Traumatic Brain InjuryDual ICPNCT02911675
Assessing the Accuracy and the Impact of Standard-practice Ventricular Drainage on Intracranial Pressure Measurements Following Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by University of Maryland, Baltimore.
Trial summary
Traumatic brain injury (TBI) is a leading cause of death following injury in civilian populations and is a major cause of death and disability in combat casualties. While primary brain injury cannot be reversed, the management of severe TBI focuses on the mitigation of secondary injury mechanisms which occur as part… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- EVD/IVC and the IPM/Camino
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2018to 24 Jan 2019
- How long will I take part?
- 6 Months
- 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: This is an interventional device study utilizing the EVD/IVC and the IPM/Camino to provide and evaluate data for optimized treatment for the control of elevated ICP and CCP in patients with severe TBI. Enrolled patients will be randomized to one of two study groups listed below following the consent process. Once a potential participant has consented to the study, we will use the excel random number generator function (randbetween(0,1)) to generate random numbers between 0 and 1 for each participant. If 0 is generated participants will be placed in Group 1 (Hourly EVD closures) and if 1 is generated, participants will be placed in Group 2 (EVD closure every 12 hours). There is no placebo or control group.
Who may be able to join
- Direct trauma admission to STC by ambulance or helicopter
- 18 years and older
- Neurosurgical evaluation indicates placement of a EVD
- Diagnosis of severe traumatic brain injury (head AIS > 2) and post-resuscitation motor CGS<6
Who cannot join
- < 18 years of age
- Non-survivable brain injury
- Non-survivable anatomic injury
- Pregnancy
- Non-English speaker
- Prisoner
- Active duty military
About this study
Traumatic brain injury (TBI) is a leading cause of death following injury in civilian populations and is a major cause of death and disability in combat casualties. While primary brain injury cannot be reversed, the management of severe TBI focuses on the mitigation of secondary injury mechanisms which occur as part of the downstream effects of the primary damage to the brain. Many secondary injury mechanisms are manifested clinically as elevated intracranial pressure (ICP) and cerebral perfusion pressure (CCP). This level and duration of elevated ICP is strongly associated with poor long term patient outcome.
Currently, there are two invasive techniques that are used at our facility for monitoring ICP and CPP. The first method requires the placement of an intra-parenchymal fiberoptic pressure monitor (IPM), also known as a camino, into the brain tissue that measures and displays ICP continuously. The second method requires placement of an extracranial ventricular drain (EVD) which both measures ICP when it is closed or clamped and also allows for therapeutic drainage of cerebral spinal fluid (CFS) to reduce pressure within the skull when it is open.
Read more
While clinical practices vary greatly across institutions, current clinical practice at our institution when using the EVD for ICP management is to allow continuous therapeutic CSF drainage and to manually close the drain for ICP assessment on an hourly basis. However, in a retrospective of study of TBI patients at our institution with simultaneous IPM and EVD placement, a spike in ICP was noted to correspond with the clamping of the EVD which often remained elevated for 15-30 minutes before returning to baseline. Due to the strong association between poor patient outcome and elevated ICP, this finding is alarming. These findings have important implications for procedures to not only treat elevated ICP, but also prevent potentially harmful intermittent elevations in ICP. Therefore, this study seeks to prospectively investigate the association between EVD clamping and elevated ICP.
Specifically, this study has 2 main objectives:
- Evaluate the need for an optimized device that can simultaneously measure intracranial pressure and drain CSF without requiring potentially harmful clamping.
- Provide data in support of retaining or modifying current clinical practices regarding intermittent versus continuous monitoring during periods of therapeutic drainage of CSF.
Read the detailed description
Investigators plan a single-center, 36 month prospective observational study of 50 patients presenting with moderate to severe traumatic brain injury (TBI) at R Adams Cowley Shock Trauma Center who require intracranial pressure monitoring. This is an interventional device study utilizing the EVD/IVC and the IPM/Camino to provide and evaluate data for optimized treatment for the control of elevated ICP and CCP in patients with severe TBI. Enrolled patients will be randomized to one of two study groups listed below following the consent process. Once a potential participant has consented to the study, we will use the excel random number generator function (randbetween(0,1)) to generate random numbers between 0 and 1 for each participant. If 0 is generated participants will be placed in Group 1 (Hourly EVD closures) and if 1 is generated, participants will be placed in Group 2 (EVD closure every 12 hours). There is no placebo or control group.
Standard of Care (25 patients): Standard EVD management with therapeutic drainage as appropriate and hourly EVD ICP measurements with simultaneous IPM/Camino ICP measurements collected.
