Clinical Trials Directory

Trials / Completed

CompletedNCT03730415

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
University of Texas Southwestern Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREViscoelastic (VE) Guided TransfusionA viscoelastic analyzer (ROTEM) will be used to guide the transfusion algorithm during the burn wound excision of subjects enrolled into this arm

Timeline

Start date
2016-05-01
Primary completion
2019-08-12
Completion
2019-08-12
First posted
2018-11-05
Last updated
2021-04-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03730415. Inclusion in this directory is not an endorsement.

The Effects of Viscoelastometry Guided Resuscitation During Burn Excision on Post Resuscitation Infections (NCT03730415) · Clinical Trials Directory