NCT06776614Not yet recruiting
Effectiveness of Surgical Procedures for Acute Cranial Expansion in Traumatic Brain Injury
A Comparative-effectiveness Study on Expansion Craniotomy Versus Decompressive Craniectomy for Surgical Management of Traumatic Brain Injury in Patients With Intracranial Compartment Syndrome
Source: ClinicalTrials.gov · Last updated 8 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 exhausted, compromising intracranial compliance and blood supply, which leads to intracranial compartment syndrome (ICCS). The presence of this condition exacerbates brain damage through secondary injury. When less invasive measures to counteract ICCS prove to be insufficient, cranial decompression is recommended, with decompressive craniectomy (DC) being the preferred technique. Although its effectiveness has been demonstrated, DC is also associated with an incidence of complications. Expansive craniotomy (EC) has been proposed as an alternative that can increase the benefits of cranial decompression provided by DC while reducing the associated complications. This observational study will compare the functional outcomes and complications of patients managed by DC and EC.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 292 (estimated)
- First submitted
- 7 Jan 2025
- Start date
- 8 Jul 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Meditech Foundation
- Diseases
- High blood pressure
- NCT number
- NCT06776614
What you commit to
- Study type: Observational
- Planned participants: 292
- From 8 Jul 2025 to the primary completion date, 30 Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cranial decompression or cranial expansion surgical procedures performed \> 24 hours after the trauma.
Age
- Age less than 18 or more than 70 years old.
Other
- 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).
- Polytrauma or massive brain injury with survival expectancy \< 24 hours.
Who the study is looking for
- 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 \>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).
- Age 18 to 70 years old.
- Patients with or without polytrauma with survival expectancy \>24 hours.
- Cranial decompression or cranial expansion surgical procedures less than 24 hours after the trauma.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.