The PIT-TBI Pilot Study

Traumatic Brain Injury Clinical Trial

Official title:

Clinical Outcomes and Predictors of PITuitary Disorders in Patients With Moderate and Severe Traumatic Brain Injury: the PIT-TBI Prospective Multicenter Pilot Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02480985
• Other study ID #: C14-06-2040-21
• Status: Active, not recruiting
• Phase: N/A
• First received: June 18, 2015
• Last updated: March 24, 2017
• Start date: March 2015
• Est. completion date: March 2018

Study information

• Verified date: March 2017
• Source: Centre Hospitalier Universitaire de Québec, CHU de Québec
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Pituitary Diseases
• Pituitary Disorders
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• Pituitary function evaluation
Pituitary function evaluation performed at hospital discharge, 6 and 12 months Thyroid-stimulating hormone, free T4 and T3 Follicle stimulating hormone, luteinizing hormone, estradiol, bioavailable testosterone Adrenocorticotropic hormone stimulation test Glucagon test (growth hormone deficit) Risk factors evaluation of pituitary dysfunction Demographic data Daily data (clinical exam, secondary brain injuries) Hormone levels on day 1, 3 and 7 Biomarkers on day 1, 3 and 7 Brain CT-Scan on day 1 Pituitary MRI on day 7 Outcome measures at 6 and 12 months Neurological recovery (GOSe) Independent functioning (FIM) Quality of life (EQ-5D-5L) Life satisfaction (LISAT-11) Depression (PHQ-9)

Locations

Country	Name	City	State
Canada	Hôpital du Sacré-Coeur de Montréal	Montreal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	CHU de Québec - Hôpital de l'Enfant-Jésus	Quebec
Canada	CHU de Sherbrooke - Hôpital Fleurimont	Sherbrooke	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Québec, CHU de Québec	Canadian Critical Care Trials Group, Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Lauzier F, Turgeon AF, Boutin A, Shemilt M, Côté I, Lachance O, Archambault PM, Lamontagne F, Moore L, Bernard F, Gagnon C, Cook D. Clinical outcomes, predictors, and prevalence of anterior pituitary disorders following traumatic brain injury: a systematic review. Crit Care Med. 2014 Mar;42(3):712-21. doi: 10.1097/CCM.0000000000000046. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to the Protocol	Percentage of participants who underwent pituitary function evaluation and outcome measures as detailed in the Assigned Interventions section	12 months
Primary	Enrollment Rate	Number of patients recruited per month per site	12 months
Secondary	Neurological Recovery	Glasgow Outcome Scale Extended (GOSe)	12 months
Secondary	Quality of life	EuroQuol - EQ-5D-5L questionnaire	12 months
Secondary	Independent functioning	Functional Independence Measure (FIM) questionnaire	12 months
Secondary	Depression	Patient Health Questionnaire (PHQ-9)	12 months
Secondary	Life satisfaction	Life Satisfaction Questionnaire (LISAT)	12 months
Secondary	Secondary hypothyroidism		12 months
Secondary	Secondary hypogonadism		12 months
Secondary	Secondary adrenal insufficiency		12 months
Secondary	Growth hormone deficit		12 months

External Links

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