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

NCT ID: NCT01512524

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-23

Study Completion Date

2017-05-31

Brief Summary

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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

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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.

Conditions

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Traumatic Brain Injury (TBI)

Keywords

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Traumatic Brain Injury Quality of Life (QoL) hypopituitarism,GH

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients With Traumatic Brain Injury

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

Group Type OTHER

MRI scan and endocrinology analysis

Intervention Type OTHER

Endocrinology analysis including statique and dynamic exams, neuropsychologic evaluations and IRM scan.

Interventions

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MRI scan and endocrinology analysis

Endocrinology analysis including statique and dynamic exams, neuropsychologic evaluations and IRM scan.

Intervention Type OTHER

Other Intervention Names

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MRI scan endocrinology analysis

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sophie Courtois, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Henry Gabrielle, Hospices Civils de Lyon

Locations

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French University Hospital

Lyon, Auvergne-Rhône-Alpes, France

Site Status

Countries

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France

Other Identifiers

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2010.641

Identifier Type: -

Identifier Source: org_study_id