Clinical trial NCT06772155: Security and Effectiveness Assessment of Locking Systems in Ventriculostomy for Traumatic Brain Injury
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Traumatic Brain Injuries
Intracranial Hypertension
Keywords: External Ventricular Drain
Traumatic Brain Injury
Cranial Compartment Syndrome
Lead sponsor: Meditech Foundation
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: GOSE
timeFrame: 12 months
Secondary outcomes:
measure: Ventriculostomy Related Complications
timeFrame: 15 days.
Other outcomes:
Locations:
Study officials:
affiliation: Meditech Foundation
name: Andres M Rubiano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: La Sapienza University
name: Luigi V Berra, MD
role: PRINCIPAL_INVESTIGATOR
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