The PIT-TBI Pilot Study

NCT ID: NCT02480985

Last Updated: 2017-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2018-03-31

Brief 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.

Conditions

Pituitary Disorders; Traumatic Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Pituitary function evaluation

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.

Group Type: OTHER

Pituitary function evaluation

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Canadian Critical Care Trials Group

OTHER

Sponsor Role: collaborator

Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role: collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: lead

Responsible Party

François Lauzier

MD MSc FRCPC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

François Lauzier, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

CHU de Quebec Research Center

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, Canada

CHU de Québec - Hôpital de l'Enfant-Jésus

Québec, Quebec, Canada

CHU de Sherbrooke - Hôpital Fleurimont

Sherbrooke, Quebec, Canada

Countries

Canada

References

Lauzier F, Turgeon AF, Boutin A, Shemilt M, Cote 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.

Reference Type: BACKGROUND

PMID: 24247474 (View on PubMed)

Related Links

http://www.ccctg.ca

Related Info

Other Identifiers

C14-06-2040-21

Identifier Type: -

Identifier Source: org_study_id