Experimental (25 patients): Therapeutic CSF drainage as appropriate, with EVD closure and ICP assessment every 12 hours with simultaneous IPM/Camino ICP measurements collected.
Data will be collected on age, mechanism of injury, time interval between injury and MRI, past medical history, admission hemodynamics, admission component GCS, post-resuscitation component GCS, injury severity score, abbreviated injury score for head injury, blunt carotid or vertebral artery injury, and therapeutic interventions. Continuous vital signs streams will be collected.
In addition, if available, video surveillance from the patient's stay in the Neurotrauma Critical Care Unit will be collected and be stored with the patients study data.
- Conditions
- Traumatic Brain Injury
- Being tested
- EVD/IVC and the IPM/Camino
- 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.
EVD/IVC and the IPM/CaminoDevice
This is an interventional device study utilizing the EVD/IVC and the IPM/Camino to provide and evaluate data for optimized treatment for the control of elevated ICP and CCP in patients with severe TBI.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Group | Study Group 1: Standard EVD/IVC management with therapeutic CSF drainage as appropriate and hourly EVD/IVC ICP measurements per standard of care with simultaneous IPM/Camino ICP measurements collected. Receives: Device: EVD/IVC and the IPM/Camino | |
| Experimental Group | Study Group 2: Therapeutic CSF drainage as appropriate, with EVD/IVC closure and ICP assessment approximately every 12 hours with simultaneous IPM/Camino ICP measurements collected. Receives: Device: EVD/IVC and the IPM/Camino |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the need for an optimized device that can simultaneously measure intracranial pressure and drain CSF without requiring potentially harmful clamping.
Investigators want to find a better device that can measure pressure in the head after a traumatic brain without causing an increase in pressure inside of the head.
Measured: 6 months
Secondary outcomes (1)
Compare clinical practices regarding intermittent versus continuous monitoring during periods of therapeutic drainage of CSF.
Compare the current method of clamping the drain with the experimental method to determine if clamping the drain less will provide an accurate measure of pressure inside of the head.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start1 Dec 2018
- Primary completion24 Jan 2019
- Study completion24 Jan 2019
Why it stopped: Due to the lack of approval from the Air Force IRB patient enrollment was never initiated. Thus, no clinical results could be examined or can be reported
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- United States Air Force
- Responsible party
- Principal investigator, Deborah Stein, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911675
- Sponsor's protocol ID
- HP-00064113
- Acronym
- Dual ICP
- Status last verified
- Jan 2022
- First submitted
- 24 Aug 2016
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Accuracy and the Impact of Standard-practice Ventricular Drainage on Intracranial Pressure Measurements Following Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02911675
- Acronym / sponsor ID
- Dual ICP / HP-00064113
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to the lack of approval from the Air Force IRB patient enrollment was never initiated. Thus, no clinical results could be examined or can be reported
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- United States Air Force
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 24 Jan 2019 (actual)
- Study completion
- 24 Jan 2019 (actual)
- First posted
- 22 Sep 2016 (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.
Traumatic brain injury (TBI) is a leading cause of death following injury in civilian populations and is a major cause of death and disability in combat casualties. While primary brain injury cannot be reversed, the management of severe TBI focuses on the mitigation of secondary injury mechanisms which occur as part of the downstream effects of the primary damage to the brain. Many secondary injury mechanisms are manifested clinically as elevated intracranial pressure (ICP) and cerebral perfusion pressure (CCP). This level and duration of elevated ICP is strongly associated with poor long term patient outcome.
Currently, there are two invasive techniques that are used at our facility for monitoring ICP and CPP. The first method requires the placement of an intra-parenchymal fiberoptic pressure monitor (IPM), also known as a camino, into the brain tissue that measures and displays ICP continuously. The second method requires placement of an extracranial ventricular drain (EVD) which both measures ICP when it is closed or clamped and also allows for therapeutic drainage of cerebral spinal fluid (CFS) to reduce pressure within the skull when it is open.
While clinical practices vary greatly across institutions, current clinical practice at our institution when using the EVD for ICP management is to allow continuous therapeutic CSF drainage and to manually close the drain for ICP assessment on an hourly basis. However, in a retrospective of study of TBI patients at our institution with simultaneous IPM and EVD placement, a spike in ICP was noted to correspond with the clamping of the EVD which often remained elevated for 15-30 minutes before returning to baseline. Due to the strong association between poor patient outcome and elevated ICP, this finding is alarming. These findings have important implications for procedures to not only treat elevated ICP, but also prevent potentially harmful intermittent elevations in ICP. Therefore, this study seeks to prospectively investigate the association between EVD clamping and elevated ICP.
