Traumatic Brain InjuriesSEALS-TBINCT06772155
Security and Effectiveness Assessment of Locking Systems in Ventriculostomy for Traumatic Brain Injury
An observational study of Traumatic Brain Injuries and Intracranial Hypertension, run by Meditech Foundation.
Trial summary
This study aims to compare the effectiveness and safety of a standard intervention called ventriculostomy for managing increased intracranial pressure (ICP) in patients with severe traumatic brain injury (TBI). Elevated ICP is a critical condition that can result in brain damage or death if not treated promptly. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Traumatic Brain Injuries, Intracranial Hypertension
- What is being tested?
- Ventriculostomy and Ventriculostomy + Locking Device
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 292 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2025to 31 Dec 2027
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients arriving at any of the recruitment centers (tertiary hospitals or level 1 hospitals / specialized hospitals) in any of the involved countries (Bolivia, Brazil, Cambodia, Cameroon, Chile, Colombia, Dominican Republic, Ecuador, Egypt, Guatemala, Italy, Nigeria, Paraguay, Peru, Philippines, Rwanda, Serbia, Tanzania, Thailand, Venezuela).
Who may be able to join
- TBI patients arriving at the emergency room in the first 24 hours following trauma.
- Abnormal Computed Tomography (CT), with a primary injury including any epidural, intracerebral, or subdural collection with a midline shift >3 mm and any basal cistern compression with at least 2 abnormal findings in the initial evaluation at the emergency room (including optic nerve ultrasound > 6mm on the same side of the CT´s primary injury and/or an abnormal pupillometry with a reduced Maximum Contraction Velocity (MCV) in the pupil of the same side of the CT´s primary injury, or/and a Trans-Cranial Doppler (TCD) with Pulsatility Index (PI) > 1.3 and/or Medium Cerebral Artery - Diastolic Velocity (MCA-DV) < 20cm/seg on the same side of the CT´s primary injury or/and an Intracranial Pressure Wave Form (ICPWF)2 > ICPWF1 waveform pattern on the same side of the CT´s primary injury).
- Age 18 to 70 years old.
- Patients with or without polytrauma with survival expectancy >24 hours.
- Ventriculostomy surgical procedures less than 24 hours after the trauma.
Who cannot join
- TBI patients arriving at the emergency room after 24 hours following trauma.
- Normal CT scan at the emergency room.
- Abnormal CT scan at the emergency room with any primary injury and midline shift less than 3mm or without basal cistern compression and with normal values in at least two different modalities of assessing ICCS (pupillometry, optic nerve sheath ultrasound, transcranial Doppler, and/or non-invasive ICP waveform analyzer).
- Age less than 18 or more than 70 years old.
- Polytrauma or massive brain injury with survival expectancy < 24 hours.
- Ventriculostomy surgical procedures performed > 24 hours after the trauma.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Comparative Effectiveness Study on Catheter Locking Device Versus Standard Ventriculostomy for Surgical Management of Traumatic Brain Injury Patients With Intracranial Compartment Syndrome
This study aims to compare the effectiveness and safety of a standard intervention called ventriculostomy for managing increased intracranial pressure (ICP) in patients with severe traumatic brain injury (TBI). Elevated ICP is a critical condition that can result in brain damage or death if not treated promptly. The intervention will be performed in a traditional standard way or with an additional device called a catheter locking system. The first approach, standard ventriculostomy, involves placing a catheter into the brain's ventricular system to drain cerebrospinal fluid (CSF), thereby reducing ICP. The second approach incorporates the same catheter plus a catheter-locking device designed to secure the catheter in place, potentially reducing complications such as catheter displacement and the need for additional surgeries. Participants in this study will undergo either standard ventriculostomy or ventriculostomy with the locking device. Their progress will be observed during their hospital stay until the catheter is taken out (regularly on days 5th to 7th after the initial surgery) and assessed over one year through structured telephone follow-ups. The main outcomes include functional recovery, as measured by the Glasgow Outcome Scale Extended (GOSE), and the rate of complications such as operative site infections, catheter displacement, and/or reinterventions. By comparing these two methods, the study seeks to determine whether the locking device improves outcomes for TBI patients while maintaining or enhancing the safety and reliability of the procedure.
