The PIT-TBI Pilot Study

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02480985
• Date of registration: 18/06/2015
• Prospective Registration: No
• Primary sponsor: CHU de Quebec-Universite Laval
• Public title: The PIT-TBI Pilot Study
• Scientific 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
• Date of first enrolment: March 2015
• Target sample size: 70
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02480985
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: François Lauzier, MD MSc FRCPC
• Affiliation: CHU de Quebec Research Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pituitary Disorders

Traumatic Brain Injury

Intervention(s)

Other: Pituitary function evaluation

Primary Outcome(s)

Enrollment Rate [Time Frame: 12 months]

Adherence to the Protocol [Time Frame: 12 months]

Secondary Outcome(s)

Secondary adrenal insufficiency [Time Frame: 12 months]

Secondary hypogonadism [Time Frame: 12 months]

Growth hormone deficit [Time Frame: 12 months]

Independent functioning [Time Frame: 12 months]

Neurological Recovery [Time Frame: 12 months]

Quality of life [Time Frame: 12 months]

Depression [Time Frame: 12 months]

Secondary hypothyroidism [Time Frame: 12 months]

Life satisfaction [Time Frame: 12 months]

Secondary ID(s)

C14-06-2040-21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fonds de la Recherche en Santé du Québec

Canadian Institutes of Health Research (CIHR)

Canadian Critical Care Trials Group