Impact of Early Optimization of Brain Oxygenation on Neurological Outcome After Severe Traumatic Brain Injury
NCT ID: NCT02754063
Last Updated: 2022-05-18
Study Results
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Basic Information
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COMPLETED
NA
320 participants
INTERVENTIONAL
2016-06-30
2022-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ICP Management
No PbtO2 probes
ICP/CPP-directed therapy according to international recommendations
PbtO2 + ICP Management
PbtO2 probes
PbtO2/ICP/CPP-directed therapy according to international recommendations
Interventions
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PbtO2 probes
PbtO2/ICP/CPP-directed therapy according to international recommendations
No PbtO2 probes
ICP/CPP-directed therapy according to international recommendations
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Jean-François PAYEN, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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CHU Angers
Angers, , France
General Hospital of Annecy
Annecy, , France
University Hospital Besançon
Besançon, , France
University Hospital of Bordeaux
Bordeaux, , France
CHU CAEN
Caen, , France
University Hospital of Clermont-Ferrand
Clermont-Ferrand, , France
University Hospital of Dijon
Dijon, , France
Grenoble University Hospital
Grenoble, , France
University Hospital of Kremlin-Bicetre
Le Kremlin-Bicêtre, , France
University Hospital of Lille
Lille, , France
University Hospital of Lyon
Lyon, , France
University Hospital of Marseille-Nord
Marseille, , France
University Hospital of Marseille-Timone
Marseille, , France
University Hospital of Montpellier
Montpellier, , France
University Hospital of Nancy
Nancy, , France
University Hospital of Nice
Nice, , France
University Hospital of Nimes
Nîmes, , France
University Hospital of Paris-Salpetriere
Paris, , France
University Hospital of Poitiers
Poitiers, , France
University Hospital of Rennes
Rennes, , France
University Hospital of Rouen
Rouen, , France
University Hospital of St-Etienne
Saint-Etienne, , France
University Hospital Sud Réunion
Saint-Pierre, , France
University Hospital of Strasbourg
Strasbourg, , France
Hôpital d'Instruction des Armées
Toulon, , France
University Hospital of Toulouse
Toulouse, , France
Countries
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References
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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.
Brain 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.
Oddo 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.
van 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.
Stiefel 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.
Narotam 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.
Payen 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.
Payen 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.
Mistral 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.
Payen 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.
Other Identifiers
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38RC14.039
Identifier Type: -
Identifier Source: org_study_id
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