Status:
COMPLETED
Hormonal Deficiency in the Quality of Life of Patients With Traumatic Brain Injury
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Traumatic Brain Injury (TBI)
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 23 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT01512524
Start Date
November 23 2011
End Date
May 1 2017
Last Update
December 19 2025
Active Locations (1)
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1
French University Hospital
Lyon, Auvergne-Rhône-Alpes, France, 69000