Understanding Coagulation and Inflammation in Burns

NCT03077269 | Terminated DMC

• 1 other identifier: STUDY00060710
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand what happens to platelets and blood clotting factors in burn patients over time. This study will also examine the role of microparticles (MPs), nanoparticles (NPs), and micro RNA in burns. The investigators will be looking at small particles of cells that are released into the blood. These particles have been found to be important in a variety of different diseases. The investigators believe that MPs, NPs, and micro RNA may play a role in development of inflammation, and infections in burn patients. Thus, hopefully, this study will help understand how to minimize transfusions and bleeding in burn patients as well as how to reduce inflammation and infections in burn patients.

Conditions

Burns

Keywords

burn; coagulation; inflammation

Outcome Measures

Primary Outcomes (2)

• measurement of coagulation factor levels over time

  coagulation factor levels will be measured using laboratory testing

  during hospital admission for up to 30 days

• development of sepsis and infections

  sepsis and infection will be monitored using CRP values by lab testing as well as blood and urine cultures

  during hospital admission for up to 30 days

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients presenting with 2nd or 3rd degree burns older than age 18

You may qualify if:

• Adults \>18 years of age with 2nd and/or 3rd degree burns and any degree of associated trauma
• Elderly

You may not qualify if:

• Children \<18 years of age
• Prisoners
• Pregnant females

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma and microparticles

MeSH Terms

Conditions

Burns; Thrombosis; Inflammation

Condition Hierarchy (Ancestors)

Wounds and Injuries; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 10, 2017
• Study Start: May 1, 2016
• Primary Completion: May 19, 2025
• Study Completion: May 19, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)