Brain Injuries, TraumaticOXY-TCNCT02754063
Impact of Early Optimization of Brain Oxygenation on Neurological Outcome After Severe Traumatic Brain Injury
A study testing PbtO2 probes and No PbtO2 probes in people with Brain Injuries, Traumatic, run by University Hospital, Grenoble at 26 sites in France.
Trial summary
Post-traumatic brain hypoxia/ischemia develops hours after traumatic brain injury (TBI), and its intensity is directly related to the neurological outcome. The thresholds for irreversible tissue damage following TBI indicate a particular vulnerability of injured brain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- PbtO2 probes and No PbtO2 probes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 26 sitesFrance
- Study dates
- Jun 2016to Apr 2022
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75
- Severe non- penetrating TBI (GCS score 3-8) with motor Glasgow score between 1 and 5
- Possible associated extracranial lesions, except tetraplegia
- Initiation of cerebral monitoring within the first 16 hours since primary traumaticinjury
- Indication of ICP monitoring on admission as part of the management
- Indication of continuous sedation/analgesia for more than 48 hours
Show all 10Show fewer
- Under mechanical ventilation with stable conditions: PaO2//FiO2 over 150 and PaCO2 between 35 and 45 mmHg, mean arterial pressure over 70 mmHg
- Written informed consent from legal surrogate, patient's relative or investigator decision
- Affiliation to the French Social Security or affiliated to a social security system of EU member state, Norway, Lichtenstein, Iceland or Switzerland
- French-speaking or English-speaking patient
Who cannot join
- Penetrating TBI
- GCS 3 with bilateral fixed dilated pupils
- Decompressive craniectomy and no repositioning of the bone flap after subdural hematoma evacuation surgery prior to enrolment
- Contraindication of ICP and/or PbtO2 monitoring, i.e., hemostasis disorders and brain tissue infection
- Persistent hemodynamic or respiratory instability despite treatments, i.e., mean arterial pressure < 70 mmHg, PaO2/FiO2 <150, PaCO2 <30 mmHg or >45 mmHg or lactate >5 mmol/l if available.
- Hypothermia <34°C at randomization
Show all 16Show fewer
- Life expectancy < 24 hours
- Cardiac arrest at initial presentation
- Tetraplegia
- Neuropsychiatric co-morbidities that could interfere with 6 and 12-months assessment outcomes.
- Consent refusal
- Pregnancy
- Participation in another therapeutic study with written consent
- Inability to have a 6-months follow-up
- Ischemic stroke after carotid arterial dissection
- Incapacitated patients in accordance with article L 1121-5 to L1121-8 of the public health code.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
France26 sites
CHU Angers
Angers
General Hospital of Annecy
Annecy
University Hospital Besançon
Besançon
University Hospital of Bordeaux
Bordeaux
CHU CAEN
Caen
University Hospital of Clermont-Ferrand
Clermont-Ferrand
University Hospital of Dijon
Dijon
Grenoble University Hospital
Grenoble
University Hospital of Kremlin-Bicetre
Le Kremlin-Bicêtre
University Hospital of Lille
Lille
University Hospital of Lyon
Lyon
University Hospital of Marseille-Nord
Marseille
University Hospital of Marseille-Timone
Marseille
University Hospital of Montpellier
Montpellier
University Hospital of Nancy
Nancy
University Hospital of Nice
Nice
University Hospital of Nimes
Nîmes
University Hospital of Paris-Salpetriere
Paris
University Hospital of Poitiers
Poitiers
University Hospital of Rennes
Rennes
University Hospital of Rouen
Rouen
University Hospital of St-Etienne
Saint-Etienne
University Hospital Sud Réunion
Saint-Pierre
University Hospital of Strasbourg
Strasbourg
Hôpital d'Instruction des Armées
Toulon
University Hospital of Toulouse
Toulouse
About this study
Post-traumatic brain hypoxia/ischemia develops hours after traumatic brain injury (TBI), and its intensity is directly related to the neurological outcome. The thresholds for irreversible tissue damage following TBI indicate a particular vulnerability of injured brain. Improving brain oxygenation after severe TBI is the focus of modern TBI management in the intensive care unit (ICU).