Read the detailed description
Traumatic brain injury (TBI) patients often exhibit an increase in their intracranial volume due to blood collection or brain tissue edema. When the volume of any intracranial compartment exceeds a critical threshold, the compensatory mechanisms become overwhelmed, compromising intracranial compliance and blood supply, which leads to intracranial compartment syndrome (ICCS) and further exacerbates brain damage through secondary injury. When less invasive measures to counteract ICCS prove insufficient, ventriculostomy connected to an external ventricular drainage system is a treatment option, where positioning an intraventricular catheter by the frontal horn of the lateral ventricles is the preferred technique. Although its effectiveness has been demonstrated, ventriculostomy is also associated with a high incidence of complications. Locking devices for decreasing the movement of the catheter have been proposed as an alternative that leverages the benefits of ventriculostomy while reducing the associated adverse effects.
This study will compare the functional outcomes and complications linked to ventriculostomy and the use of locking devices for the ventricular catheter. Standard Ventriculostomy: Involves inserting a catheter into the brain's ventricular system to drain cerebrospinal fluid (CSF) and reduce intracranial pressure (ICP). This is a common procedure performed in patients with traumatic brain injury who request invasive ICP monitoring and/or CSF drainage.
The Ventriculostomy with a Locking Device is the same procedure, but it will be performed with an additional approved device, a locking system that secures the catheter in place, reducing the risk of displacement and associated complications. The system requires internal approval by regulatory entities in each one of the participant countries. Most of them already have approval and the others are in an internal approval process. Countries cannot start collecting data until they have the internal government approval for the device distribution by internal medical suppliers.
- Being tested
- Ventriculostomy, Ventriculostomy + Locking Device
- Keywords
- External Ventricular Drain, Traumatic Brain Injury, Cranial Compartment Syndrome
- Medical subject headings
- Brain Injuries, Traumatic, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VentriculostomyProcedure or surgery
Also called Intraventricular Catheter, External Ventricular Drainage
Involves inserting a catheter into the brain's ventricular system to drain cerebrospinal fluid (CSF) and reduce intracranial pressure (ICP). This is a common procedure performed in this type of patient. It can be performed by a frontal approach, using a standard point 10cm from the nasion and 3cm lateral to the midline in the skull. A burr hole is performed and then the catheter is inserted in the frontal horn of the ventricular system. Then the catheter is tunneled subcutaneously and connected to an external ventricular drain collection system that allows also ICP measurement.
Ventriculostomy + Locking DeviceProcedure or surgery
Also called Ventricular Drainage + Locking Device, External Ventricular Catheter + Locking Device
Involves inserting a catheter into the brain's ventricular system to drain cerebrospinal fluid (CSF) and reduce intracranial pressure (ICP). This is an alternative procedure performed for this type of patient. It can be performed by a frontal approach, using a standard point 10cm from the nasion and 3cm lateral to the midline in the skull. A burr hole is performed and then the catheter is inserted in the frontal horn of the ventricular system. During the insertion, a locking device is attached and secured at the burr hole defect. Then the catheter is tunneled subcutaneously and connected to an external ventricular drain collection system that allows also ICP measurement.
| Study group | Role | What they receive |
|---|---|---|
| Standard Ventriculostomy | Patients are managed with a standard ventriculostomy procedure connected to an external ventricular drain system. Receives: Procedure: Ventriculostomy | |
| Ventriculostomy + Locking Device | Patients are managed with a ventriculostomy procedure plus a locking system (NTDrain) connected to an external ventricular drain system. Receives: Procedure: Ventriculostomy + Locking Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
GOSE
Extended Glasgow Outcome Scale, evaluated from 1 to 8 points without dichotomization, with 1 being the worst outcome and 8 being the best outcome.
Measured: 12 months
Secondary outcomes (1)
Ventriculostomy Related Complications
Complications of the post-operative period related to displacements, infection, CSF disturbances, obstruction, and other technical (ICP misreadings) and medical problems associated with the intraventricular catheter.
