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Hormone Deficiency After Brain Injury During Combat

NCT ID: NCT01666964

Last Updated: 2012-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-05-31

Brief Summary

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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

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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

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Traumatic Brain Injury Hypopituitarism

Keywords

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Traumatic brain injury hypopituitarism

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Blast Traumatic Brain Injury

Intervention Type OTHER

Exposure during combat to blast-wave mediated 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

Blast Traumatic Brain Injury

Intervention Type OTHER

Exposure during combat to blast-wave mediated Traumatic Brain Injury

Interventions

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Blast Traumatic Brain Injury

Exposure during combat to blast-wave mediated Traumatic Brain Injury

Intervention Type OTHER

Other Intervention Names

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bTBI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew J. Brackbill, M.D.

Role: PRINCIPAL_INVESTIGATOR

WalterReed National Military Medical Center

Locations

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Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status

Countries

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United States

Central Contacts

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Andrew J Brackbill, M.D.

Role: CONTACT

Phone: 301-295-5183

Email: [email protected]

Other Identifiers

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350758-12

Identifier Type: -

Identifier Source: org_study_id