Hormone Deficiency After Brain Injury During Combat

Walter Reed National Military Medical Center

Status: Unknown

Conditions: Traumatic Brain Injury; Hypopituitarism

Treatments: Other: Blast Traumatic Brain Injury

Study type: Observational

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT01666964

350758-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

3 months post-injury

Description:

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

Treatment:

Other: Blast Traumatic Brain Injury

6 months post-injury

Description:

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

Treatment:

Other: Blast Traumatic Brain Injury