The calculation of cerebral perfusion pressure (CPP), with CPP = mean arterial pressure (MAP) - intracranial pressure (ICP), has become the most used estimator of cerebral blow flow. To prevent ischemia due to elevated ICP, current international guidelines recommend maintaining CPP at 60-70 mmHg and ICP below 20 mmHg. However, episodes of brain hypoxia/ischemia, as assessed with brain tissue oxygen pressure (PbtO2) measurements, might occur despite optimization of CPP and ICP, and have been independently associated with poorer patient outcome. PbtO2 values lower than 15 mmHg for more than 30 minutes were shown to be an independent predictor of unfavorable outcome and death. The aggressive treatment of low PbtO2 was associated with improved outcome compared to standard ICP/CPP-directed therapy in cohort studies of severely head-injured patients. On the basis of these findings, it is hypothesized that an early optimization of brain oxygenation, together with keeping ICP and CPP within recommended values, could reduce the volume of vulnerable lesions following severe TBI and possibly improve neurological outcome.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- PbtO2 probes, No PbtO2 probes
- 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.
PbtO2 probesDevice
PbtO2/ICP/CPP-directed therapy according to international recommendations
No PbtO2 probesOther
ICP/CPP-directed therapy according to international recommendations
| Study group | Role | What they receive |
|---|---|---|
| ICP Management | Active comparator | Not described Receives: Other: No PbtO2 probes |
| PbtO2 + ICP Management | Experimental | Not described Receives: Device: PbtO2 probes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological outcome according to the extended Glasgow Outcome Scale (GOSE) blind assessed
Measured: at 6 months post-trauma
Secondary outcomes (6)
Neurological outcome according to the extended Glasgow Outcome Scale (GOSE) and Disability Rating Scale
Measured: at 12 months post-trauma (GOSE)
Disability Rating Scale (DRS)
Measured: at 6 and 12 months post-trauma
Quality of life assessment: Functional Independence Measure (FIM) and Medical Outcomes Study Short-Form 12 (SF-12)
Measured: at 6 and 12 months post-trauma
Mortality rate
Measured: at day 28
Therapeutic intensity as reflected by the number of level 2 and level 3 treatments to treat elevated ICP
Measured: during the first 5 days of the ICU stay
Incidence of critical events as defined by: ICP >30 mmHg during 30 min at least ICP >40 mmHg during 5 min at least PbtO2 <10 mmHg during 30 min at least (PbtO2 group)
Measured: during the first 5 days of the ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startJun 2016
- Primary completion17 Oct 2021
- Study completionApr 2022
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 Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François PAYEN, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754063
- Sponsor's protocol ID
- 38RC14.039
- Acronym
- OXY-TC
- Status last verified
- May 2022
- First submitted
- 15 Apr 2016
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cunningham AS, Salvador R, Coles JP, Chatfield DA, Bradley PG, Johnston AJ, Steiner LA, Fryer TD, Aigbirhio FI, Smielewski P, Williams GB, Carpenter TA, Gillard JH, Pickard JD, Menon DK. Physiological thresholds for irreversible tissue damage in contusional regions following traumatic brain injury. Brain. 2005 Aug;128(Pt 8):1931-42. doi: 10.1093/brain/awh536. Epub 2005 May 11.
PubMed 15888537Brain Trauma Foundation; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Joint Section on Neurotrauma and Critical Care, AANS/CNS; Bratton SL, Chestnut RM, Ghajar J, McConnell Hammond FF, Harris OA, Hartl R, Manley GT, Nemecek A, Newell DW, Rosenthal G, Schouten J, Shutter L, Timmons SD, Ullman JS, Videtta W, Wilberger JE, Wright DW. Guidelines for the management of severe traumatic brain injury. IX. Cerebral perfusion thresholds. J Neurotrauma. 2007;24 Suppl 1:S59-64. doi: 10.1089/neu.2007.9987. No abstract available.
PubMed 17511547Oddo M, Levine JM, Mackenzie L, Frangos S, Feihl F, Kasner SE, Katsnelson M, Pukenas B, Macmurtrie E, Maloney-Wilensky E, Kofke WA, LeRoux PD. Brain hypoxia is associated with short-term outcome after severe traumatic brain injury independently of intracranial hypertension and low cerebral perfusion pressure. Neurosurgery. 2011 Nov;69(5):1037-45; discussion 1045. doi: 10.1227/NEU.0b013e3182287ca7.
