Moderate to Severe Traumatic Brain InjuryEndoc-TCNCT01250132
Ante-hypophyseal Dysfunctions in Children Following Moderate to Severe Traumatic Brain Injuries
A study testing Biological and behavioral explorations in people with Moderate to Severe Traumatic Brain Injury, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Annual incidence of severe traumatic brain injuries (TBI) varies from 180 to 300 out of 100.000. Mortality or severe sequelae risk is increased 8 fold after a TBI. Studies in adults showed an ante-hypophyseal deficit in 28 to 68 % of patients with a TBI. Read more about this study
- Who is it for?
- Ages 2 months to 16 years
- Conditions the study is for
- Moderate to Severe Traumatic Brain Injury
- What is being tested?
- Biological and behavioral explorations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2010to 13 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children from 2 months to 16 years
- in the intensive care unit
- TBI : moderate (Glasgow Coma Scale (GCS) between 9 and 12) to severe (GCS <9), whatever the mechanism involved
- informed consent form signed by parents
Who cannot join
- obesity (Body Mass Index (BMI) > 97th percentile for the age)
- patient already under replacement therapy.
- patient taking AntiEpileptic Drugs (AEDs)
- patient with long-term systemic corticotherapy
- history of neurological disease or learning difficulties
- no covered by a national health insurance
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Grenoble
Grenoble, 38 000
Hospices Civils de Lyon
Lyon, 69000
About this study
Official title: Are Ante-hypophyseal Dysfunctions in the Acute Phase of Moderate to Severe Traumatic Brain Injury Predictive of Long-term Ante-hypophyseal Sequelae in Children?
Annual incidence of severe traumatic brain injuries (TBI) varies from 180 to 300 out of 100.000. Mortality or severe sequelae risk is increased 8 fold after a TBI. Studies in adults showed an ante-hypophyseal deficit in 28 to 68 % of patients with a TBI. The most common deficit is Growth Hormone Deficit (GHD); followed by gonadotropic and corticotropic (AdrenoCorticoTropic Hormone (ACTH)) insufficiencies. Thyrotropic deficits (Thyroid-Stimulating Hormone (TSH)) are less frequent. From a pathophysiological point of view, the lesional mechanism responsible for hypopituitarisms would be a damage of hypophyseal vessels or hypothalamic-pituitary vessels. The frequency of pituitary deficits and the potential beneficial effects of replacement therapy on quality of life, tiredness, loss of energy and productivity, justify the systematic detection of the deficits in patients with moderate to severe TBI.
Study hypotheses :
Read more
At the present time, the lack of data in children does not give us the opportunity to affirm that one part of the symptoms showed by children with post-TBI neuropsychological sequelae, are linked to pituitary deficiency and that they can be improved with a replacement therapy.
Firstly, it is essential to better understand the natural history of post-TBI pituitary deficiencies, studying the connexion between observed deficiencies in acute and late phase of sequelae.
- Being tested
- Biological and behavioral explorations
- Keywords
- Traumatic brain injury, Paediatrics, Hypopituitarism
- Medical subject headings
- Brain Injuries, Traumatic, Hypopituitarism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological and behavioral explorationsOther
Blood dosages:
- biochemistry
- pituitary gland
- somatotropic axis
- corticotropic axis
- gonadotropic axis
- thyrotropic axis
- antidiuretic axis
Questionnaires and scales (quality of life, Vineland Adaptive Behavior Scales (VABS)-II)
| Study group | Role | What they receive |
|---|---|---|
| Moderate to severe Traumatic Brain Injury | Other | Assessment of hypopituitarism. Blood tests at different moments:
* day 0
* when leaving intensive care unit
* month 3
* month 12 Receives: Other: Biological and behavioral explorations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the link between pituitary deficiencies highlighted at the acute phase and one year after moderate to severe TBI.
Measured: 12 months after inclusion
Secondary outcomes (4)
Study the association between pituitary deficiencies highlighted at the acute phase, 3 months and 1 year after moderate to severe TBI, globally and per deficiency category.
Measured: day0, when leaving intensive care unit, month3 and month12
Identify the other risk factors of deficiency, during the acute phase and the tardive phase i.e. signs of gravity of the TBI, type of cerebral lesion, age, lesional mechanism.
Measured: day0, when leaving intensive care unit, month3 and month12
Study the correlation between corticotropic deficiencies and post-hypophysis insufficiencies during the acute phase and the hemodynamic instability over the first 3 days after the TBI
Measured: day0 to day3
Compare the level and the type of behavioural and neuropsychological sequelae in children suffering from a TBI, with and without hypopituitarism.
