Traumatic Brain InjuryNCT01077089
Effects of Transport on Patients With Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by University of Cincinnati at 1 site in United States.
Trial summary
Hospitalized patients are often moved from their rooms to other hospital locations, particularly imaging facilities. For patients with traumatic brain injury, such movements may raise the risk of secondary brain injuries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with traumatic brain injury
Who may be able to join
- presence of traumatic brain injury and intracranial pressure monitoring
- requiring mechanical ventilation
- presence of an indwelling arterial catheter for monitoring blood pressure
- Age of at least 18 years
Who cannot join
- Age less than 18 years
- diagnosis of brain death
- non-English speakers
- prisoners
- mentally ill persons
Trial locations and contacts
1 site in 1 country.
About this study
Hospitalized patients are often moved from their rooms to other hospital locations, particularly imaging facilities. For patients with traumatic brain injury, such movements may raise the risk of secondary brain injuries. The purpose of this study is to monitor brain injured patients during transport and to measure the resulting changes in intracranial pressure. This will allow for documentation of the frequency of secondary injury and help in understanding their causes.
Read the detailed description
Secondary insults, such as hypoxia and hypotension, may worsen a brain injury. We hypothesize that secondary brain insults may occur frequently during in-hospital transport in patients with traumatic brain injury (TBI). We additionally hypothesize that automated data collection devices used during transport could more reliably document the frequency of these events and help us to understand the causes. During transport of patients with TBI, intracranial pressure and arterial blood pressure will be continuously recorded to a monitor and saved for later analysis. Additional continuous measurements of pulse oximetry, end-tidal carbon dioxide, and mechanical ventilation settings will be made. The study will identify patients at risk for secondary insults, the etiology of these insults, and assist in development of a road map to prevent future incidents.
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury, In-hospital transport
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transported TBI patients | Traumatically brain injured patients undergoing in-hospital transport. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events during transport.
Measured: Each transport event
Secondary outcomes (7)
Incidence of elevated heart rate during transport.
Measured: Each transport event
Incidence of transport events during which SpO2 remains below 90% for 1 minute or longer
Measured: Each transport event
Transport events during which systolic blood pressure remains below 90 mmHg for 5 minutes or longer
Measured: Each transport event
Transport events during which mean arterial blood pressure remains below 60 mmHg for 5 minutes or longer
Measured: Each transport event
Transport events during which intracranial pressure exceeds 20 mmHg for 5 minutes or longer
Measured: Each transport event
Transport events during which cerebral perfusion pressure remains below 70 mmHg for 5 minutes or longer
Measured: Each transport event
Number of instances of physiological change that require caregiver intervention, such as ventilator manipulation or drug therapy
Measured: Each transport event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Rich Branson, M.D., University of Cincinnati
- Investigators
- Warren A Dorlac, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077089
- Sponsor's protocol ID
- Dorlac-2010-01
- Status last verified
- Feb 2013
- First submitted
- 25 Feb 2010
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Chesnut RM, Marshall LF, Klauber MR, Blunt BA, Baldwin N, Eisenberg HM, Jane JA, Marmarou A, Foulkes MA. The role of secondary brain injury in determining outcome from severe head injury. J Trauma. 1993 Feb;34(2):216-22. doi: 10.1097/00005373-199302000-00006.
PubMed 8459458Chesnut RM, Marshall SB, Piek J, Blunt BA, Klauber MR, Marshall LF. Early and late systemic hypotension as a frequent and fundamental source of cerebral ischemia following severe brain injury in the Traumatic Coma Data Bank. Acta Neurochir Suppl (Wien). 1993;59:121-5. doi: 10.1007/978-3-7091-9302-0_21.
PubMed 8310858Jeremitsky E, Omert L, Dunham CM, Protetch J, Rodriguez A. Harbingers of poor outcome the day after severe brain injury: hypothermia, hypoxia, and hypoperfusion. J Trauma. 2003 Feb;54(2):312-9. doi: 10.1097/01.TA.0000037876.37236.D6.
PubMed 12579057Manley G, Knudson MM, Morabito D, Damron S, Erickson V, Pitts L. Hypotension, hypoxia, and head injury: frequency, duration, and consequences. Arch Surg. 2001 Oct;136(10):1118-23. doi: 10.1001/archsurg.136.10.1118.
