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

The University of Texas System (UT)

Status: Completed

Conditions: Burns

Treatments: Procedure: Viscoelastic (VE) Guided Transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03730415

032014-072

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Viscoelastic (VE) guided transfusion

Experimental group

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.

Treatment:

Procedure: Viscoelastic (VE) Guided Transfusion

Standard practice transfusion

No Intervention group

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.