PubMed 21673608van den Brink WA, van Santbrink H, Steyerberg EW, Avezaat CJ, Suazo JA, Hogesteeger C, Jansen WJ, Kloos LM, Vermeulen J, Maas AI. Brain oxygen tension in severe head injury. Neurosurgery. 2000 Apr;46(4):868-76; discussion 876-8. doi: 10.1097/00006123-200004000-00018.
PubMed 10764260Stiefel MF, Spiotta A, Gracias VH, Garuffe AM, Guillamondegui O, Maloney-Wilensky E, Bloom S, Grady MS, LeRoux PD. Reduced mortality rate in patients with severe traumatic brain injury treated with brain tissue oxygen monitoring. J Neurosurg. 2005 Nov;103(5):805-11. doi: 10.3171/jns.2005.103.5.0805.
PubMed 16304983Narotam PK, Morrison JF, Nathoo N. Brain tissue oxygen monitoring in traumatic brain injury and major trauma: outcome analysis of a brain tissue oxygen-directed therapy. J Neurosurg. 2009 Oct;111(4):672-82. doi: 10.3171/2009.4.JNS081150.
PubMed 19463048Payen JF, Vilotitch A, Gauss T, Adolle A, Bosson JL, Bouzat P; OXY-TC trial collaborators. Sex Differences in Neurological Outcome at 6 and 12 Months Following Severe Traumatic Brain Injury. An Observational Analysis of the OXY-TC Trial. J Neurotrauma. 2025 Jun;42(11-12):974-984. doi: 10.1089/neu.2024.0390. Epub 2025 Jan 23.
PubMed 39846855Payen JF, Launey Y, Chabanne R, Gay S, Francony G, Gergele L, Vega E, Montcriol A, Couret D, Cottenceau V, Pili-Floury S, Gakuba C, Hammad E, Audibert G, Pottecher J, Dahyot-Fizelier C, Abdennour L, Gauss T, Richard M, Vilotitch A, Bosson JL, Bouzat P; OXY-TC trial collaborators. Intracranial pressure monitoring with and without brain tissue oxygen pressure monitoring for severe traumatic brain injury in France (OXY-TC): an open-label, randomised controlled superiority trial. Lancet Neurol. 2023 Nov;22(11):1005-1014. doi: 10.1016/S1474-4422(23)00290-9.
PubMed 37863590Mistral T, Roca P, Maggia C, Tucholka A, Forbes F, Doyle S, Krainik A, Galanaud D, Schmitt E, Kremer S, Kastler A, Tropres I, Barbier EL, Payen JF, Dojat M. Automated Quantification of Brain Lesion Volume From Post-trauma MR Diffusion-Weighted Images. Front Neurol. 2022 Feb 23;12:740603. doi: 10.3389/fneur.2021.740603. eCollection 2021.
PubMed 35281992Payen JF, Richard M, Francony G, Audibert G, Barbier EL, Bruder N, Dahyot-Fizelier C, Geeraerts T, Gergele L, Puybasset L, Vigue B, Skaare K, Bosson JL, Bouzat P. Comparison of strategies for monitoring and treating patients at the early phase of severe traumatic brain injury: the multicentre randomised controlled OXY-TC trial study protocol. BMJ Open. 2020 Aug 20;10(8):e040550. doi: 10.1136/bmjopen-2020-040550.
PubMed 32820002
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Optimization of Brain Oxygenation on Neurological Outcome After Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02754063
- Acronym / sponsor ID
- OXY-TC / 38RC14.039
- Conditions
- Brain Injuries, Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- 17 Oct 2021 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 28 Apr 2016 (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.
Post-traumatic brain hypoxia/ischemia develops hours after traumatic brain injury (TBI), and its intensity is directly related to the neurological outcome. The thresholds for irreversible tissue damage following TBI indicate a particular vulnerability of injured brain. Improving brain oxygenation after severe TBI is the focus of modern TBI management in the intensive care unit (ICU).
