Traumatic Brain InjuryNCT04651803
Outcome in Traumatic Brain Injury Elderly Patients
An observational study of Traumatic Brain Injury, run by Association pour la Recherche en Aanesthésie Réanimation Digestive.
Trial summary
In patients suffering from traumatic brain injury (TBI), the study's purpose was to determinate factors associated with mortality and poor functional outcome at 3 months in patients aged ≥ 65 hospitalized in ICU and to compare outcome at 3 months between younger patients (18-64 years) vs older patients (≥65 years). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 1,633 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Jun 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Traumatic brain injury
Who may be able to join
- Traumatic brain injury
- Aged at least 18 years,
- Hospitalized in intensive care unit
Who cannot join
- Patients who die within 24h of hospitalization
- Patients initially resuscitated awaiting for organ donation
- Refusal for study participation expressed by the patient or relatives.
- Missing data related to the main objective of the study (outcome at 3 months)
About this study
Official title: Factors Associated With Unfavorable Outcome in Traumatic Brain Injury Elderly Patients. A Retrospective Multicenter Study
In patients suffering from traumatic brain injury (TBI), the study's purpose was to determinate factors associated with mortality and poor functional outcome at 3 months in patients aged ≥ 65 hospitalized in ICU and to compare outcome at 3 months between younger patients (18-64 years) vs older patients (≥65 years).
Traumatic brain injury is a common cause of hospitalization for trauma and accounting for roughly 37% of all injury-related death in Europe. This was particularly true for patients ≥ 65 years old and in the most severe case(Glasgow coma score ≤ 8) with mortality rates between 31 to 51%. Over time, epidemiological patterns of TBI are changing. Indeed, in high-income countries, overall incidence is steadily decreasing, but increasing in elderly population with falls becoming the leading cause of TBI. In parallel, the World Population Ageing 2019 report of the Population Division of the United Nations Department of Economic and Social Affairs reported 703 (9%) million persons aged ≥65 years in the global population and that this proportion is projected to rise further to 16 % in 2050. Accordingly, we could expect that TBI in elderly would be increasing and could explain why mortality did not improved in the latest decades.
In a study performed in three neuro-intensive care unit (ICUs) from 1997 to 2007, 6-month mortality in patients aged of 70-79 and ≥ 80 years was 59% and 79%, respectively. In severe elderly (≥ 65 years) TBI patients admitted in ICU, hospital and 6-month mortality was 64.6% and 72.9%, respectively. Beyond mortality, TBI can lead to poor functional neurologic outcome and elderly patients are more prone to survive with disabilities according to a higher rate of comorbidities, frequent use of oral anticoagulants and/or antiplatelet and/or previous brain disorders. In patients hospitalized in ICU, age (> 59 years) was the strongest parameter associated with an unfavorable outcome including death, vegetative state and severe disability, at 6 month. Moreover, TBI elderly patients (≥ 65 years) had worse functional outcome at discharge than younger patients. Identifying elderly patients who may benefit from ICU remained challenging, since there is no consensual guideline of triage. Traumatic brain-injured patients are particularly concerned by this issue. Nevertheless, few data are available related to outcome in elderly TBI patients requiring ICU.
Read the detailed description
The investigators conducted a multicentre, retrospective, observational study from April 2013 to February 2019 in the surgical ICUs of 5 level 1 Trauma centers in France. The investigators collected data from the "regional intensive care network of the great west of france" (AtlanRéa) database. The AtlanRéa database registers prospectively and consecutively numerous informations about brain injury and trauma patients hospitalized in ICUs, in order to provide epidemiologic informations for this population. Data were collected by clinical research assistants in each participating ICU, using an electronic case report form. The investigators assessed data regarding outcomes after discharge from ICUs through phone interview led by dedicated clinical research assistants.
The following data were entered in the database: Age, gender and body mass index, previous medical history, and more specifically the presence of cardiac insufficiency, chronic renal failure defined as an estimated glomerular filtration rate less than 60 ml/min.1.73 m-1, chronic respiratory illness, neurologic background, diabetes, neoplasia history, previous TBI, active smoking and chronic alcoholism. Mechanism of injury (domestic accident, road traffic crash, fall from heights or others). The Glasgow Coma Score (GCS) score determinates in the prehospital setting or at admission at hospital before intubation and/or sedation, and the presence of at least one nonreactive and dilated pupil at the initial management. Severity of illness according to the Simplified Acute Physiology Score II (SAPS II) the Sequential Organ Failure Assessment (SOFA) score, and the Injury Severity Score (ISS). The investigators also specified the severity of TBI by the abbreviated Injury Score (AIS) and reported the associated injuries from 5 territories (face, chest, abdomen, extremity (including pelvis) and external). Initial CT-scan was classified according to the Marshall classification in six categories (Diffuse injury I, II, III, IV, evacuated mass (V) and non-evacuated mass lesion (VI)).
