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

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03730415
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 39.4
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Burns	Procedure: Viscoelastic (VE) Guided Transfusion	N/A

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

• Study Type: Interventional
• 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 1, 2016
• Actual Primary Completion Date: Aug 12, 2019
• Actual Study Completion Date: Aug 12, 2019

Arms and Interventions

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

Primary Outcome Measures

1. 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

1. 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.

2. 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.

Other Outcome Measures

1. Post transfusion infections [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Parkland Memorial Hospital	Dallas	Texas	United States	75206

Sponsors and Collaborators

• University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: Michael W Cripps, MD, UT Southwestern Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Michael Cripps, Assistant Professor, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT03730415
• Other Study ID Numbers: 032014-072
• First Posted: Nov 5, 2018
• Last Update Posted: Apr 23, 2021
• Last Verified: Apr 1, 2021

• Additional relevant MeSH terms: Burns

Study Results

No Results Posted as of Apr 23, 2021