PubMed 11585502
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transport on Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01077089
- Acronym / sponsor ID
- Dorlac-2010-01
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury, In-hospital transport
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Feb 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 26 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hospitalized patients are often moved from their rooms to other hospital locations, particularly imaging facilities. For patients with traumatic brain injury, such movements may raise the risk of secondary brain injuries. The purpose of this study is to monitor brain injured patients during transport and to measure the resulting changes in intracranial pressure. This will allow for documentation of the frequency of secondary injury and help in understanding their causes.
Detailed description
Secondary insults, such as hypoxia and hypotension, may worsen a brain injury. We hypothesize that secondary brain insults may occur frequently during in-hospital transport in patients with traumatic brain injury (TBI). We additionally hypothesize that automated data collection devices used during transport could more reliably document the frequency of these events and help us to understand the causes. During transport of patients with TBI, intracranial pressure and arterial blood pressure will be continuously recorded to a monitor and saved for later analysis. Additional continuous measurements of pulse oximetry, end-tidal carbon dioxide, and mechanical ventilation settings will be made. The study will identify patients at risk for secondary insults, the etiology of these insults, and assist in development of a road map to prevent future incidents.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transported TBI patients | – | –Traumatically brain injured patients undergoing in-hospital transport. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with traumatic brain injury
Key inclusion criteria (4 listed)
- presence of traumatic brain injury and intracranial pressure monitoring
- requiring mechanical ventilation
- presence of an indwelling arterial catheter for monitoring blood pressure
- Age of at least 18 years
Key exclusion criteria (5 listed)
- Age less than 18 years
- diagnosis of brain death
- non-English speakers
- prisoners
- mentally ill persons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of adverse events during transport.
Time frame: Each transport event
7 secondary outcomes
Incidence of elevated heart rate during transport.
Time frame: Each transport event
Incidence of transport events during which SpO2 remains below 90% for 1 minute or longer
Time frame: Each transport event
Transport events during which systolic blood pressure remains below 90 mmHg for 5 minutes or longer
Time frame: Each transport event
Transport events during which mean arterial blood pressure remains below 60 mmHg for 5 minutes or longer
Time frame: Each transport event
Transport events during which intracranial pressure exceeds 20 mmHg for 5 minutes or longer
Time frame: Each transport event
Transport events during which cerebral perfusion pressure remains below 70 mmHg for 5 minutes or longer
Time frame: Each transport event
Number of instances of physiological change that require caregiver intervention, such as ventilator manipulation or drug therapy
Time frame: Each transport event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
- Background: PubMed 8459458Chesnut RM, Marshall LF, Klauber MR, Blunt BA, Baldwin N, Eisenberg HM, Jane JA, Marmarou A, Foulkes MA. The role of secondary brain injury in determining outcome from severe head injury. J Trauma. 1993 Feb;34(2):216-22. doi: 10.1097/00005373-199302000-00006.
- Background: PubMed 8310858Chesnut RM, Marshall SB, Piek J, Blunt BA, Klauber MR, Marshall LF. Early and late systemic hypotension as a frequent and fundamental source of cerebral ischemia following severe brain injury in the Traumatic Coma Data Bank. Acta Neurochir Suppl (Wien). 1993;59:121-5. doi: 10.1007/978-3-7091-9302-0_21.
- Background: PubMed 12579057Jeremitsky E, Omert L, Dunham CM, Protetch J, Rodriguez A. Harbingers of poor outcome the day after severe brain injury: hypothermia, hypoxia, and hypoperfusion. J Trauma. 2003 Feb;54(2):312-9. doi: 10.1097/01.TA.0000037876.37236.D6.
- Background: PubMed 11585502Manley G, Knudson MM, Morabito D, Damron S, Erickson V, Pitts L. Hypotension, hypoxia, and head injury: frequency, duration, and consequences. Arch Surg. 2001 Oct;136(10):1118-23. doi: 10.1001/archsurg.136.10.1118.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warren A Dorlac, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events during transport. (time frame: Each transport event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01077089, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2013; AzTrials last refreshed its copy on 7 Nov 2026.