Effectiveness of Surgical Procedures for Acute Cranial Expansion in Traumatic Brain Injury

Launched by MEDITECH FOUNDATION · Jan 14, 2025

Keywords

ClinConnect Summary

This clinical trial aims to compare two surgical procedures for patients who have suffered a traumatic brain injury (TBI) and are experiencing increased pressure inside the skull, known as intracranial hypertension. When traditional methods to relieve this pressure don’t work, doctors may perform a surgery called decompressive craniectomy (DC), which removes a part of the skull to allow the brain to swell. However, this procedure can lead to complications. The trial will explore whether a different approach, called expansive craniotomy (EC), can provide better benefits with fewer risks.

To be eligible for this study, participants must be between 18 and 70 years old and have suffered a TBI within the first 24 hours, showing specific signs on their initial CT scan. This includes signs of bleeding or swelling in the brain that could lead to increased pressure. Participants will be monitored to see how well each surgical method works and any complications that may arise. This research is important as it could help identify the safest and most effective surgical options 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 \>3mm and any basal cistern compression with at least 2 abnormal findings in the initial evaluation at the emergency room (including optic nerve ultrasound \> 6mm at the same side of the CT´s primary injury or 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 Middle Cerebral Artery - Diastolic Velocity (MCA-DV) \< 20cm/seg on the same side of the CT´s primary injury or/and an Intracranial Pressure Pulse Wave (ICPPW) ICPPW2 \> ICPPW1 waveform pattern in 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. Cranial decompression or cranial expansion 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. Cranial decompression or cranial expansion surgical procedures performed \> 24 hours after the trauma.