An observational study in Traumatic Brain Injury and Hypopituitarism, sponsored by Walter Reed National Military Medical Center. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-16.
Sponsored by Walter Reed National Military Medical Center · Observational
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.
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.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 200 is above the median of 117 across 557 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Walter Reed National Military Medical Center is the lead sponsor of 78 studies on the registry; 20 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: Blast Traumatic Brain 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
Other: Blast Traumatic Brain Injury
Exposure during combat to blast-wave mediated Traumatic Brain Injury
Also known as: bTBI
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.
Time frame: at 3 (+/- 15 days) and 6 months (+/- 15 days)
Prevalence of posterior pituitary dysfunction
Pituitary Dysfunction: Screening Sodium. Diabetes Insipidus will be confirmed with a water deprivation test.
Time frame: at 3 and 6 months
Background prevalence of hypopituitarism in a military population using the Department of Defense serum repository
Screening labs for pituitary dysfunction repeated on frozen serum obtained prior to injury.
Time frame: At completion of Enrollment
Relationship between hypopituitarism secondary to combat-related TBI and symptom scores using the Neurobehavioral Symptom Index.
The Neurobehavioral Symptom Index is a validated measure of cognitive and somatic symptoms after Traumatic Brain Injury.
Time frame: 3 and 6 months post-injury
The record gives a start of Oct 2012, a primary completion of Dec 2014 and a completion of May 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Walter Reed National Military Medical Center