Specifically, this study has 2 main objectives:
- Evaluate the need for an optimized device that can simultaneously measure intracranial pressure and drain CSF without requiring potentially harmful clamping.
- Provide data in support of retaining or modifying current clinical practices regarding intermittent versus continuous monitoring during periods of therapeutic drainage of CSF.
Detailed description
Investigators plan a single-center, 36 month prospective observational study of 50 patients presenting with moderate to severe traumatic brain injury (TBI) at R Adams Cowley Shock Trauma Center who require intracranial pressure monitoring. This is an interventional device study utilizing the EVD/IVC and the IPM/Camino to provide and evaluate data for optimized treatment for the control of elevated ICP and CCP in patients with severe TBI. Enrolled patients will be randomized to one of two study groups listed below following the consent process. Once a potential participant has consented to the study, we will use the excel random number generator function (randbetween(0,1)) to generate random numbers between 0 and 1 for each participant. If 0 is generated participants will be placed in Group 1 (Hourly EVD closures) and if 1 is generated, participants will be placed in Group 2 (EVD closure every 12 hours). There is no placebo or control group.
Standard of Care (25 patients): Standard EVD management with therapeutic drainage as appropriate and hourly EVD ICP measurements with simultaneous IPM/Camino ICP measurements collected.
Experimental (25 patients): Therapeutic CSF drainage as appropriate, with EVD closure and ICP assessment every 12 hours with simultaneous IPM/Camino ICP measurements collected.
Data will be collected on age, mechanism of injury, time interval between injury and MRI, past medical history, admission hemodynamics, admission component GCS, post-resuscitation component GCS, injury severity score, abbreviated injury score for head injury, blunt carotid or vertebral artery injury, and therapeutic interventions. Continuous vital signs streams will be collected.
In addition, if available, video surveillance from the patient's stay in the Neurotrauma Critical Care Unit will be collected and be stored with the patients study data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Group | – | Device: EVD/IVC and the IPM/CaminoStudy Group 1: Standard EVD/IVC management with therapeutic CSF drainage as appropriate and hourly EVD/IVC ICP measurements per standard of care with simultaneous IPM/Camino ICP measurements collected. |
| Experimental Group | – | Device: EVD/IVC and the IPM/CaminoStudy Group 2: Therapeutic CSF drainage as appropriate, with EVD/IVC closure and ICP assessment approximately every 12 hours with simultaneous IPM/Camino ICP measurements collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is an interventional device study utilizing the EVD/IVC and the IPM/Camino to provide and evaluate data for optimized treatment for the control of elevated ICP and CCP in patients with severe TBI. Enrolled patients will be randomized to one of two study groups listed below following the consent process. Once a potential participant has consented to the study, we will use the excel random number generator function (randbetween(0,1)) to generate random numbers between 0 and 1 for each participant. If 0 is generated participants will be placed in Group 1 (Hourly EVD closures) and if 1 is generated, participants will be placed in Group 2 (EVD closure every 12 hours). There is no placebo or control group.
Key inclusion criteria (4 listed)
- Direct trauma admission to STC by ambulance or helicopter
- 18 years and older
- Neurosurgical evaluation indicates placement of a EVD
- Diagnosis of severe traumatic brain injury (head AIS > 2) and post-resuscitation motor CGS<6
Key exclusion criteria (7 listed)
- < 18 years of age
- Non-survivable brain injury
- Non-survivable anatomic injury
- Pregnancy
- Non-English speaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVD/IVC and the IPM/CaminoThis is an interventional device study utilizing the EVD/IVC and the IPM/Camino to provide and evaluate data for optimized treatment for the control of elevated ICP and CCP in patients with severe TBI. | Device | Experimental Group, Standard of Care Group |
Primary outcome
Evaluate the need for an optimized device that can simultaneously measure intracranial pressure and drain CSF without requiring potentially harmful clamping.
Time frame: 6 months
Investigators want to find a better device that can measure pressure in the head after a traumatic brain without causing an increase in pressure inside of the head.
1 secondary outcome
Compare clinical practices regarding intermittent versus continuous monitoring during periods of therapeutic drainage of CSF.
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by University of Maryland, Baltimore.
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 7 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: withdrawn, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Evaluate the need for an optimized device that can simultaneously measure intracranial pressure and drain CSF without requiring potentially harmful clamping. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2022.