Measured: 15 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start5 Jul 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuriesStudies of the same condition, open and under way.
- 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
- 292 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Meditech Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres M. Rubiano, Meditech Foundation
- Investigators
- Andres M Rubiano, MD, Principal investigator, Meditech FoundationLuigi V Berra, MD, Principal investigator, La Sapienza University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772155
- Sponsor's protocol ID
- CEIM-2024-12-101
- Acronym
- SEALS-TBI
- Status last verified
- May 2025
- First submitted
- 7 Jan 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated during and/or analyzed during the current study will be available upon request to the key personnel of the sponsor institution. Individual participant data (IPD) will be stored in a private repository and made available upon request. Once requested, the unprocessed data collected on the RedCap platform will be shared as soon as possible. The shared data will be anonymous, as the only identifier will be the ID assigned to patients participating in the study. No additional consents are required for sharing IPD, as this possibility is included in the informed consent.
Publications
Stuart MJ, Antony J, Withers TK, Ng W. Systematic review and meta-analysis of external ventricular drain placement accuracy and narrative review of guidance devices. J Clin Neurosci. 2021 Dec;94:140-151. doi: 10.1016/j.jocn.2021.10.014. Epub 2021 Oct 26.
PubMed 34863429Brotis AG, Karvouniaris M, Tzerefos C, Gatos C, Fountas KN. Guidelines on the use of external ventricular drain and its associated complications: do we "AGREE II"? Br J Neurosurg. 2021 Dec;35(6):689-695. doi: 10.1080/02688697.2021.1958153. Epub 2021 Aug 9.
PubMed 34365868Lele AV, Hoefnagel AL, Schloemerkemper N, Wyler DA, Chaikittisilpa N, Vavilala MS, Naik BI, Williams JH, Venkat Raghavan L, Koerner IP; Representing SNACC Task Force for Developing Guidelines for Perioperative Management of External Ventricular and Lumbar Drains. Perioperative Management of Adult Patients With External Ventricular and Lumbar Drains: Guidelines From the Society for Neuroscience in Anesthesiology and Critical Care. J Neurosurg Anesthesiol. 2017 Jul;29(3):191-210. doi: 10.1097/ANA.0000000000000407.
PubMed 28169966Fried HI, Nathan BR, Rowe AS, Zabramski JM, Andaluz N, Bhimraj A, Guanci MM, Seder DB, Singh JM. The Insertion and Management of External Ventricular Drains: An Evidence-Based Consensus Statement : A Statement for Healthcare Professionals from the Neurocritical Care Society. Neurocrit Care. 2016 Feb;24(1):61-81. doi: 10.1007/s12028-015-0224-8.
PubMed 26738503Godoy DA, Brasil S, Rubiano AM. Further support for the intracranial compartmental syndrome concept. Crit Care. 2024 Sep 18;28(1):311. doi: 10.1186/s13054-024-04974-4. No abstract available.
PubMed 39294706Martinez-Palacios K, Vasquez-Garcia S, Fariyike OA, Robba C, Rubiano AM; noninvasive intracranial pressure monitoring international consensus group. Quantitative Pupillometry for Intracranial Pressure (ICP) Monitoring in Traumatic Brain Injury: A Scoping Review. Neurocrit Care. 2024 Aug;41(1):255-271. doi: 10.1007/s12028-023-01927-7. Epub 2024 Feb 13.
PubMed 38351298Martinez-Palacios K, Vasquez-Garcia S, Fariyike OA, Robba C, Rubiano AM; noninvasive ICP monitoring international consensus group. Using Optic Nerve Sheath Diameter for Intracranial Pressure (ICP) Monitoring in Traumatic Brain Injury: A Scoping Review. Neurocrit Care. 2024 Jun;40(3):1193-1212. doi: 10.1007/s12028-023-01884-1. Epub 2023 Dec 19.
