Hormonal Deficiency in the Quality of Life of Patients With Traumatic Brain Injury (NCT01512524) | Clinical Trial Compass
CompletedNot Applicable
Hormonal Deficiency in the Quality of Life of Patients With Traumatic Brain Injury
France88 participantsStarted 2011-11-23
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
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.