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

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ClinicalTrials.gov Identifier: NCT02754063
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):

April 15, 2016
April 28, 2016
March 29, 2017
June 2016
May 2018   (Final data collection date for primary outcome measure)
Volume of cerebral lesions with abnormal mean diffusivity values using diffusion tensor imaging [ Time Frame: 6 to 10 days post TBI ]
Same as current
Complete list of historical versions of study NCT02754063 on ClinicalTrials.gov Archive Site
  • Extended Glasgow Outcome Scale [ Time Frame: 6 and 12 months post TBI ]
  • Functional Independence Measure scale [ Time Frame: 6 and 12 months post TBI ]
  • Short-Form Health Survey with 12 questions (SF-12) [ Time Frame: 6 and 12 months post TBI ]
  • Mortality [ Time Frame: 28 days post TBI ]
  • Therapeutic Intensity Level [ Time Frame: 5 days post TBI ]
  • 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)

  • Extended Glasgow Outcome Scale [ Time Frame: 6 and 12 months post TBI ]
  • Functional Independence Measure scale [ Time Frame: 6 and 12 months post TBI ]
  • Medical Outcomes Study Short-Form 12 [ Time Frame: 6 and 12 months post TBI ]
  • Mortality [ Time Frame: 28 days post TBI ]
  • Therapeutic Intensity Level [ Time Frame: 5 days post TBI ]
  • 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)

Not Provided
Not Provided
 
Impact of Early Optimization of Brain Oxygenation on the Volume of Cerebral Lesions After Severe Traumatic Brain Injury
Impact of Early Optimization of Brain Oxygenation on the Volume of Cerebral Lesions After Severe Traumatic Brain Injury

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Brain Injuries, Traumatic
  • Device: PbtO2 probes
    PbtO2/ICP/CPP-directed therapy according to international recommendations
  • Other: No PbtO2 probes
    ICP/CPP-directed therapy according to international recommendations
  • Active Comparator: ICP Management
    Intervention: Other: No PbtO2 probes
  • Experimental: PbtO2 + ICP Management
    Intervention: Device: PbtO2 probes

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
May 2019
May 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact: Pauline MANHES, PhD 0033476766729 pmanhes@chu-grenoble.fr
France
 
 
NCT02754063
38RC14.039
Yes
Not Provided
Not Provided
University Hospital, Grenoble
University Hospital, Grenoble
Not Provided
Principal Investigator: Jean-François PAYEN, MD, PhD University Hospital, Grenoble
University Hospital, Grenoble
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP