Hormonal Deficiency in the Quality of Life of Patients With Traumatic Brain Injury (INSPIRE-TC)

Civil Hospices of Lyon

Status: Completed

Conditions: Traumatic Brain Injury (TBI)

Treatments: Other: MRI scan and endocrinology analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT01512524

2010.641

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

Patients With Traumatic Brain Injury

Other group

Description:

Study of the association between quality of life and MRI scans and endocrinology analysis (quantification of Growth Hormone) 18 months post-trauma.

Treatment:

Other: MRI scan and endocrinology analysis