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

NCT ID: NCT03730415

Last Updated: 2021-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-08-12

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.

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Viscoelastic (VE) Guided Transfusion

Intervention Type: PROCEDURE

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: PROCEDURE

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%

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Cripps

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael W Cripps, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

Parkland Memorial Hospital

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22719014 (View on PubMed)

Other Identifiers

032014-072

Identifier Type: -

Identifier Source: org_study_id