Security and Effectiveness Assessment of Locking Systems in Ventriculostomy for Traumatic Brain Injury

NCT06772155 | Not Yet Recruiting DMC

• 1 other identifier: CEIM-2024-12-101
• Study Type: observational
• Target: 292
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Traumatic Brain Injuries; Intracranial Hypertension

Keywords

External Ventricular Drain; Traumatic Brain Injury; Cranial Compartment Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• Ventriculostomy Related Complications

  15 days.

Study Arms (2)

Standard Ventriculostomy

Patients are managed with a standard ventriculostomy procedure connected to an external ventricular drain system.

Procedure: Ventriculostomy

Ventriculostomy + Locking Device

Patients are managed with a ventriculostomy procedure plus a locking system (NTDrain) connected to an external ventricular drain system.

Procedure: Ventriculostomy + Locking Device

Interventions

Ventriculostomy PROCEDURE

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.

Also known as: Intraventricular Catheter, External Ventricular Drainage

Standard Ventriculostomy

Ventriculostomy + Locking Device PROCEDURE

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.

Also known as: Ventricular Drainage + Locking Device, External Ventricular Catheter + Locking Device

Ventriculostomy + Locking Device

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meditech Foundation: lead

Related Publications (14)

• 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.

  PMID: 34863429 BACKGROUND

• Brotis 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.

  PMID: 34365868 BACKGROUND

• Lele 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.

  PMID: 28169966 BACKGROUND

• Fried 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.

  PMID: 26738503 BACKGROUND

• Godoy 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.

  PMID: 39294706 BACKGROUND

• Martinez-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.

  PMID: 38351298 BACKGROUND

• Martinez-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.

  PMID: 38114797 BACKGROUND

• Martinez-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.

  PMID: 37861291 BACKGROUND

• Godoy 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.

  PMID: 37038236 BACKGROUND

• Rubiano 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.

  PMID: 35058406 BACKGROUND

• Rubiano 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.

  PMID: 34493135 BACKGROUND

• Hawryluk 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.

  PMID: 31659383 BACKGROUND

• Chau 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.

  PMID: 31509945 BACKGROUND

• Carney 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.

  PMID: 27654000 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Intracranial Hypertension

Interventions

Ventriculostomy

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cerebrospinal Fluid Shunts; Anastomosis, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Andres M Rubiano, MD

  Meditech Foundation

  PRINCIPAL INVESTIGATOR

• Luigi V Berra, MD

  La Sapienza University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Gonzalez, MD

CONTACT

+576023720672; gonzalez.wendy.meditechf@outlook.com

Santiago Cardona, MD

CONTACT

+576023720672; cardona.santiago.meditechf@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: July 5, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From June 2025 to June 2027
• Access Criteria: The datasets generated during and/or analyzed during the current study will be available upon request to the key personnel of the sponsor institution (see contact information). 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.