{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T08:23:30Z","timestamp":1773303810486,"version":"3.50.1"},"reference-count":31,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2020,8,20]],"date-time":"2020-08-20T00:00:00Z","timestamp":1597881600000},"content-version":"unspecified","delay-in-days":19,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"French National Program for Clinical Research","award":["RCB 2014-A01674-43"],"award-info":[{"award-number":["RCB 2014-A01674-43"]}]},{"name":"Integra Lifesciences","award":["38RC14.039"],"award-info":[{"award-number":["38RC14.039"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2020,7,16]]},"published-print":{"date-parts":[[2020,8]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Intracranial hypertension is considered as an independent risk factor of mortality and neurological disabilities after severe traumatic brain injury (TBI). However, clinical studies have demonstrated that episodes of brain ischaemia\/hypoxia are common despite normalisation of intracranial pressure (ICP). This study assesses the impact on neurological outcome of guiding therapeutic strategies based on the monitoring of both brain tissue oxygenation pressure (PbtO<jats:sub>2<\/jats:sub>) and ICP during the first 5 days following severe TBI.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>Multicentre, open-labelled, randomised controlled superiority trial with two parallel groups in 300 patients with severe TBI. Intracerebral monitoring must be in place within the first 16\u2009hours post-trauma. Patients are randomly assigned to the ICP group or to the ICP + PbtO<jats:sub>2<\/jats:sub> group. The ICP group is managed according to the international guidelines to maintain ICP\u226420\u2009mm Hg. The ICP + PbtO<jats:sub>2<\/jats:sub> group is managed to maintain PbtO<jats:sub>2<\/jats:sub> \u226520\u2009mm Hg in addition to the conventional optimisation of ICP. The primary outcome measure is the neurological status at 6 months as assessed using the extended Glasgow Outcome Scale. Secondary outcome measures include quality-of-life assessment, mortality rate, therapeutic intensity and incidence of critical events during the first 5 days. Analysis will be performed according to the intention-to-treat principle and full statistical analysis plan developed prior to database freeze.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>This study has been approved by the Institutional Review Board of Sud-Est V (14-CHUG-48) and from the National Agency for Medicines and Health Products Safety (Agence Nationale de S\u00e9curit\u00e9 du M\u00e9dicament et des produits de sant\u00e9) (141\u2009435B-31). Results will be presented at scientific meetings and published in peer-reviewed publications.The study was registered with ClinTrials <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT02754063\">NCT02754063<\/jats:ext-link> on 28 April 2016 (pre-results).<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-040550","type":"journal-article","created":{"date-parts":[[2020,8,21]],"date-time":"2020-08-21T07:26:19Z","timestamp":1597994779000},"page":"e040550","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":27,"title":["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"],"prefix":"10.1136","volume":"10","clinical-trial-number":[{"clinical-trial-number":"nct02754063","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03754114","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8400-3839","authenticated-orcid":false,"given":"Jean-Francois","family":"Payen","sequence":"first","affiliation":[{"name":"Department of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, INSERM, U1216, Grenoble, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marion","family":"Richard","sequence":"additional","affiliation":[{"name":"Department of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, INSERM, U1216, Grenoble, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gilles","family":"Francony","sequence":"additional","affiliation":[{"name":"Department of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, INSERM, U1216, Grenoble, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G\u00e9rard","family":"Audibert","sequence":"additional","affiliation":[{"name":"Department of Anaesthesia and Intensive Care, Lorraine University, Nancy University Hospital, Nancy, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emmanuel L","family":"Barbier","sequence":"additional","affiliation":[{"name":"Department of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, INSERM, U1216, Grenoble, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicolas","family":"Bruder","sequence":"additional","affiliation":[{"name":"Department of Anaesthesiology and Intensive Care, Aix-Marseille University, Assistance Publique - H\u00f4pitaux de Marseille, Marseille, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claire","family":"Dahyot-Fizelier","sequence":"additional","affiliation":[{"name":"Department of Anaesthesia and Intensive Care, Poitiers University Hospital and Poitiers Hospital, Pharmacology of antimicrobial agents, INSERM U1070, Poitiers, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Geeraerts","sequence":"additional","affiliation":[{"name":"Department of Anaesthesia and Intensive Care, Toulouse University Hospital and Toulouse 3-Paul Sabatier University, Toulouse, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laurent","family":"Gergele","sequence":"additional","affiliation":[{"name":"Department of Intensive care, Ramsay Sante, Hopital Priv\u00e9 de la Loire, Saint-Etienne, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Louis","family":"Puybasset","sequence":"additional","affiliation":[{"name":"Department of Anaesthesia and Critical Care, Sorbonne University, GRC 29, AP-HP, DMU DREAM, Piti\u00e9-Salp\u00eatri\u00e8re Hospital, Paris, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bernard","family":"Vigue","sequence":"additional","affiliation":[{"name":"Department of Anaesthesia and Intensive care, Centre Hospitalier Universitaire de Bic\u00eatre, Assistance Publique - Hopitaux de Paris, Le Kremlin Bic\u00eatre, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kristina","family":"Skaare","sequence":"additional","affiliation":[{"name":"Department of Public Health, Univ. 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