PubMed 38114797Martinez-Palacios K, Vasquez-Garcia S, Fariyike OA, Robba C, Rubiano AM. Non-Invasive Methods for Intracranial Pressure Monitoring in Traumatic Brain Injury Using Transcranial Doppler: A Scoping Review. J Neurotrauma. 2024 Jun;41(11-12):1282-1298. doi: 10.1089/neu.2023.0001. Epub 2024 Apr 11.
PubMed 37861291Godoy DA, Brasil S, Iaccarino C, Paiva W, Rubiano AM. The intracranial compartmental syndrome: a proposed model for acute brain injury monitoring and management. Crit Care. 2023 Apr 10;27(1):137. doi: 10.1186/s13054-023-04427-4.
PubMed 37038236Rubiano AM, Figaji A, Hawryluk GW. Intracranial pressure management: moving beyond guidelines. Curr Opin Crit Care. 2022 Apr 1;28(2):101-110. doi: 10.1097/MCC.0000000000000920.
PubMed 35058406Rubiano AM, Griswold DP, Jibaja M, Rabinstein AA, Godoy DA. Management of severe traumatic brain injury in regions with limited resources. Brain Inj. 2021 Sep 19;35(11):1317-1325. doi: 10.1080/02699052.2021.1972149. Epub 2021 Sep 7.
PubMed 34493135Hawryluk GWJ, Aguilera S, Buki A, Bulger E, Citerio G, Cooper DJ, Arrastia RD, Diringer M, Figaji A, Gao G, Geocadin R, Ghajar J, Harris O, Hoffer A, Hutchinson P, Joseph M, Kitagawa R, Manley G, Mayer S, Menon DK, Meyfroidt G, Michael DB, Oddo M, Okonkwo D, Patel M, Robertson C, Rosenfeld JV, Rubiano AM, Sahuquillo J, Servadei F, Shutter L, Stein D, Stocchetti N, Taccone FS, Timmons S, Tsai E, Ullman JS, Vespa P, Videtta W, Wright DW, Zammit C, Chesnut RM. A management algorithm for patients with intracranial pressure monitoring: the Seattle International Severe Traumatic Brain Injury Consensus Conference (SIBICC). Intensive Care Med. 2019 Dec;45(12):1783-1794. doi: 10.1007/s00134-019-05805-9. Epub 2019 Oct 28.
PubMed 31659383Chau CYC, Craven CL, Rubiano AM, Adams H, Tulu S, Czosnyka M, Servadei F, Ercole A, Hutchinson PJ, Kolias AG. The Evolution of the Role of External Ventricular Drainage in Traumatic Brain Injury. J Clin Med. 2019 Sep 10;8(9):1422. doi: 10.3390/jcm8091422.
PubMed 31509945Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432.
PubMed 27654000
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Effectiveness Study on Catheter Locking Device Versus Standard Ventriculostomy for Surgical Management of Traumatic Brain Injury Patients With Intracranial Compartment Syndrome
- ClinicalTrials.gov ID
- NCT06772155
- Acronym / sponsor ID
- SEALS-TBI / CEIM-2024-12-101
- Keywords
- External Ventricular Drain, Traumatic Brain Injury, Cranial Compartment Syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- Meditech FoundationUniversity, hospital or other
- Study start
- 5 Jul 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Jan 2025 (actual)
- 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.
This study aims to compare the effectiveness and safety of a standard intervention called ventriculostomy for managing increased intracranial pressure (ICP) in patients with severe traumatic brain injury (TBI). Elevated ICP is a critical condition that can result in brain damage or death if not treated promptly. The intervention will be performed in a traditional standard way or with an additional device called a catheter locking system. The first approach, standard ventriculostomy, involves placing a catheter into the brain's ventricular system to drain cerebrospinal fluid (CSF), thereby reducing ICP. The second approach incorporates the same catheter plus a catheter-locking device designed to secure the catheter in place, potentially reducing complications such as catheter displacement and the need for additional surgeries. Participants in this study will undergo either standard ventriculostomy or ventriculostomy with the locking device. Their progress will be observed during their hospital stay until the catheter is taken out (regularly on days 5th to 7th after the initial surgery) and assessed over one year through structured telephone follow-ups. The main outcomes include functional recovery, as measured by the Glasgow Outcome Scale Extended (GOSE), and the rate of complications such as operative site infections, catheter displacement, and/or reinterventions. By comparing these two methods, the study seeks to determine whether the locking device improves outcomes for TBI patients while maintaining or enhancing the safety and reliability of the procedure.