The following data during the patients' hospitalization are also entered in the database: use of an intracranial pressure (ICP) catheter, occurrence of intracranial hypertension (defined as an ICP above 20 mmHg in absence of confounding factors), and use of barbiturates and/or osmotherapy, decompressive craniectomy, and other neurosurgical procedure. The occurrence of intercurrent events occurring during ICU stay, including infections, Acute Respiratory Distress Syndrome (ARDS), need of vasopressor drugs, acute renal failure, thrombophlebitis, pulmonary embolism, hemorrhage, infection and tracheostomy. The investigators specified the need for intubation and durations of mechanical ventilation, central venous catheterism and vasopressor. The investigators also recorded the decision in ICU to withdraw or withhold life support.
The length of stay in ICU, ICU and 3-month mortalities and patient outcome were assessed using the Glasgow Outcome Scale Extended (GOSE) score at 3 months. The investigators dichotomized the GOSE score between the four lower values (corresponding to unfavorable outcome- GOSE 1 to 4) and the four upper values (corresponding to favorable outcome- GOSE 5 to 8).
Statistical Analysis All statistical analysis will be performed using R software 3.3.1 (package pROC) and SAS 9.1 Statistical Software (SAS Institute, Cary, NC, USA). For quantitative continuous variables, position and dispersion parameters (mean, standard deviation, median, interquartile range) will be calculated. For qualitative variables, proportion rates will be calculated. For groups' comparison, we used independent-samples t-tests for normally distributed continuous variables, and Mann-Whitney U-tests for non-normally distributed continuous variables. Χ² tests will be performed for categorical variables. To build the model for multivariate analysis, the investigators selected among the variables with a p ≤ 0.20 according to the univariate analysis. The investigators performed logistic regression model to identify factors associated with in-ICU mortality and dichotomized GOSE score at 3 months. The Odds Ratios (ORs) and 95% confidence intervals (CI) will be calculated. For continuous variables, diagnosis of log linear behavior was established, and if not confirmed, the variable will be divided into categories and treated as categorical variables. Model's fit will be assessed by checking residual plots and Cook's distance. The calibration of the model will be tested by Goodness of Fit Hosmer-Lemeshow test. A p ≤0.05 will be considered statistically significant for all the comparisons.
- Conditions
- Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Traumatic brain injury patients | Traumatic brain injury patients admitted in intensive care unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome was assessed using the Glasgow Outcome Scale Extended (GOSE) score
We dichotomized the GOSE score between the four lower values (corresponding to unfavorable outcome- GOSE 1 to 4) and the four upper values (corresponding to favorable outcome- GOSE 5 to 8).
Measured: GOSE score at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study startApr 2013
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,633 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association pour la Recherche en Aanesthésie Réanimation Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEGUIN Philippe, Association pour la Recherche en Aanesthésie Réanimation Digestive
- Investigators
- Philippe Seguin, MD, PhD, Principal investigator, AtlanRéa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651803
- Sponsor's protocol ID
- ATLANREA
- Status last verified
- Dec 2020
- First submitted
- 26 Nov 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Roozenbeek B, Maas AI, Menon DK. Changing patterns in the epidemiology of traumatic brain injury. Nat Rev Neurol. 2013 Apr;9(4):231-6. doi: 10.1038/nrneurol.2013.22. Epub 2013 Feb 26.
PubMed 23443846Stocchetti N, Paterno R, Citerio G, Beretta L, Colombo A. Traumatic brain injury in an aging population. J Neurotrauma. 2012 Apr 10;29(6):1119-25. doi: 10.1089/neu.2011.1995. Epub 2012 Apr 2.
PubMed 22220762Maiden MJ, Cameron PA, Rosenfeld JV, Cooper DJ, McLellan S, Gabbe BJ. Long-Term Outcomes after Severe Traumatic Brain Injury in Older Adults. A Registry-based Cohort Study. Am J Respir Crit Care Med. 2020 Jan 15;201(2):167-177. doi: 10.1164/rccm.201903-0673OC.
PubMed 31657946Gardner RC, Dams-O'Connor K, Morrissey MR, Manley GT. Geriatric Traumatic Brain Injury: Epidemiology, Outcomes, Knowledge Gaps, and Future Directions. J Neurotrauma. 2018 Apr 1;35(7):889-906. doi: 10.1089/neu.2017.5371. Epub 2018 Feb 15.
