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Understanding Coagulation and Inflammation in Burns

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ClinicalTrials.gov Identifier: NCT03077269
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Derek Bell, University of Rochester

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.

Condition or disease
Burns

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Understanding Coagulation and Inflammation in Burns
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns




Primary Outcome Measures :
  1. measurement of coagulation factor levels over time [ Time Frame: during hospital admission for up to 30 days ]
    coagulation factor levels will be measured using laboratory testing

  2. development of sepsis and infections [ Time Frame: during hospital admission for up to 30 days ]
    sepsis and infection will be monitored using CRP values by lab testing as well as blood and urine cultures


Biospecimen Retention:   Samples Without DNA
plasma and microparticles


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients presenting with 2nd or 3rd degree burns older than age 18
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077269


Contacts
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Contact: Derek E Bell, MD 585-275-1000 Derek_Bell@urmc.rochester.edu
Contact: Colleen Fodge, RN, MHA 585-276-6551 Colleen_Fodge@urmc.rochester.edu

Locations
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United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Derek E Bell    585-275-1000      
Sponsors and Collaborators
University of Rochester

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Responsible Party: Derek Bell, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT03077269     History of Changes
Other Study ID Numbers: RSRB00060710
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Derek Bell, University of Rochester:
burn
coagulation
inflammation
Additional relevant MeSH terms:
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Inflammation
Burns
Pathologic Processes
Wounds and Injuries