Measured: day0, when leaving intensive care unit, month3 and month12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startOct 2010
- Primary completion13 Apr 2018
- Study completion13 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne JAVOUHEY, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250132
- Sponsor's protocol ID
- 2010.599
- Acronym
- Endoc-TC
- Status last verified
- Aug 2019
- First submitted
- 25 Nov 2010
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Ante-hypophyseal Dysfunctions in the Acute Phase of Moderate to Severe Traumatic Brain Injury Predictive of Long-term Ante-hypophyseal Sequelae in Children?
- ClinicalTrials.gov ID
- NCT01250132
- Acronym / sponsor ID
- Endoc-TC / 2010.599
- Keywords
- Traumatic brain injury, Paediatrics, Hypopituitarism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2010 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 13 Apr 2018 (actual)
- First posted
- 30 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Annual incidence of severe traumatic brain injuries (TBI) varies from 180 to 300 out of 100.000. Mortality or severe sequelae risk is increased 8 fold after a TBI. Studies in adults showed an ante-hypophyseal deficit in 28 to 68 % of patients with a TBI. The most common deficit is Growth Hormone Deficit (GHD); followed by gonadotropic and corticotropic (AdrenoCorticoTropic Hormone (ACTH)) insufficiencies. Thyrotropic deficits (Thyroid-Stimulating Hormone (TSH)) are less frequent. From a pathophysiological point of view, the lesional mechanism responsible for hypopituitarisms would be a damage of hypophyseal vessels or hypothalamic-pituitary vessels. The frequency of pituitary deficits and the potential beneficial effects of replacement therapy on quality of life, tiredness, loss of energy and productivity, justify the systematic detection of the deficits in patients with moderate to severe TBI.
Study hypotheses :
At the present time, the lack of data in children does not give us the opportunity to affirm that one part of the symptoms showed by children with post-TBI neuropsychological sequelae, are linked to pituitary deficiency and that they can be improved with a replacement therapy.
Firstly, it is essential to better understand the natural history of post-TBI pituitary deficiencies, studying the connexion between observed deficiencies in acute and late phase of sequelae.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate to severe Traumatic Brain Injury | Other | Other: Biological and behavioral explorationsAssessment of hypopituitarism. Blood tests at different moments: * day 0 * when leaving intensive care unit * month 3 * month 12 |
Who may qualify
- Ages
- 2 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children from 2 months to 16 years
- in the intensive care unit
- TBI : moderate (Glasgow Coma Scale (GCS) between 9 and 12) to severe (GCS <9), whatever the mechanism involved
- informed consent form signed by parents
Key exclusion criteria (6 listed)
- obesity (Body Mass Index (BMI) > 97th percentile for the age)
- patient already under replacement therapy.
- patient taking AntiEpileptic Drugs (AEDs)
- patient with long-term systemic corticotherapy
- history of neurological disease or learning difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological and behavioral explorationsBlood dosages: * biochemistry * pituitary gland * somatotropic axis * corticotropic axis * gonadotropic axis * thyrotropic axis * antidiuretic axis Questionnaires and scales (quality of life, Vineland Adaptive Behavior Scales (VABS)-II) | Other | Moderate to severe Traumatic Brain Injury |
Primary outcome
Study the link between pituitary deficiencies highlighted at the acute phase and one year after moderate to severe TBI.
Time frame: 12 months after inclusion
4 secondary outcomes
Study the association between pituitary deficiencies highlighted at the acute phase, 3 months and 1 year after moderate to severe TBI, globally and per deficiency category.
Time frame: day0, when leaving intensive care unit, month3 and month12
Identify the other risk factors of deficiency, during the acute phase and the tardive phase i.e. signs of gravity of the TBI, type of cerebral lesion, age, lesional mechanism.
Time frame: day0, when leaving intensive care unit, month3 and month12
Study the correlation between corticotropic deficiencies and post-hypophysis insufficiencies during the acute phase and the hemodynamic instability over the first 3 days after the TBI
Time frame: day0 to day3
Compare the level and the type of behavioural and neuropsychological sequelae in children suffering from a TBI, with and without hypopituitarism.
Time frame: day0, when leaving intensive care unit, month3 and month12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne JAVOUHEY, MD, PhD principal investigator
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological and behavioral explorations in people with Moderate to Severe Traumatic Brain Injury, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the link between pituitary deficiencies highlighted at the acute phase and one year after moderate to severe TBI. (time frame: 12 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.