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

Launched by MEDITECH FOUNDATION · Jan 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different methods of treating patients with severe traumatic brain injuries (TBI) who have high pressure inside their skulls, a condition known as increased intracranial pressure (ICP). The standard treatment involves placing a small tube, called a catheter, into the brain to drain excess fluid and relieve pressure. The new approach being tested adds a special locking device to this catheter to help keep it securely in place, which may reduce complications like the catheter moving out of position or the need for more surgeries. The goal of the study is to see if this locking device improves recovery and reduces complications compared to the standard method.

To participate in this trial, patients must be between 18 and 70 years old and arrive at the emergency room within 24 hours after their injury. They should have specific abnormalities on their brain scans that indicate serious injury. Participants will either receive the standard treatment or the one with the locking device, and their recovery will be monitored during their hospital stay and through follow-up calls over the next year. This research aims to enhance treatment safety and effectiveness for TBI patients.

Gender

ALL

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.