Traumatic Brain InjuryNCT01666964
Hormone Deficiency After Brain Injury During Combat
An observational study of Traumatic Brain Injury and Hypopituitarism, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial summary
We would like to ascertain the prevalence of hypopituitarism after combat-related TBI. This will lead to enhanced awareness, recognition, and treatment of hypopituitarism, which can have life-saving ramifications and enhance quality of life and rehabilitation efforts in our combat veterans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Hypopituitarism
- What is being tested?
- Blast Traumatic Brain Injury
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to May 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female combat veterans age 18 years and older with the diagnosis of Traumatic Brain Injury that occurred 3 and 6 months prior to enrollment.
Who may be able to join
- Combat veterans who are 3 or 6 months post combat-related TBI and age 18yrs or older
- Must demonstrate capacity for informed consent
- Must be DEERS eligible (Military healthcare beneficiary)
Who cannot join
- Pregnancy (to be assessed by urine HCG)
- Use of hormonal contraceptives
- Chronic oral or intravenous glucocorticoids
- Use of hormonal therapy to include estrogen and testosterone
- Prior diagnosis of hypopituitarism prior to combat related TBI
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Andrew J Brackbill, M.D.
Kate H Kinnaird, M.D.
About this study
Official title: Prevalence of Hypopituitarism Following Combat-related Traumatic Brain Injury in a Military Population
We would like to ascertain the prevalence of hypopituitarism after combat-related TBI. This will lead to enhanced awareness, recognition, and treatment of hypopituitarism, which can have life-saving ramifications and enhance quality of life and rehabilitation efforts in our combat veterans.
Read the detailed description
The prevalence of hypopituitarism after combat-related traumatic brain injury (TBI) is currently unknown. Recent civilian data on TBI show the prevalence of any pituitary hormone deficiency is as high as 80% after 12 months. While the military prevalence of hypopituitarism can be extrapolated from civilian data, a major limitation is the notably different mechanism of injury (i.e., blast) for military personnel compared to civilians (i.e., assaults, traffic accidents and falls). Little is known about the effect of shockwaves from a blast injury on central nervous system tissue, and due to the unique nature of blast-related TBI, the prevalence of pituitary dysfunction in affected service members may significantly differ from nonmilitary subjects in prior studies.
- Conditions
- Traumatic Brain Injury, Hypopituitarism
- Being tested
- Blast Traumatic Brain Injury
- Keywords
- Traumatic brain injury, hypopituitarism
- Medical subject headings
- Brain Injuries, Traumatic, Hypopituitarism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blast Traumatic Brain InjuryOther
Also called bTBI
Exposure during combat to blast-wave mediated Traumatic Brain Injury
| Study group | Role | What they receive |
|---|---|---|
| 3 months post-injury | Male and female combat veterans age 18 years and older with the diagnosis of Traumatic Brain Injury caused by a blast that occurred 3 months prior to enrollment, 50% mild, 50% moderate and severe Receives: Other: Blast Traumatic Brain Injury | |
| 6 months post-injury | Male and female combat veterans age 18 years and older with the diagnosis of Traumatic Brain Injury caused by a blast that occurred 6 months prior to enrollment, 50% mild, 50% moderate and severe Receives: Other: Blast Traumatic Brain Injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of anterior pituitary dysfunction
Pituitary screening blood tests: cortisol, follicle stimulating hormone, luteinizing hormone, total testosterone (males) or estradiol (females), thyrotropin, free thyroxine, prolactin, insulin-like growth factor-1. Growth-hormone deficiency will be confirmed with a glucagon stimulation test. Adrenal Insufficiency will be confirmed with an Cosyntropin stimulation test.
Measured: at 3 (+/- 15 days) and 6 months (+/- 15 days)
Secondary outcomes (1)
Prevalence of posterior pituitary dysfunction
Pituitary Dysfunction: Screening Sodium. Diabetes Insipidus will be confirmed with a water deprivation test.
