Study Summary
This trial will help doctors determine whether a treatment strategy guided by both intracranial pressure and brain tissue oxygen is more effective than one guided by intracranial pressure alone.
- Traumatic Brain Injury
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 10 Secondary · Reporting Duration: 6 months
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
ICP only
1 of 2
ICP + PbtO2
1 of 2
Active Control
1094 Total Participants · 2 Treatment Groups
Primary Treatment: ICP only · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age Any Age · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.
- Okonkwo, David O., Lori A. Shutter, Carol Moore, Nancy R. Temkin, Ava M. Puccio, Christopher J. Madden, Norberto Andaluz, et al.. 2017. “Brain Oxygen Optimization in Severe Traumatic Brain Injury Phase-ii”. Critical Care Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ccm.0000000000002619.
- Okonkwo, David O., Lori A. Shutter, Carol Moore, Nancy R. Temkin, Ava M. Puccio, Christopher J. Madden, Norberto Andaluz, et al.. 2017. “Brain Oxygen Optimization in Severe Traumatic Brain Injury Phase-ii”. Critical Care Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ccm.0000000000002619.
- Bernard, Francis, William Barsan, Ramon Diaz-Arrastia, Lisa H Merck, Sharon Yeatts, and Lori A Shutter. 2022. “Brain Oxygen Optimization in Severe Traumatic Brain Injury (BOOST-3): A Multicentre, Randomised, Blinded-endpoint, Comparative Effectiveness Study of Brain Tissue Oxygen and Intracranial Pressure Monitoring Versus Intracranial Pressure Alone”. BMJ Open. BMJ. doi:10.1136/bmjopen-2021-060188.
- Fiore M, Bogossian E, Creteur J, Oddo M, Taccone FS. Role of brain tissue oxygenation (PbtO2) in the management of subarachnoid haemorrhage: a scoping review protocol. BMJ Open. 2020 Sep 15;10(9):e035521. doi: 10.1136/bmjopen-2019-035521.
- William Barsan 2019. "Brain Oxygen Optimization in Severe TBI, Phase 3". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03754114.
Frequently Asked Questions
Are there any opportunities still available to take part in this clinical experiment?
"Affirmative. The clinicaltrial.gov database states that this medical experiment, inaugural in late August 2019, is currently enrolling patients. 1094 individuals must be recruited from 35 distinct sites to successfully complete the trial." - Anonymous Online Contributor
How many test subjects are engaged in this experiment?
"As mandated by the inclusion criteria, 1094 willing participants are needed to complete this trial. Patients may sign up at Duke University Hospital in Durham or UPMC Presbyterian Hospital in Pittsburgh." - Anonymous Online Contributor
In what locations is this clinical experiment being conducted?
"The trial is taking place in an array of 35 sites which includes, but not limited to, Durham, Pittsburgh and Houston. For convenience purposes when signing up for the study it is recommended that you locate your nearest clinic to reduce travel time." - Anonymous Online Contributor