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Traumatic Brain Injury | Hormone Deficiency After Brain Injury During Combat

Traumatic Brain Injury research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - 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) Exclusion Criteria: - 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Traumatic Brain Injury

Hypopituitarism

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Blast Traumatic Brain InjuryExposure during combat to blast-wave mediated Traumatic Brain Injury

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

3 months post-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-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

Study Status

Unknown status

Start Date: October 2012

Completed Date: May 2015

Phase:

Type: Observational

Design:

Primary Outcome: Prevalence of anterior pituitary dysfunction

Secondary Outcome: Prevalence of posterior pituitary dysfunction

Study sponsors, principal investigator, and references

Principal Investigator: Andrew J. Brackbill, M.D.

Lead Sponsor: Walter Reed National Military Medical Center

Collaborator: Novo Nordisk A/S

More information:https://clinicaltrials.gov/show/NCT01666964

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