Detailed description
Traumatic brain injury (TBI) patients often exhibit an increase in their intracranial volume due to blood collection or brain tissue edema. When the volume of any intracranial compartment exceeds a critical threshold, the compensatory mechanisms become overwhelmed, compromising intracranial compliance and blood supply, which leads to intracranial compartment syndrome (ICCS) and further exacerbates brain damage through secondary injury. When less invasive measures to counteract ICCS prove insufficient, ventriculostomy connected to an external ventricular drainage system is a treatment option, where positioning an intraventricular catheter by the frontal horn of the lateral ventricles is the preferred technique. Although its effectiveness has been demonstrated, ventriculostomy is also associated with a high incidence of complications. Locking devices for decreasing the movement of the catheter have been proposed as an alternative that leverages the benefits of ventriculostomy while reducing the associated adverse effects.
This study will compare the functional outcomes and complications linked to ventriculostomy and the use of locking devices for the ventricular catheter. Standard Ventriculostomy: Involves inserting a catheter into the brain's ventricular system to drain cerebrospinal fluid (CSF) and reduce intracranial pressure (ICP). This is a common procedure performed in patients with traumatic brain injury who request invasive ICP monitoring and/or CSF drainage.
The Ventriculostomy with a Locking Device is the same procedure, but it will be performed with an additional approved device, a locking system that secures the catheter in place, reducing the risk of displacement and associated complications. The system requires internal approval by regulatory entities in each one of the participant countries. Most of them already have approval and the others are in an internal approval process. Countries cannot start collecting data until they have the internal government approval for the device distribution by internal medical suppliers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Ventriculostomy | – | Procedure: VentriculostomyPatients are managed with a standard ventriculostomy procedure connected to an external ventricular drain system. |
| Ventriculostomy + Locking Device | – | Procedure: Ventriculostomy + Locking DevicePatients are managed with a ventriculostomy procedure plus a locking system (NTDrain) connected to an external ventricular drain system. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients arriving at any of the recruitment centers (tertiary hospitals or level 1 hospitals / specialized hospitals) in any of the involved countries (Bolivia, Brazil, Cambodia, Cameroon, Chile, Colombia, Dominican Republic, Ecuador, Egypt, Guatemala, Italy, Nigeria, Paraguay, Peru, Philippines, Rwanda, Serbia, Tanzania, Thailand, Venezuela).
Key inclusion criteria (5 listed)
- TBI patients arriving at the emergency room in the first 24 hours following trauma.
- Abnormal Computed Tomography (CT), with a primary injury including any epidural, intracerebral, or subdural collection with a midline shift >3 mm and any basal cistern compression with at least 2 abnormal findings in the initial evaluation at the emergency room (including optic nerve ultrasound > 6mm on the same side of the CT´s primary injury and/or an abnormal pupillometry with a reduced Maximum Contraction Velocity (MCV) in the pupil of the same side of the CT´s primary injury, or/and a Trans-Cranial Doppler (TCD) with Pulsatility Index (PI) > 1.3 and/or Medium Cerebral Artery - Diastolic Velocity (MCA-DV) < 20cm/seg on the same side of the CT´s primary injury or/and an Intracranial Pressure Wave Form (ICPWF)2 > ICPWF1 waveform pattern on the same side of the CT´s primary injury).
- Age 18 to 70 years old.
- Patients with or without polytrauma with survival expectancy >24 hours.
- Ventriculostomy surgical procedures less than 24 hours after the trauma.
Key exclusion criteria (6 listed)
- TBI patients arriving at the emergency room after 24 hours following trauma.
- Normal CT scan at the emergency room.
- Abnormal CT scan at the emergency room with any primary injury and midline shift less than 3mm or without basal cistern compression and with normal values in at least two different modalities of assessing ICCS (pupillometry, optic nerve sheath ultrasound, transcranial Doppler, and/or non-invasive ICP waveform analyzer).
