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

Not Applicable

• Conditions: Traumatic Brain Injury (TBI)
• Interventions: Other: MRI scan and endocrinology analysis

• 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

Arm && Interventions

Group	Intervention	Description
Patients With Traumatic Brain Injury	MRI scan and endocrinology analysis	Study of the association between quality of life and MRI scans and endocrinology analysis (quantification of Growth Hormone) 18 months post-trauma.

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