PubMed 29212411Lim XT, Ang E, Lee ZX, Hajibandeh S, Hajibandeh S. Prognostic significance of preinjury anticoagulation in patients with traumatic brain injury: A systematic review and meta-analysis. J Trauma Acute Care Surg. 2021 Jan 1;90(1):191-201. doi: 10.1097/TA.0000000000002976.
PubMed 33048909Susman M, DiRusso SM, Sullivan T, Risucci D, Nealon P, Cuff S, Haider A, Benzil D. Traumatic brain injury in the elderly: increased mortality and worse functional outcome at discharge despite lower injury severity. J Trauma. 2002 Aug;53(2):219-23; discussion 223-4. doi: 10.1097/00005373-200208000-00004.
PubMed 12169925De Bonis P, Pompucci A, Mangiola A, Paternoster G, Festa R, Nucci CG, Maviglia R, Antonelli M, Anile C. Decompressive craniectomy for elderly patients with traumatic brain injury: it's probably not worth the while. J Neurotrauma. 2011 Oct;28(10):2043-8. doi: 10.1089/neu.2011.1889. Epub 2011 Aug 29.
PubMed 21639728Pettigrew LE, Wilson JT, Teasdale GM. Reliability of ratings on the Glasgow Outcome Scales from in-person and telephone structured interviews. J Head Trauma Rehabil. 2003 May-Jun;18(3):252-8. doi: 10.1097/00001199-200305000-00003.
PubMed 12802167Majdan M, Plancikova D, Brazinova A, Rusnak M, Nieboer D, Feigin V, Maas A. Epidemiology of traumatic brain injuries in Europe: a cross-sectional analysis. Lancet Public Health. 2016 Dec;1(2):e76-e83. doi: 10.1016/S2468-2667(16)30017-2. Epub 2016 Nov 29.
PubMed 29253420Launey Y, Coquet A, Lasocki S, Dahyot-Fizelier C, Huet O, Le Pabic E, Roquilly A, Seguin P. Factors associated with an unfavourable outcome in elderly intensive care traumatic brain injury patients. a retrospective multicentre study. BMC Geriatr. 2022 Dec 30;22(1):1004. doi: 10.1186/s12877-022-03651-x.
PubMed 36585608
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Unfavorable Outcome in Traumatic Brain Injury Elderly Patients. A Retrospective Multicenter Study
- ClinicalTrials.gov ID
- NCT04651803
- Acronym / sponsor ID
- ATLANREA
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,633 participants (actual)
- Lead sponsor
- Association pour la Recherche en Aanesthésie Réanimation DigestiveUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 3 Dec 2020 (actual)
- 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.
In patients suffering from traumatic brain injury (TBI), the study's purpose was to determinate factors associated with mortality and poor functional outcome at 3 months in patients aged ≥ 65 hospitalized in ICU and to compare outcome at 3 months between younger patients (18-64 years) vs older patients (≥65 years).
Traumatic brain injury is a common cause of hospitalization for trauma and accounting for roughly 37% of all injury-related death in Europe. This was particularly true for patients ≥ 65 years old and in the most severe case(Glasgow coma score ≤ 8) with mortality rates between 31 to 51%. Over time, epidemiological patterns of TBI are changing. Indeed, in high-income countries, overall incidence is steadily decreasing, but increasing in elderly population with falls becoming the leading cause of TBI. In parallel, the World Population Ageing 2019 report of the Population Division of the United Nations Department of Economic and Social Affairs reported 703 (9%) million persons aged ≥65 years in the global population and that this proportion is projected to rise further to 16 % in 2050. Accordingly, we could expect that TBI in elderly would be increasing and could explain why mortality did not improved in the latest decades.
In a study performed in three neuro-intensive care unit (ICUs) from 1997 to 2007, 6-month mortality in patients aged of 70-79 and ≥ 80 years was 59% and 79%, respectively. In severe elderly (≥ 65 years) TBI patients admitted in ICU, hospital and 6-month mortality was 64.6% and 72.9%, respectively. Beyond mortality, TBI can lead to poor functional neurologic outcome and elderly patients are more prone to survive with disabilities according to a higher rate of comorbidities, frequent use of oral anticoagulants and/or antiplatelet and/or previous brain disorders. In patients hospitalized in ICU, age (> 59 years) was the strongest parameter associated with an unfavorable outcome including death, vegetative state and severe disability, at 6 month. Moreover, TBI elderly patients (≥ 65 years) had worse functional outcome at discharge than younger patients. Identifying elderly patients who may benefit from ICU remained challenging, since there is no consensual guideline of triage. Traumatic brain-injured patients are particularly concerned by this issue. Nevertheless, few data are available related to outcome in elderly TBI patients requiring ICU.