Measured: at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2014 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- Andrew J. Brackbill, M.D., Principal investigator, WalterReed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666964
- Sponsor's protocol ID
- 350758-12
- Status last verified
- Aug 2012
- First submitted
- 14 Aug 2012
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hypopituitarism Following Combat-related Traumatic Brain Injury in a Military Population
- ClinicalTrials.gov ID
- NCT01666964
- Acronym / sponsor ID
- 350758-12
- Conditions
- Traumatic Brain Injury, Hypopituitarism
- Keywords
- Traumatic brain injury, hypopituitarism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Collaborators
- Novo Nordisk A/S
- Study start
- Oct 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 16 Aug 2012 (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.
We would like to ascertain the prevalence of hypopituitarism after combat-related TBI. This will lead to enhanced awareness, recognition, and treatment of hypopituitarism, which can have life-saving ramifications and enhance quality of life and rehabilitation efforts in our combat veterans.
Detailed description
The prevalence of hypopituitarism after combat-related traumatic brain injury (TBI) is currently unknown. Recent civilian data on TBI show the prevalence of any pituitary hormone deficiency is as high as 80% after 12 months. While the military prevalence of hypopituitarism can be extrapolated from civilian data, a major limitation is the notably different mechanism of injury (i.e., blast) for military personnel compared to civilians (i.e., assaults, traffic accidents and falls). Little is known about the effect of shockwaves from a blast injury on central nervous system tissue, and due to the unique nature of blast-related TBI, the prevalence of pituitary dysfunction in affected service members may significantly differ from nonmilitary subjects in prior studies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 months post-injury | – | Other: Blast Traumatic Brain InjuryMale and female combat veterans age 18 years and older with the diagnosis of Traumatic Brain Injury caused by a blast that occurred 3 months prior to enrollment, 50% mild, 50% moderate and severe |
| 6 months post-injury | – | Other: Blast Traumatic Brain InjuryMale and female combat veterans age 18 years and older with the diagnosis of Traumatic Brain Injury caused by a blast that occurred 6 months prior to enrollment, 50% mild, 50% moderate and severe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female combat veterans age 18 years and older with the diagnosis of Traumatic Brain Injury that occurred 3 and 6 months prior to enrollment.
Key inclusion criteria (3 listed)
- Combat veterans who are 3 or 6 months post combat-related TBI and age 18yrs or older
- Must demonstrate capacity for informed consent
- Must be DEERS eligible (Military healthcare beneficiary)
Key exclusion criteria (5 listed)
- Pregnancy (to be assessed by urine HCG)
- Use of hormonal contraceptives
- Chronic oral or intravenous glucocorticoids
- Use of hormonal therapy to include estrogen and testosterone
- Prior diagnosis of hypopituitarism prior to combat related TBI
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 |
|---|---|---|
| Blast Traumatic Brain InjuryAlso: bTBIExposure during combat to blast-wave mediated Traumatic Brain Injury | Other | 3 months post-injury, 6 months post-injury |
Primary outcome
Prevalence of anterior pituitary dysfunction
Time frame: at 3 (+/- 15 days) and 6 months (+/- 15 days)
Pituitary screening blood tests: cortisol, follicle stimulating hormone, luteinizing hormone, total testosterone (males) or estradiol (females), thyrotropin, free thyroxine, prolactin, insulin-like growth factor-1. Growth-hormone deficiency will be confirmed with a glucagon stimulation test. Adrenal Insufficiency will be confirmed with an Cosyntropin stimulation test.
1 secondary outcome
Prevalence of posterior pituitary dysfunction
Time frame: at 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2012.
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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.
Andrew J. Brackbill, M.D. principal investigator
WalterReed National Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Hypopituitarism, run by Walter Reed National Military Medical Center at 1 site in United States.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew J Brackbill, M.D. (301-295-5183, tbiendocrine@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of anterior pituitary dysfunction (time frame: at 3 (+/- 15 days) and 6 months (+/- 15 days)). It is what the study was designed to measure, not a finding.
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 16 Aug 2012.