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

NCT03730415 | Completed DMC

• 1 other identifier: 032014-072
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours post randomization

Secondary Outcomes (2)

• Coagulation factors

  excision to 24 hours post excision

• Inflammatory Mediators - plasminogen activator inhibitor 1

  excision to 24 hours post excision

Other Outcomes (1)

• Post transfusion infections

  30 days

Study Arms (2)

Viscoelastic (VE) guided transfusion

EXPERIMENTAL

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

Standard practice transfusion

NO INTERVENTION

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.

Interventions

Viscoelastic (VE) Guided Transfusion PROCEDURE

A viscoelastic analyzer (ROTEM) will be used to guide the transfusion algorithm during the burn wound excision of subjects enrolled into this arm

Viscoelastic (VE) guided transfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Burn patients admitted to Parkland Hospital with total burn surface area (TBSA) greater than 20%

You may not qualify if:

• Patients admitted to Parkland Hospital for reasons other than burns or for burns less than or equal to 20%

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Memorial Hospital

Dallas, Texas, 75206, United States

Location

Related Publications (1)

• 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.

  PMID: 22719014 BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Michael W Cripps, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: November 5, 2018
• Study Start: May 1, 2016
• Primary Completion: August 12, 2019
• Study Completion: August 12, 2019
• Last Updated: April 23, 2021

Record last verified: 2021-04

Locations

US (1)