Clinical trial NCT01512524: Hormonal Deficiency in the Quality of Life of Patients With Traumatic Brain Injury
Official title: Long Term Follow-up of Moderate and Severe Traumatic Bain Injury and Assessment of Involvement of Hormonal Deficiency in the Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Brain Injury (TBI)
Keywords: Traumatic Brain Injury
Quality of Life (QoL)
hypopituitarism,GH
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-01-19
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective is to assess the long-term impact of hormonal deficiency on Quality of Life (QoL) in a large group of moderate and severe Traumatic Brain Injury (TBI) patients.

Detailed description: Severe Traumatic Brain Injury, when not leading to mortality, is a major cause of morbidity in early adulthood.

Recent studies have demonstrated a previously unappreciated association between Severe Traumatic Brain Injury and endocrine dysfunction.

The current trial aims at evaluating the quality of life 18 months post-trauma and associating this outcome to growth hormone levels.

Eligibility criteria: Inclusion Criteria:

* All subjects must be between the ages of 18-65
* Documented moderate to severe Traumatic Brain Injury (TBI) at less than 4 months post injury.
* Glasgow Coma Scale (GCS) equal to or greater than 12
* Patients volunteer to participate in the study, with a written informed consent signed
* BMI between 17 kg/m2 - 30kg/m2
* Affiliation to a national health insurance program

Exclusion Criteria:

* Glasgow Coma Scale (GCS) ≥13
* History of TBI ≥4 months
* Anterior hypopituitarism documented
* History of radiotherapy
* Liver dysfunction: total bilirubin \<20µmol/l and/or factor V\<60%)
* Renal dysfunction: creatinine clearance \< 30 ml/mn (Cockcroft \& Gault)
* Anyone who is currently taking or who has taken corticotherapy in the last 4 weeks before TBI
* Pregnancy
* Contraindications to MRI:
* Patients who have a heart pacemaker
* Patients who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain
* Patients with severe claustrophobia

Primary outcomes:
measure: Evolution of the SF-36(Short-Form health survey)score up to 18 months post-trauma
timeFrame: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.
Secondary outcomes:
measure: QOLIBRI (Quality of Life after Brain Injury) measure #1
timeFrame: assessed at 4 months (M4), 12 months (M12)and 18 months (M18) after brain injury.
measure: Questions on Life Satisfaction-Hypopituitarism (QLS-H) measure #2
timeFrame: Time frame: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.
measure: Tests of Attentional, mnesic and executive performances #3
timeFrame: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.
measure: Functional outcomes (#4):The Glasgow Outcome Scale (GOS)-Score
timeFrame: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.
measure: Functional outcome #5 :the Functional Independence Measure (FIM)
timeFrame: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.
Other outcomes:
Locations:
city: Lyon
country: France
facility: French University Hospital
state: Rhône Alpes
Study officials:
affiliation: Hôpital Henry Gabrielle, Hospices Civils de Lyon
name: Sophie Courtois, MD
role: PRINCIPAL_INVESTIGATOR
References: