Impact of Early Optimization of Brain Oxygenation on the Volume of Cerebral Lesions After Severe Traumatic Brain Injury (OXY-TC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02754063
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : March 29, 2017
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Brain Injuries, Traumatic Device: PbtO2 probes Other: No PbtO2 probes Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Early Optimization of Brain Oxygenation on the Volume of Cerebral Lesions After Severe Traumatic Brain Injury
Study Start Date : June 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: ICP Management Other: No PbtO2 probes
ICP/CPP-directed therapy according to international recommendations
Experimental: PbtO2 + ICP Management Device: PbtO2 probes
PbtO2/ICP/CPP-directed therapy according to international recommendations

Primary Outcome Measures :
  1. Volume of cerebral lesions with abnormal mean diffusivity values using diffusion tensor imaging [ Time Frame: 6 to 10 days post TBI ]

Secondary Outcome Measures :
  1. Extended Glasgow Outcome Scale [ Time Frame: 6 and 12 months post TBI ]
  2. Functional Independence Measure scale [ Time Frame: 6 and 12 months post TBI ]
  3. Short-Form Health Survey with 12 questions (SF-12) [ Time Frame: 6 and 12 months post TBI ]
  4. Mortality [ Time Frame: 28 days post TBI ]
  5. Therapeutic Intensity Level [ Time Frame: 5 days post TBI ]
  6. Number of critical neurological events [ Time Frame: 5 days post TBI ]

    Number of critical events during the first 5 days of the ICU stay 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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Severe non penetrating TBI (initial Glasgow Coma Score 3-8) with motor score between 1 and 5
  • Possible associated extracranial lesions, except tetraplegia
  • Monitoring within the first 16 hours after primary traumatic injury
  • Indication for ICP monitoring on admission as part of the management
  • Indication for continuous sedation/analgesia for more than 48 hours
  • Under mechanical ventilation with stable conditions
  • Affiliation to the French Social Security or affiliated to a social security system of European Union member state, Norway, Lichtenstein, Iceland or Switzerland.
  • French or English-speaking patient

Exclusion Criteria:

  • Penetrating TBI
  • Glasgow Coma Score 3 with bilateral fixed dilated pupils
  • Decompressive craniectomy prior to enrolment
  • Contraindication of ICP and/or PbtO2 monitoring
  • Persistent hemodynamic or respiratory instability
  • Hypothermia <34°C at randomization
  • Venous or arterial lactate concentration >5 mmol/l at randomization
  • Life expectancy < 24 hours
  • Cardiac arrest at initial presentation
  • Tetraplegia
  • Neuropsychiatric co-morbidities that could interfere with 6 and 12-months evaluation
  • Consent refusal
  • Pregnancy
  • Participation to another study with written consent (but observational and genetics study)
  • Inability to have a 6-months follow-up
  • Permanent contraindications to MRI
  • Ischemic stroke after carotid artery dissection
  • Incapacitated patients in accordance with article L 1121-5 to L1121-8 of the public health code.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02754063

Contact: Pauline MANHES, PhD 0033476766729

General Hospital of Annecy Recruiting
Annecy, France
Contact: Samuel GAY, MD         
University Hospital of Bordeaux Not yet recruiting
Bordeaux, France
Contact: Vincent COTTENCEAU, MD         
University Hospital of Clermont-Ferrand Recruiting
Clermont-Ferrand, France
Contact: Russell CHABANNE, MD         
University Hospital of Dijon Not yet recruiting
Dijon, France
Contact: Sébastien MIREK, MD         
Grenoble University Hospital Recruiting
Grenoble, France
Contact: Pierre BOUZAT, MD, PhD         
University Hospital of Kremlin-Bicetre Not yet recruiting
Le Kremlin Bicetre, France
Contact: Bernard VIGUE, MD, PhD         
University Hospital of Lille Not yet recruiting
Lille, France
Contact: Emmanuel VEGA, MD         
University Hospital of Lyon Recruiting
Lyon, France
Contact: Frédéric DAILLER, MD         
University Hospital of Marseille-Nord Not yet recruiting
Marseille, France
Contact: Emmanuelle HAMMAD, MD         
University Hospital of Marseille-Timone Recruiting
Marseille, France
Contact: Nicolas BRUDER, MD, PhD         
University Hospital of Montpellier Recruiting
Montpellier, France
Contact: Frédéric GRECO, MD         
University Hospital of Nancy Recruiting
Nancy, France
Contact: Gérard AUDIBERT, MD, PhD         
University Hospital of Nice Not yet recruiting
Nice, France
Contact: Carole ICHAI, MD, PhD         
University Hospital of Nimes Not yet recruiting
Nimes, France
Contact: Aurélien DAURAT, MD         
University Hospital of Paris-Salpetriere Not yet recruiting
Paris, France
Contact: Lamine ABDENNOUR, MD         
University Hospital of Poitiers Not yet recruiting
Poitiers, France
Contact: Claire DAHYOT-FIZELIER, MD, PhD         
University Hospital of Rennes Recruiting
Rennes, France
Contact: Yoann LAUNEY, MD         
University Hospital of Rouen Recruiting
Rouen, France
Contact: Hélène BRAU, MD         
University Hospital of St-Etienne Recruiting
Saint-Etienne, France
Contact: Laetitia BURNOL, MD         
Hôpital d'Instruction des Armées Recruiting
Toulon, France
Contact: Ambroise MONTCRIOL, MD         
University Hospital of Toulouse Not yet recruiting
Toulouse, France
Contact: Thomas GEERAERTS, MD, PhD         
Sponsors and Collaborators
University Hospital, Grenoble
Principal Investigator: Jean-François PAYEN, MD, PhD University Hospital, Grenoble


Responsible Party: University Hospital, Grenoble Identifier: NCT02754063     History of Changes
Other Study ID Numbers: 38RC14.039
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Brain Injuries, Traumatic
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action