Suspended

Prevalence of Hypopituitarism Following Combat-related Traumatic Brain Injury in a Military Population

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What is being collected

Data Collection

+ other Data

Collected from today forward - Prospective
OtherNo DNA Sample
Who is being recruted

Brain Diseases+9

+ Brain Injuries

+ Central Nervous System Diseases

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: October 2012
See protocol details

Summary

Principal SponsorWalter Reed National Military Medical Center
Study ContactAndrew J Brackbill, M.D.More contacts
Last updated: August 16, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01666964
Principal SponsorWalter Reed National Military Medical Center
Study ContactAndrew J Brackbill, M.D.More contacts
Last updated: August 16, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesBrain InjuriesCentral Nervous System DiseasesEndocrine System DiseasesCraniocerebral TraumaHypothalamic DiseasesNervous System DiseasesPituitary DiseasesWounds and InjuriesTrauma, Nervous SystemBrain Injuries, TraumaticHypopituitarism

Criteria

3 inclusion criteria required to participate
Combat veterans who are 3 or 6 months post combat-related TBI and age 18yrs or older
Must be DEERS eligible (Military healthcare beneficiary)
Must demonstrate capacity for informed consent
5 exclusion criteria prevent from participating
Chronic oral or intravenous glucocorticoids
Pregnancy (to be assessed by urine HCG)
Prior diagnosis of hypopituitarism prior to combat related TBI
Use of hormonal contraceptives
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Walter Reed National Military Medical Center

Bethesda, United StatesOpen Walter Reed National Military Medical Center in Google Maps
SuspendedOne Study Center