- Age less than 18 or more than 70 years old.
- Polytrauma or massive brain injury with survival expectancy < 24 hours.
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 |
|---|---|---|
| VentriculostomyAlso: Intraventricular Catheter, External Ventricular DrainageInvolves inserting a catheter into the brain's ventricular system to drain cerebrospinal fluid (CSF) and reduce intracranial pressure (ICP). This is a common procedure performed in this type of patient. It can be performed by a frontal approach, using a standard point 10cm from the nasion and 3cm lateral to the midline in the skull. A burr hole is performed and then the catheter is inserted in the frontal horn of the ventricular system. Then the catheter is tunneled subcutaneously and connected to an external ventricular drain collection system that allows also ICP measurement. | Procedure or surgery | Standard Ventriculostomy |
| Ventriculostomy + Locking DeviceAlso: Ventricular Drainage + Locking Device, External Ventricular Catheter + Locking DeviceInvolves inserting a catheter into the brain's ventricular system to drain cerebrospinal fluid (CSF) and reduce intracranial pressure (ICP). This is an alternative procedure performed for this type of patient. It can be performed by a frontal approach, using a standard point 10cm from the nasion and 3cm lateral to the midline in the skull. A burr hole is performed and then the catheter is inserted in the frontal horn of the ventricular system. During the insertion, a locking device is attached and secured at the burr hole defect. Then the catheter is tunneled subcutaneously and connected to an external ventricular drain collection system that allows also ICP measurement. | Procedure or surgery | Ventriculostomy + Locking Device |
Primary outcome
GOSE
Time frame: 12 months
Extended Glasgow Outcome Scale, evaluated from 1 to 8 points without dichotomization, with 1 being the worst outcome and 8 being the best outcome.
1 secondary outcome
Ventriculostomy Related Complications
Time frame: 15 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Background: PubMed 34863429Stuart MJ, Antony J, Withers TK, Ng W. Systematic review and meta-analysis of external ventricular drain placement accuracy and narrative review of guidance devices. J Clin Neurosci. 2021 Dec;94:140-151. doi: 10.1016/j.jocn.2021.10.014. Epub 2021 Oct 26.
- Background: PubMed 34365868Brotis AG, Karvouniaris M, Tzerefos C, Gatos C, Fountas KN. Guidelines on the use of external ventricular drain and its associated complications: do we "AGREE II"? Br J Neurosurg. 2021 Dec;35(6):689-695. doi: 10.1080/02688697.2021.1958153. Epub 2021 Aug 9.
- Background: PubMed 28169966Lele AV, Hoefnagel AL, Schloemerkemper N, Wyler DA, Chaikittisilpa N, Vavilala MS, Naik BI, Williams JH, Venkat Raghavan L, Koerner IP; Representing SNACC Task Force for Developing Guidelines for Perioperative Management of External Ventricular and Lumbar Drains. Perioperative Management of Adult Patients With External Ventricular and Lumbar Drains: Guidelines From the Society for Neuroscience in Anesthesiology and Critical Care. J Neurosurg Anesthesiol. 2017 Jul;29(3):191-210. doi: 10.1097/ANA.0000000000000407.
- Background: PubMed 26738503Fried HI, Nathan BR, Rowe AS, Zabramski JM, Andaluz N, Bhimraj A, Guanci MM, Seder DB, Singh JM. The Insertion and Management of External Ventricular Drains: An Evidence-Based Consensus Statement : A Statement for Healthcare Professionals from the Neurocritical Care Society. Neurocrit Care. 2016 Feb;24(1):61-81. doi: 10.1007/s12028-015-0224-8.
- Background: PubMed 39294706Godoy DA, Brasil S, Rubiano AM. Further support for the intracranial compartmental syndrome concept. Crit Care. 2024 Sep 18;28(1):311. doi: 10.1186/s13054-024-04974-4. No abstract available.
