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 range

18 Years – 65 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Trial details

NCT IDNCT01512524

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-05

View on ClinicalTrials.gov More Traumatic Brain Injury (TBI) trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.