Detailed description
The investigators conducted a multicentre, retrospective, observational study from April 2013 to February 2019 in the surgical ICUs of 5 level 1 Trauma centers in France. The investigators collected data from the "regional intensive care network of the great west of france" (AtlanRéa) database. The AtlanRéa database registers prospectively and consecutively numerous informations about brain injury and trauma patients hospitalized in ICUs, in order to provide epidemiologic informations for this population. Data were collected by clinical research assistants in each participating ICU, using an electronic case report form. The investigators assessed data regarding outcomes after discharge from ICUs through phone interview led by dedicated clinical research assistants.
The following data were entered in the database: Age, gender and body mass index, previous medical history, and more specifically the presence of cardiac insufficiency, chronic renal failure defined as an estimated glomerular filtration rate less than 60 ml/min.1.73 m-1, chronic respiratory illness, neurologic background, diabetes, neoplasia history, previous TBI, active smoking and chronic alcoholism. Mechanism of injury (domestic accident, road traffic crash, fall from heights or others). The Glasgow Coma Score (GCS) score determinates in the prehospital setting or at admission at hospital before intubation and/or sedation, and the presence of at least one nonreactive and dilated pupil at the initial management. Severity of illness according to the Simplified Acute Physiology Score II (SAPS II) the Sequential Organ Failure Assessment (SOFA) score, and the Injury Severity Score (ISS). The investigators also specified the severity of TBI by the abbreviated Injury Score (AIS) and reported the associated injuries from 5 territories (face, chest, abdomen, extremity (including pelvis) and external). Initial CT-scan was classified according to the Marshall classification in six categories (Diffuse injury I, II, III, IV, evacuated mass (V) and non-evacuated mass lesion (VI)).
The following data during the patients' hospitalization are also entered in the database: use of an intracranial pressure (ICP) catheter, occurrence of intracranial hypertension (defined as an ICP above 20 mmHg in absence of confounding factors), and use of barbiturates and/or osmotherapy, decompressive craniectomy, and other neurosurgical procedure. The occurrence of intercurrent events occurring during ICU stay, including infections, Acute Respiratory Distress Syndrome (ARDS), need of vasopressor drugs, acute renal failure, thrombophlebitis, pulmonary embolism, hemorrhage, infection and tracheostomy. The investigators specified the need for intubation and durations of mechanical ventilation, central venous catheterism and vasopressor. The investigators also recorded the decision in ICU to withdraw or withhold life support.
The length of stay in ICU, ICU and 3-month mortalities and patient outcome were assessed using the Glasgow Outcome Scale Extended (GOSE) score at 3 months. The investigators dichotomized the GOSE score between the four lower values (corresponding to unfavorable outcome- GOSE 1 to 4) and the four upper values (corresponding to favorable outcome- GOSE 5 to 8).
Statistical Analysis All statistical analysis will be performed using R software 3.3.1 (package pROC) and SAS 9.1 Statistical Software (SAS Institute, Cary, NC, USA). For quantitative continuous variables, position and dispersion parameters (mean, standard deviation, median, interquartile range) will be calculated. For qualitative variables, proportion rates will be calculated. For groups' comparison, we used independent-samples t-tests for normally distributed continuous variables, and Mann-Whitney U-tests for non-normally distributed continuous variables. Χ² tests will be performed for categorical variables. To build the model for multivariate analysis, the investigators selected among the variables with a p ≤ 0.20 according to the univariate analysis. The investigators performed logistic regression model to identify factors associated with in-ICU mortality and dichotomized GOSE score at 3 months. The Odds Ratios (ORs) and 95% confidence intervals (CI) will be calculated. For continuous variables, diagnosis of log linear behavior was established, and if not confirmed, the variable will be divided into categories and treated as categorical variables. Model's fit will be assessed by checking residual plots and Cook's distance. The calibration of the model will be tested by Goodness of Fit Hosmer-Lemeshow test. A p ≤0.05 will be considered statistically significant for all the comparisons.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traumatic brain injury patients | – | –Traumatic brain injury patients admitted in intensive care unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Traumatic brain injury
Key inclusion criteria (3 listed)
- Traumatic brain injury
- Aged at least 18 years,
- Hospitalized in intensive care unit
Key exclusion criteria (4 listed)
- Patients who die within 24h of hospitalization
- Patients initially resuscitated awaiting for organ donation
- Refusal for study participation expressed by the patient or relatives.