The calculation of cerebral perfusion pressure (CPP), with CPP = mean arterial pressure (MAP) - intracranial pressure (ICP), has become the most used estimator of cerebral blow flow. To prevent ischemia due to elevated ICP, current international guidelines recommend maintaining CPP at 60-70 mmHg and ICP below 20 mmHg. However, episodes of brain hypoxia/ischemia, as assessed with brain tissue oxygen pressure (PbtO2) measurements, might occur despite optimization of CPP and ICP, and have been independently associated with poorer patient outcome. PbtO2 values lower than 15 mmHg for more than 30 minutes were shown to be an independent predictor of unfavorable outcome and death. The aggressive treatment of low PbtO2 was associated with improved outcome compared to standard ICP/CPP-directed therapy in cohort studies of severely head-injured patients. On the basis of these findings, it is hypothesized that an early optimization of brain oxygenation, together with keeping ICP and CPP within recommended values, could reduce the volume of vulnerable lesions following severe TBI and possibly improve neurological outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICP Management | Active comparator | Other: No PbtO2 probes |
| PbtO2 + ICP Management | Experimental | Device: PbtO2 probes |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age between 18 and 75
- Severe non- penetrating TBI (GCS score 3-8) with motor Glasgow score between 1 and 5
- Possible associated extracranial lesions, except tetraplegia
- Initiation of cerebral monitoring within the first 16 hours since primary traumaticinjury
- Indication of ICP monitoring on admission as part of the management
Key exclusion criteria (16 listed)
- Penetrating TBI
- GCS 3 with bilateral fixed dilated pupils
- Decompressive craniectomy and no repositioning of the bone flap after subdural hematoma evacuation surgery prior to enrolment
- Contraindication of ICP and/or PbtO2 monitoring, i.e., hemostasis disorders and brain tissue infection
- Persistent hemodynamic or respiratory instability despite treatments, i.e., mean arterial pressure < 70 mmHg, PaO2/FiO2 <150, PaCO2 <30 mmHg or >45 mmHg or lactate >5 mmol/l if available.
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 |
|---|---|---|
| PbtO2 probesPbtO2/ICP/CPP-directed therapy according to international recommendations | Device | PbtO2 + ICP Management |
| No PbtO2 probesICP/CPP-directed therapy according to international recommendations | Other | ICP Management |
Primary outcome
Neurological outcome according to the extended Glasgow Outcome Scale (GOSE) blind assessed
Time frame: at 6 months post-trauma
6 secondary outcomes
Neurological outcome according to the extended Glasgow Outcome Scale (GOSE) and Disability Rating Scale
Time frame: at 12 months post-trauma (GOSE)
Disability Rating Scale (DRS)
Time frame: at 6 and 12 months post-trauma
Quality of life assessment: Functional Independence Measure (FIM) and Medical Outcomes Study Short-Form 12 (SF-12)
Time frame: at 6 and 12 months post-trauma
Mortality rate
Time frame: at day 28
Therapeutic intensity as reflected by the number of level 2 and level 3 treatments to treat elevated ICP
Time frame: during the first 5 days of the ICU stay
Incidence of critical events as defined by: ICP >30 mmHg during 30 min at least ICP >40 mmHg during 5 min at least PbtO2 <10 mmHg during 30 min at least (PbtO2 group)
Time frame: during the first 5 days of the ICU stay
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 18 May 2022.
- Background: PubMed 15888537Cunningham AS, Salvador R, Coles JP, Chatfield DA, Bradley PG, Johnston AJ, Steiner LA, Fryer TD, Aigbirhio FI, Smielewski P, Williams GB, Carpenter TA, Gillard JH, Pickard JD, Menon DK. Physiological thresholds for irreversible tissue damage in contusional regions following traumatic brain injury. Brain. 2005 Aug;128(Pt 8):1931-42. doi: 10.1093/brain/awh536. Epub 2005 May 11.
- Background: PubMed 17511547Brain Trauma Foundation; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Joint Section on Neurotrauma and Critical Care, AANS/CNS; Bratton SL, Chestnut RM, Ghajar J, McConnell Hammond FF, Harris OA, Hartl R, Manley GT, Nemecek A, Newell DW, Rosenthal G, Schouten J, Shutter L, Timmons SD, Ullman JS, Videtta W, Wilberger JE, Wright DW. Guidelines for the management of severe traumatic brain injury. IX. Cerebral perfusion thresholds. J Neurotrauma. 2007;24 Suppl 1:S59-64. doi: 10.1089/neu.2007.9987. No abstract available.
