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Impact of Early Optimization of Brain Oxygenation on Neurological Outcome 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 18, 2020
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

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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 Neurological Outcome After Severe Traumatic Brain Injury
Study Start Date : June 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

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. Neurological outcome according to the extended Glasgow Outcome Scale (GOSE) blind assessed [ Time Frame: at 6 months post-trauma ]

Secondary Outcome Measures :
  1. Neurological outcome according to the extended Glasgow Outcome Scale (GOSE) and Disability Rating Scale [ Time Frame: at 12 months post-trauma (GOSE) ]
  2. Disability Rating Scale (DRS) [ Time Frame: at 6 and 12 months post-trauma ]
  3. 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 ]
  4. Mortality rate [ Time Frame: at day 28 ]
  5. 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 ]
  6. 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 ]

Other Outcome Measures:
  1. Ancillary outcome : Volume of cerebral lesions with abnormal MD values, i.e., decreased or increased MD values, using diffusion tensor MR imaging [ Time Frame: at day 6-10 following initiation of cerebral monitoring after severe TBI ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • 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
  • 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:

  • 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
  • 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.

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

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Contact: Marion RICHARD 0033476766729

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Sponsors and Collaborators
University Hospital, Grenoble
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Principal Investigator: Jean-François PAYEN, MD, PhD University Hospital, Grenoble

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Grenoble Identifier: NCT02754063    
Other Study ID Numbers: 38RC14.039
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and 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