Hormonal Deficiency in the Quality of Life of Patients With Traumatic Brain Injury

Not Applicable

• Conditions: Traumatic Brain Injury (TBI)

• Registration Number: NCT01512524
• Lead Sponsor: Hospices Civils de Lyon

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-29
• Study First Submitted QC: 2012-01-15
• Study First Posted: 2012-01-19
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-21
• Last Update Posted: 2014-03-24
• Primary Completion: 2017-06
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evolution of the SF-36(Short-Form health survey)score up to 18 months post-trauma	assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.

Secondary Outcome Measures

Name	Time	Method
QOLIBRI (Quality of Life after Brain Injury) measure #1	assessed at 4 months (M4), 12 months (M12)and 18 months (M18) after brain injury.
Questions on Life Satisfaction-Hypopituitarism (QLS-H) measure #2	Time frame: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.
Tests of Attentional, mnesic and executive performances #3	assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.	Tests of Attentional, mnesic and executive performances: - Alertness; * Sustained Attention; * Divided Attention; * Go/NoGo; * Working Memory; * Incompatibility; * Flexibility; * Grober and Buschke test; * Rey's complex figure (copy and memory)
Functional outcomes (#4):The Glasgow Outcome Scale (GOS)-Score	assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.
Functional outcome #5 :the Functional Independence Measure (FIM)	assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.

Trial Locations

Locations (1)

French University Hospital; 🇫🇷 Lyon, Rhône Alpes, France