CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 320 enrolled
Drug / intervention
PbtO2 probes +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02754063
NCT02754063N/ACompleted

Impact of Early Optimization of Brain Oxygenation on Neurological Outcome After Severe Traumatic Brain Injury

University Hospital, Grenoble·interventional·Posted Apr 28, 2016·Updated May 18, 2022

In Brief

A clinical study evaluating PbtO2 probes and No PbtO2 probes for Brain Injuries, Traumatic. Completed, enrolled 320 participants across 26 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 28, 2016
Enrollment StartJun 1, 2016
Primary CompletionOct 17, 2021
Study CompletionApr 1, 2022
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 10.2 years ago

Interventions

PbtO2 probesdevice

PbtO2/ICP/CPP-directed therapy according to international recommendations

No PbtO2 probesother

ICP/CPP-directed therapy according to international recommendations