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Trial record 5 of 311 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

Impact of Early Optimization of Brain Oxygenation on Neurological Outcome 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 : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

April 15, 2016
April 28, 2016
April 24, 2018
June 2016
December 2019   (Final data collection date for primary outcome measure)
Neurological outcome according to the extended Glasgow Outcome Scale (GOSE) blind assessed [ Time Frame: at 6 months post-trauma ]
Volume of cerebral lesions with abnormal mean diffusivity values using diffusion tensor imaging [ Time Frame: 6 to 10 days post TBI ]
Complete list of historical versions of study NCT02754063 on ClinicalTrials.gov Archive Site
  • Neurological outcome according to the extended Glasgow Outcome Scale (GOSE) and Disability Rating Scale [ Time Frame: at 12 months post-trauma (GOSE) ]
  • Disability Rating Scale (DRS) [ Time Frame: at 6 and 12 months post-trauma ]
  • 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 ]
  • Mortality rate [ Time Frame: at day 28 ]
  • 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 ]
  • 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 ]
  • 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)

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 ]
Not Provided
 
Impact of Early Optimization of Brain Oxygenation on Neurological Outcome After Severe Traumatic Brain Injury
Impact of Early Optimization of Brain Oxygenation on Neurological Outcome 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 Applicable
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
Same as current
December 2020
December 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact: Marion RICHARD 0033476766729 MRichard7@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
April 2018

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