WithdrawnNot Applicable

Liver, Pancreas and Thyroid Function in Burn Patients

Stopped: The study PI has left the institution.

United States0Started 2018-06-25

Plain-language summary

The purpose of this study is to determine the extent to which severe burn injuries affect the morphology and function of liver, pancreas and thyroid. The evaluation of the liver will be performed non-invasively with liver fibrosis scores based on standard blood parameters and the measurement of liver stiffness (correlated with liver fibrosis) and controlled attenuation parameter (CAP, correlated with hepatic steatosis) via transient elastography (FibroScan©, Echosens SA, Paris, France). The thyroid and the pancreas will be assessed via ultrasound (GE Medical Systems, Waukesha, USA) and standard blood parameters, respectively.

Who can participate

Age range

6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Patients with partial thickness burns. Only patients who sign an IRB-approved consent (≥18 years old) or assent and have their legal guardian consenting to their participation (6 months - 17 years old) will be included. * Patient age \> 6 months * Total body surface area (TBSA) burned ≥ 30 % * Flame, electrical, scald or chemical injury, contact burn * Toxic epidermal necrolysis (TENS) Exclusion Criteria: * Patient \< 6 months * TBSA burned \< 30 %

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Liver stiffness (kPa)

Timeframe: 24 months

Controlled Attenuation Parameter

Timeframe: 24 months

Liver diameter (cm)

Timeframe: 24 months

Platelet count (/nl)

Timeframe: 24 months

High-density lipoprotein (mg/dl)

Timeframe: 24 months

Low-density lipoprotein (mg/dl)

Timeframe: 24 months

Triglycerides (mg/dl)

Timeframe: 24 months

Cholesterol (mg/dl)

Timeframe: 24 months

Trial details

NCT IDNCT03598283

SponsorThe University of Texas Medical Branch, Galveston

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-06-30

View on ClinicalTrials.gov More Burns trials

Plain-language summary

Who can participate

Age range

6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Liver stiffness (kPa)

Timeframe: 24 months

Controlled Attenuation Parameter

Timeframe: 24 months

Liver diameter (cm)

Timeframe: 24 months

Platelet count (/nl)

Timeframe: 24 months

High-density lipoprotein (mg/dl)

Timeframe: 24 months

Low-density lipoprotein (mg/dl)

Timeframe: 24 months

Triglycerides (mg/dl)

Timeframe: 24 months

Cholesterol (mg/dl)

Timeframe: 24 months