Security and Effectiveness Assessment of Locking Systems in Ventriculostomy for Traumatic Brain Injury (SEALS-TBI)

May 5, 2025 updated by: Andres M. Rubiano, Meditech Foundation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

292

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

Inclusion Criteria:

  1. TBI patients arriving at the emergency room in the first 24 hours following trauma.
  2. 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).
  3. Age 18 to 70 years old.
  4. Patients with or without polytrauma with survival expectancy >24 hours.
  5. Ventriculostomy surgical procedures less than 24 hours after the trauma.

Exclusion Criteria:

  1. TBI patients arriving at the emergency room after 24 hours following trauma.
  2. Normal CT scan at the emergency room.
  3. 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).
  4. Age less than 18 or more than 70 years old.
  5. Polytrauma or massive brain injury with survival expectancy < 24 hours.
  6. Ventriculostomy surgical procedures performed > 24 hours after the trauma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Standard Ventriculostomy
Patients are managed with a standard ventriculostomy procedure connected to an external ventricular drain system.
Procedure: 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 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.
Other Names:
  • Intraventricular Catheter
  • External Ventricular Drainage
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
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.
Other Names:
  • Ventricular Drainage + Locking Device
  • External Ventricular Catheter + Locking Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventriculostomy Related Complications
Time Frame: 15 days.
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.
15 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meditech Foundation

Investigators

  • Principal Investigator: Andres M Rubiano, MD, Meditech Foundation
  • Principal Investigator: Luigi V Berra, MD, La Sapienza University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 5, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

January 13, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIM-2024-12-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

From June 2025 to June 2027

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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