- Missing data related to the main objective of the study (outcome at 3 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Outcome was assessed using the Glasgow Outcome Scale Extended (GOSE) score
Time frame: GOSE score at 3 months.
We dichotomized the GOSE score between the four lower values (corresponding to unfavorable outcome- GOSE 1 to 4) and the four upper values (corresponding to favorable outcome- GOSE 5 to 8).
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 9 Dec 2020.
- Background: PubMed 23443846Roozenbeek B, Maas AI, Menon DK. Changing patterns in the epidemiology of traumatic brain injury. Nat Rev Neurol. 2013 Apr;9(4):231-6. doi: 10.1038/nrneurol.2013.22. Epub 2013 Feb 26.
- Background: PubMed 22220762Stocchetti N, Paterno R, Citerio G, Beretta L, Colombo A. Traumatic brain injury in an aging population. J Neurotrauma. 2012 Apr 10;29(6):1119-25. doi: 10.1089/neu.2011.1995. Epub 2012 Apr 2.
- Background: PubMed 31657946Maiden MJ, Cameron PA, Rosenfeld JV, Cooper DJ, McLellan S, Gabbe BJ. Long-Term Outcomes after Severe Traumatic Brain Injury in Older Adults. A Registry-based Cohort Study. Am J Respir Crit Care Med. 2020 Jan 15;201(2):167-177. doi: 10.1164/rccm.201903-0673OC.
- Background: PubMed 29212411Gardner RC, Dams-O'Connor K, Morrissey MR, Manley GT. Geriatric Traumatic Brain Injury: Epidemiology, Outcomes, Knowledge Gaps, and Future Directions. J Neurotrauma. 2018 Apr 1;35(7):889-906. doi: 10.1089/neu.2017.5371. Epub 2018 Feb 15.
- Background: PubMed 33048909Lim XT, Ang E, Lee ZX, Hajibandeh S, Hajibandeh S. Prognostic significance of preinjury anticoagulation in patients with traumatic brain injury: A systematic review and meta-analysis. J Trauma Acute Care Surg. 2021 Jan 1;90(1):191-201. doi: 10.1097/TA.0000000000002976.
- Background: PubMed 12169925Susman M, DiRusso SM, Sullivan T, Risucci D, Nealon P, Cuff S, Haider A, Benzil D. Traumatic brain injury in the elderly: increased mortality and worse functional outcome at discharge despite lower injury severity. J Trauma. 2002 Aug;53(2):219-23; discussion 223-4. doi: 10.1097/00005373-200208000-00004.
- Background: PubMed 21639728De Bonis P, Pompucci A, Mangiola A, Paternoster G, Festa R, Nucci CG, Maviglia R, Antonelli M, Anile C. Decompressive craniectomy for elderly patients with traumatic brain injury: it's probably not worth the while. J Neurotrauma. 2011 Oct;28(10):2043-8. doi: 10.1089/neu.2011.1889. Epub 2011 Aug 29.
- Background: PubMed 12802167Pettigrew LE, Wilson JT, Teasdale GM. Reliability of ratings on the Glasgow Outcome Scales from in-person and telephone structured interviews. J Head Trauma Rehabil. 2003 May-Jun;18(3):252-8. doi: 10.1097/00001199-200305000-00003.
- Results publication: PubMed 29253420Majdan M, Plancikova D, Brazinova A, Rusnak M, Nieboer D, Feigin V, Maas A. Epidemiology of traumatic brain injuries in Europe: a cross-sectional analysis. Lancet Public Health. 2016 Dec;1(2):e76-e83. doi: 10.1016/S2468-2667(16)30017-2. Epub 2016 Nov 29.
- Derived from this study: PubMed 36585608Launey Y, Coquet A, Lasocki S, Dahyot-Fizelier C, Huet O, Le Pabic E, Roquilly A, Seguin P. Factors associated with an unfavourable outcome in elderly intensive care traumatic brain injury patients. a retrospective multicentre study. BMC Geriatr. 2022 Dec 30;22(1):1004. doi: 10.1186/s12877-022-03651-x.
- Individual participant dataSharing planned: Undecided
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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.
Philippe Seguin, MD, PhD principal investigator
AtlanRéa
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Association pour la Recherche en Aanesthésie Réanimation Digestive.
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 3 inclusion and 4 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 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Outcome was assessed using the Glasgow Outcome Scale Extended (GOSE) score (time frame: GOSE score at 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04651803, which also lists 10 linked publications.
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 9 Dec 2020.