- Background: PubMed 38351298Martinez-Palacios K, Vasquez-Garcia S, Fariyike OA, Robba C, Rubiano AM; noninvasive intracranial pressure monitoring international consensus group. Quantitative Pupillometry for Intracranial Pressure (ICP) Monitoring in Traumatic Brain Injury: A Scoping Review. Neurocrit Care. 2024 Aug;41(1):255-271. doi: 10.1007/s12028-023-01927-7. Epub 2024 Feb 13.
- Background: PubMed 38114797Martinez-Palacios K, Vasquez-Garcia S, Fariyike OA, Robba C, Rubiano AM; noninvasive ICP monitoring international consensus group. Using Optic Nerve Sheath Diameter for Intracranial Pressure (ICP) Monitoring in Traumatic Brain Injury: A Scoping Review. Neurocrit Care. 2024 Jun;40(3):1193-1212. doi: 10.1007/s12028-023-01884-1. Epub 2023 Dec 19.
- Background: PubMed 37861291Martinez-Palacios K, Vasquez-Garcia S, Fariyike OA, Robba C, Rubiano AM. Non-Invasive Methods for Intracranial Pressure Monitoring in Traumatic Brain Injury Using Transcranial Doppler: A Scoping Review. J Neurotrauma. 2024 Jun;41(11-12):1282-1298. doi: 10.1089/neu.2023.0001. Epub 2024 Apr 11.
- Background: PubMed 37038236Godoy DA, Brasil S, Iaccarino C, Paiva W, Rubiano AM. The intracranial compartmental syndrome: a proposed model for acute brain injury monitoring and management. Crit Care. 2023 Apr 10;27(1):137. doi: 10.1186/s13054-023-04427-4.
- Background: PubMed 35058406Rubiano AM, Figaji A, Hawryluk GW. Intracranial pressure management: moving beyond guidelines. Curr Opin Crit Care. 2022 Apr 1;28(2):101-110. doi: 10.1097/MCC.0000000000000920.
- Background: PubMed 34493135Rubiano AM, Griswold DP, Jibaja M, Rabinstein AA, Godoy DA. Management of severe traumatic brain injury in regions with limited resources. Brain Inj. 2021 Sep 19;35(11):1317-1325. doi: 10.1080/02699052.2021.1972149. Epub 2021 Sep 7.
- Background: PubMed 31659383Hawryluk GWJ, Aguilera S, Buki A, Bulger E, Citerio G, Cooper DJ, Arrastia RD, Diringer M, Figaji A, Gao G, Geocadin R, Ghajar J, Harris O, Hoffer A, Hutchinson P, Joseph M, Kitagawa R, Manley G, Mayer S, Menon DK, Meyfroidt G, Michael DB, Oddo M, Okonkwo D, Patel M, Robertson C, Rosenfeld JV, Rubiano AM, Sahuquillo J, Servadei F, Shutter L, Stein D, Stocchetti N, Taccone FS, Timmons S, Tsai E, Ullman JS, Vespa P, Videtta W, Wright DW, Zammit C, Chesnut RM. A management algorithm for patients with intracranial pressure monitoring: the Seattle International Severe Traumatic Brain Injury Consensus Conference (SIBICC). Intensive Care Med. 2019 Dec;45(12):1783-1794. doi: 10.1007/s00134-019-05805-9. Epub 2019 Oct 28.
- Individual participant dataSharing planned: Yes. The datasets generated during and/or analyzed during the current study will be available upon request to the key personnel of the sponsor institution. Individual participant data (IPD) will be stored in a private repository and made available upon request. Once requested, the unprocessed data collected on the RedCap platform will be shared as soon as possible. The shared data will be anonymous, as the only identifier will be the ID assigned to patients participating in the study. No additional consents are required for sharing IPD, as this possibility is included in the informed consent.
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TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
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.
Andres M Rubiano, MD principal investigator
Meditech Foundation
Luigi V Berra, MD principal investigator
La Sapienza University
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injuries and Intracranial Hypertension, run by Meditech Foundation.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 8 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wendy Gonzalez, MD (+576023720672, gonzalez.wendy.meditechf@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GOSE (time frame: 12 months). 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 NCT06772155, which also lists 14 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 8 May 2025.