Intracranial compartment syndrome in traumatic brain injury patients Circulatory System
Conditions
Interventions
The study will include patients with traumatic brain injury and intracranial compartment syndrome managed either by standard ventriculostomy or ventriculostomy plus a locking system device.
Methodolo
Sponsors
Meditech Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. TBI patients arriving at the emergency room in the first 24 hours following trauma 2. Abnormal CT scan, 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 > 6 mm on the eye at the same side of the CT´s primary injury or and/or an abnormal pupillometry with a reduced MCV in the pupil of the same side of the CT´s primary injury, or/and a TCD with PI > 1.3 and/or MCA-DV P1 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 from the trauma
Exclusion criteria
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 a 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 after the trauma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional outcomes measured using the Glasgow Outcome Scale Extended at discharge, 3 months, 6 months, and 12 months after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Control of intracranial compartment syndrome measured using ICP waveform via invasive and non-invasive devices and/or non-invasive neuromonitoring techniques (digital pupillometry, optic nerve sheath diameter ultrasonographic measurement and transcranial Doppler) daily during ICU admission 2. Frequency and type of neurosurgical interventions required measured using data collected from medical records when possible and telephone follow-up as an alternative until the end of the follow-up at 12 months after the initial surgery 3. Medical and surgical treatment intensity measured from the ICU according to the categories of stratified management of intracranial pressure proposed in the study methodology that is based on international guidelines for the management of intracranial hypertension at discharge 4. Surgical site complications measured using data collected from medical records when possible and telephone follow-up as an alternative until the end of the follow-up at 12 months after the initial surgery 5. ICU and in-hospital length of stay measured using data collected from medical records at hospital discharge | — |
Countries
Bolivia, Brazil, Cambodia, Cameroon, Chile, China, Colombia, Dominican Republic, Ecuador, Egypt, England, Guatemala, India, Italy, Mexico, Nigeria, Paraguay, Peru, Philippines, Rwanda, Serbia, South Africa, Spain, Tanzania, Thailand, United Kingdom, United States of America, Venezuela
Contacts
Public ContactSantiago Cardona
Outcome results
None listed