The PIT-TBI Pilot Study

Laval University

Status: Unknown

Conditions: Traumatic Brain Injury; Pituitary Disorders

Treatments: Other: Pituitary function evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT02480985

C14-06-2040-21

Details and patient eligibility

About

Damage to the pituitary gland is a frequently overlooked but potentially important complication of traumatic brain injury (TBI). Disorders of the pituitary gland can cause dysfunction of the thyroid, adrenals, ovaries and testes. These disorders may occur immediately or several months after TBI, may delay recovery and may have a significant negative impact on quality of life. TBI is the leading cause of disability and major permanent functional impairment among adults under 45 years of age. Hormonal deficits may contribute to common symptoms experienced by TBI survivors such as fatigue, poor concentration, depression and low exercise capacity. However, the association between hormonal deficits and disability remains uncertain. The primary objective of this pilot study is to assess the feasibility of a larger study that will evaluate the impact of pituitary disorders on neurological disability and functional recovery. The results of this study will provide key findings in the impact of pituitary disorders following TBI, which is a mandatory step prior testing the effect of hormonal replacement therapy in this population in costly clinical trials. If no relationship between pituitary disorders and disability is observed, the investigators' findings will prevent unnecessary, time-consuming and costly hormonal screening and will discourage potentially harmful hormonal therapy.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (≥ 18 years old)
• Severe or moderate blunt TBI admitted to the ICU with a Glasgow Coma Scale ≤ 12 following initial resuscitation

Exclusion criteria

• Previously diagnosed or suspected pituitary disorder or disease
• Pregnant or lactating woman
• Penetrating TBI
• Solid malignancy with life expectation <12 months
• Liver Cirrhosis Child C
• Chronic Heart Failure (New York Heart Association class IV)
• End-stage chronic respiratory disease (O2 dependent)
• End-stage renal disease (chronic dialysis or to be expected)
• Neurological conditions influencing functional status (e.g. spinal cord injury, neuromuscular disease, dementia, prior TBI or stroke)
• No fixed address
• Physician refusal
• Brain death
• Unable to return to the study center to attend the follow-up visits
• Admission to the Intensive Care Unit of the participating center > 24 hours after TBI

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

70 participants in 1 patient group

Pituitary function evaluation

Other group

Description:

Exams performed according to a determined schedule following admission in the intensive care unit in order to determine the risk factors and the outcome associated with pituitary disorders.

Treatment:

Other: Pituitary function evaluation