BurnsLBONCT00731887
Large Burn Outcome Study
An observational study of Burns, run by The University of Texas Medical Branch, Galveston.
Trial summary
To examine long term physical and psychosocial outcomes of pediatric burn survivors. We want to learn about thoughts, feelings, coping style, social support, and overall adjustment following burn injury. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Blood and urine testing
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Those that have received a burn injury at least 3 years ago and that recieved acute burn treatment at Shriners Hospital for Children - Galveston between 1986-2005.
Who may be able to join
- At least 60% third degree total body surface area
- Acute burn treatment at Shriners Burns Hospital for Children - Galveston between 1986-2005
- Three years post injury
- Current age of at least 16 years
Who cannot join
None listed.
About this study
Official title: Assessment of the Treatment of the Severely Burned With Anabolic Agents on Improved Wound Healing, Recovery and Rehabilitation: Large Burn Outcome Study
To examine long term physical and psychosocial outcomes of pediatric burn survivors. We want to learn about thoughts, feelings, coping style, social support, and overall adjustment following burn injury.
Read the detailed description
To evaluate the long term quality of life of adolescents and adults who suffered severe pediatric burns. This study will include an array of physical and psychosocial assessments, thus providing a unique and complete set of information on the long term outcomes in this population.
- Conditions
- Burns
- Being tested
- Blood and urine testing
- Keywords
- Burn injury, Burn recovery
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and urine testingProcedure or surgery
complete blood count, routine chemistries, liver function test, retinol binding protein, transferrin, prothrombin time, partial thromboplastin time, fibrinogen, Vitamin A and Zinc, Insulin Growth Factor levels and binding proteins, cytokines (interleukins 1, 6, 12), insulin, thyroid hormones, cortisol, 25-hydroxyvitamin D, and osteocalcin.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startJun 2011
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Personnel involved in this protocol are no longer associated with this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education, Shriners Hospitals for Children
- Responsible party
- Sponsor
- Investigators
- David N Herndon, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731887
- Sponsor's protocol ID
- 04-157B
- Acronym
- LBO
- Status last verified
- Dec 2013
- First submitted
- 30 Jul 2008
- Last updated
- 8 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Treatment of the Severely Burned With Anabolic Agents on Improved Wound Healing, Recovery and Rehabilitation: Large Burn Outcome Study
- ClinicalTrials.gov ID
- NCT00731887
- Acronym / sponsor ID
- LBO / 04-157B
- Conditions
- Burns
- Keywords
- Burn injury, Burn recovery
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Personnel involved in this protocol are no longer associated with this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- U.S. Department of Education, Shriners Hospitals for Children
- Study start
- Jun 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine long term physical and psychosocial outcomes of pediatric burn survivors. We want to learn about thoughts, feelings, coping style, social support, and overall adjustment following burn injury.
Detailed description
To evaluate the long term quality of life of adolescents and adults who suffered severe pediatric burns. This study will include an array of physical and psychosocial assessments, thus providing a unique and complete set of information on the long term outcomes in this population.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Those that have received a burn injury at least 3 years ago and that recieved acute burn treatment at Shriners Hospital for Children - Galveston between 1986-2005.
Key inclusion criteria (4 listed)
- At least 60% third degree total body surface area
- Acute burn treatment at Shriners Burns Hospital for Children - Galveston between 1986-2005
- Three years post injury
- Current age of at least 16 years
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and urine testingcomplete blood count, routine chemistries, liver function test, retinol binding protein, transferrin, prothrombin time, partial thromboplastin time, fibrinogen, Vitamin A and Zinc, Insulin Growth Factor levels and binding proteins, cytokines (interleukins 1, 6, 12), insulin, thyroid hormones, cortisol, 25-hydroxyvitamin D, and osteocalcin. | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2014.
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Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David N Herndon, MD principal investigator
University of Texas
Questions about this trial
What is this clinical trial studying?
An observational study of Burns, run by The University of Texas Medical Branch, Galveston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2014.