resuscitation During Burn Excision on Post Resuscitation Infections
Official Title
The Effects of Viscoelastic Guided Transfusions During Severe Thermal Injury Burn Excision on Post Transfusion Infections
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
August 12, 2019 (Actual)
Study Completion Date
August 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Viscoelastic (VE) guided transfusion
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard practice transfusion
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Viscoelastic (VE) Guided Transfusion
Intervention Description
A viscoelastic analyzer (ROTEM) will be used to guide the transfusion algorithm during the burn wound excision of subjects enrolled into this arm
Primary Outcome Measure Information:
Title
Number of blood products transfused
Description
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
24 hours post randomization
Secondary Outcome Measure Information:
Title
Coagulation factors
Description
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
Title
Inflammatory Mediators - plasminogen activator inhibitor 1
Description
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
excision to 24 hours post excision
Other Pre-specified Outcome Measures:
Title
Post transfusion infections
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael W Cripps, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75206
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22719014
Citation
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.
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The Effects of Viscoelastometry Guided Resuscitation During Burn Excision on Post Resuscitation Infections

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