NCT02480985

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

3 years

First QC Date

June 18, 2015

Last Update Submit

March 24, 2017

Conditions

Pituitary DisordersTraumatic Brain Injury

Keywords

Pituitary DisordersTraumatic Brain InjuryCritical CareOutcome ResearchRisk FactorsPatient Oriented Research

Outcome Measures

Primary Outcomes (2)

  • Adherence to the Protocol

    Percentage of participants who underwent pituitary function evaluation and outcome measures as detailed in the Assigned Interventions section

    12 months

  • Enrollment Rate

    Number of patients recruited per month per site

    12 months

Secondary Outcomes (9)

  • Neurological Recovery

    12 months

  • Quality of life

    12 months

  • Independent functioning

    12 months

  • Depression

    12 months

  • Life satisfaction

    12 months

  • +4 more secondary outcomes

Study Arms (1)

Pituitary function evaluation

OTHER

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.

Other: Pituitary function evaluation

Interventions

Pituitary function evaluationOTHER

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)

Pituitary function evaluation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, Canada

Location

CHU de Québec - Hôpital de l'Enfant-Jésus

Québec, Quebec, Canada

Location

CHU de Sherbrooke - Hôpital Fleurimont

Sherbrooke, Quebec, Canada

Location

Related Publications (1)

  • 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.

    PMID: 24247474BACKGROUND

Related Links

MeSH Terms

Conditions

Pituitary DiseasesBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Hypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • François Lauzier, MD MSc FRCPC

    CHU de Quebec Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD MSc FRCPC

Study Record Dates

First Submitted

June 18, 2015

First Posted

June 25, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

CA(5)