- Background: PubMed 21673608Oddo M, Levine JM, Mackenzie L, Frangos S, Feihl F, Kasner SE, Katsnelson M, Pukenas B, Macmurtrie E, Maloney-Wilensky E, Kofke WA, LeRoux PD. Brain hypoxia is associated with short-term outcome after severe traumatic brain injury independently of intracranial hypertension and low cerebral perfusion pressure. Neurosurgery. 2011 Nov;69(5):1037-45; discussion 1045. doi: 10.1227/NEU.0b013e3182287ca7.
- Background: PubMed 10764260van den Brink WA, van Santbrink H, Steyerberg EW, Avezaat CJ, Suazo JA, Hogesteeger C, Jansen WJ, Kloos LM, Vermeulen J, Maas AI. Brain oxygen tension in severe head injury. Neurosurgery. 2000 Apr;46(4):868-76; discussion 876-8. doi: 10.1097/00006123-200004000-00018.
- Background: PubMed 16304983Stiefel MF, Spiotta A, Gracias VH, Garuffe AM, Guillamondegui O, Maloney-Wilensky E, Bloom S, Grady MS, LeRoux PD. Reduced mortality rate in patients with severe traumatic brain injury treated with brain tissue oxygen monitoring. J Neurosurg. 2005 Nov;103(5):805-11. doi: 10.3171/jns.2005.103.5.0805.
- Background: PubMed 19463048Narotam PK, Morrison JF, Nathoo N. Brain tissue oxygen monitoring in traumatic brain injury and major trauma: outcome analysis of a brain tissue oxygen-directed therapy. J Neurosurg. 2009 Oct;111(4):672-82. doi: 10.3171/2009.4.JNS081150.
- Derived from this study: PubMed 39846855Payen JF, Vilotitch A, Gauss T, Adolle A, Bosson JL, Bouzat P; OXY-TC trial collaborators. Sex Differences in Neurological Outcome at 6 and 12 Months Following Severe Traumatic Brain Injury. An Observational Analysis of the OXY-TC Trial. J Neurotrauma. 2025 Jun;42(11-12):974-984. doi: 10.1089/neu.2024.0390. Epub 2025 Jan 23.
- Derived from this study: PubMed 37863590Payen JF, Launey Y, Chabanne R, Gay S, Francony G, Gergele L, Vega E, Montcriol A, Couret D, Cottenceau V, Pili-Floury S, Gakuba C, Hammad E, Audibert G, Pottecher J, Dahyot-Fizelier C, Abdennour L, Gauss T, Richard M, Vilotitch A, Bosson JL, Bouzat P; OXY-TC trial collaborators. Intracranial pressure monitoring with and without brain tissue oxygen pressure monitoring for severe traumatic brain injury in France (OXY-TC): an open-label, randomised controlled superiority trial. Lancet Neurol. 2023 Nov;22(11):1005-1014. doi: 10.1016/S1474-4422(23)00290-9.
- Derived from this study: PubMed 35281992Mistral T, Roca P, Maggia C, Tucholka A, Forbes F, Doyle S, Krainik A, Galanaud D, Schmitt E, Kremer S, Kastler A, Tropres I, Barbier EL, Payen JF, Dojat M. Automated Quantification of Brain Lesion Volume From Post-trauma MR Diffusion-Weighted Images. Front Neurol. 2022 Feb 23;12:740603. doi: 10.3389/fneur.2021.740603. eCollection 2021.
- Derived from this study: PubMed 32820002Payen JF, Richard M, Francony G, Audibert G, Barbier EL, Bruder N, Dahyot-Fizelier C, Geeraerts T, Gergele L, Puybasset L, Vigue B, Skaare K, Bosson JL, Bouzat P. Comparison of strategies for monitoring and treating patients at the early phase of severe traumatic brain injury: the multicentre randomised controlled OXY-TC trial study protocol. BMJ Open. 2020 Aug 20;10(8):e040550. doi: 10.1136/bmjopen-2020-040550.
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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.
Jean-François PAYEN, MD, PhD principal investigator
University Hospital, Grenoble
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PbtO2 probes and No PbtO2 probes in people with Brain Injuries, Traumatic, run by University Hospital, Grenoble at 26 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 10 inclusion and 16 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 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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?
Neurological outcome according to the extended Glasgow Outcome Scale (GOSE) blind assessed (time frame: at 6 months post-trauma). 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 NCT02754063, 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 18 May 2022.