Traumatic Brain InjuriesE-SPACE-TBINCT06776614
Effectiveness of Surgical Procedures for Acute Cranial Expansion in Traumatic Brain Injury
An observational study of Traumatic Brain Injuries and Intracranial Hypertension, run by Meditech Foundation.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Traumatic Brain Injuries, Intracranial Hypertension
- What is being tested?
- Decompressive Craniectomy and Expansion Craniotomy
- Type of treatment
- Surgery or procedure
- How many people
- 292 participants
- Where
- No sites listed yet
- Study dates
- 8 Jul 2025to 31 Dec 2027
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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).
- Age less than 18 or more than 70 years old.
- Polytrauma or massive brain injury with survival expectancy < 24 hours.
- Cranial decompression or cranial expansion surgical procedures performed > 24 hours after the trauma.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Comparative-effectiveness Study on Expansion Craniotomy Versus Decompressive Craniectomy for Surgical Management of Traumatic Brain Injury in Patients With Intracranial Compartment Syndrome
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.
Read the detailed description
In cranial decompression, a cranial vault bone graft is removed and left out to be stored in a bone bank or an abdominal pouch generated during the surgery. In the cranial expansion, the cranial vault bone graft is fixed in an elevated position 1 - 1.5 cm above the external cranial table and fixed by 3-5 metallic plates placed during surgery.
Participants' progress will be observed during their hospital stay and assessed for 1 year through structured telephone follow-ups. The main outcomes will include functional recovery and the rate of complications such as operative site infections, and/or reinterventions. By comparing these two surgical methods, the study seeks to determine whether the expansion craniotomy improves outcomes for TBI patients while maintaining or enhancing the safety and reliability of the cranial decompression procedure.
Currently, decompressive craniectomy (DC) is the most frequently used technique. The Brain Trauma Foundation's current guidelines discuss it and describe the actual evidence. This technique will serve as a comparator for expansion craniotomy (EC). The allocation of patients to the intervention will be based on the clinical criteria of the treating neurosurgeon as long as the patients meet the inclusion criteria and do not present any exclusion criteria.
Neurosurgeons will describe the reason(s) why one technique or another was indicated and why the surgical approach was selected. The EC technique is standardized and will be performed through a retro-auricular "C-shape" incision and executing a 15x15 cm craniotomy with a "C-shape" durotomy. Dural closure will be at the discretion of the surgeon and the availability of resources, including duroplasty with aponeurotic galea, a suturable dural patch, a non-suturable dural patch, or simply a superficial dural cover with hemostatic materials like Surgicel® or Gelfoam®.
The expansion craniotomy will be finished with a cranioplasty using specific mini plates (3-5 "Rialto" plates) for bone fixation.
There are multiple techniques for DC. The elected technique will be at the discretion of the treating neurosurgeon, but only frontal-parietal-temporal DC will be considered. The removed bone flap may be stored in an abdominal pouch in the right or left upper abdominal quadrants or by freezing in a bone or blood bank freezer. Patients who receive an EC may subsequently be taken to DC if the expected improvement is not achieved with the intervention, according to the postsurgical images and invasive and noninvasive neuromonitoring, based on the criteria of the treating neurosurgeon. If this happens, the treating neurosurgeon must specify why they opted for the procedure. On the other hand, the intervention cannot be changed in patients taken to DC once the surgery is completed since the bone would have already been removed and stored.
- Being tested
- Decompressive Craniectomy, Expansion Craniotomy
- Keywords
- Traumatic Brain Injury, Intracranial Compartment Syndrome, Decompressive Craniectomy, Expansive Craniotomy
- Medical subject headings
- Brain Injuries, Traumatic, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompressive CraniectomyProcedure or surgery
Also called Cranial Decompression, Hemi Craniectomy
The DC will be performed through a standard trauma incision, a retro-auricular "C-shape" or a "Kempe" incision and execute a 15x15 cm craniotomy with a "C-shape" durotomy. Dural closure will be at the discretion of the surgeon and the availability of resources, including duroplasty with aponeurotic galea, a suturable dural patch, a non-suturable dural patch, or simply a superficial dural cover with hemostatic materials like Surgicel® or Gelfoam®. There are multiple techniques for DC. The elected technique will be at the discretion of the treating neurosurgeon, but only front-parietal-temporal DC will be considered. The removed bone flap may be stored in an abdominal pouch in the right or left upper abdominal quadrants or by freezing in a bone or blood bank freezer.
Expansion CraniotomyProcedure or surgery
Also called Hinge Craniotomy
The EC will be performed through a retro-auricular "C-shape" incision and executing a 15x15 cm craniotomy with a "C-shape" durotomy. Dural closure will be at the discretion of the surgeon and the availability of resources, including duroplasty with aponeurotic galea, a suturable dural patch, a non-suturable dural patch, or simply a superficial dural cover with hemostatic materials like Surgicel® or Gelfoam®. The expansion craniotomy will be finished with a cranioplasty using a full set of 3-5 "Rialto" plates for bone graft closure. The selected technique will be at the discretion of the treating neurosurgeon, but only front-parietal-temporal EC will be considered.
| Study group | Role | What they receive |
|---|---|---|
| Decompressive Craniectomy Group | Patients with early emergency room (ER) diagnosis of intracranial compartment syndrome who underwent a classical hemicranial decompressive craniectomy procedure Receives: Procedure: Decompressive Craniectomy | |
| Expansion Craniotomy Group | Patients with early ER diagnosis of intracranial compartment syndrome underwent a specific decompressive craniectomy procedure called expansion craniotomy, with fixation of the bone graft 1cm over the external table of the skull with a set of specific mini plates (Rialto System). Receives: Procedure: Expansion Craniotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
GOSE
Standard GOSE Evaluation without dichotomization.
Measured: Glasgow Outcome Scale Extended in different periods during one year
Secondary outcomes (1)
Surgical Site Complications
Post-operative CSF disturbances, surgical site infection, wound complications, number of required re-interventions.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start8 Jul 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 292 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Meditech Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres M. Rubiano, Meditech Foundation
- Investigators
- Andres M Rubiano, MD, Principal investigator, Meditech FoundationLuigi V Berra, MD, Principal investigator, La Sapienza University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776614
- Sponsor's protocol ID
- CEIM-2024-12-102
- Acronym
- E-SPACE-TBI
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated during and/or analyzed during the current study will be available upon request to the key personnel of the sponsor institution. Individual participant data (IPD) will be stored in a private repository and made available upon request. Once requested, the unprocessed data collected on the RedCap platform will be shared as soon as possible. The shared data will be anonymous, as the only identifier will be the ID assigned to patients participating in the study. No additional consents are required for sharing IPD, as this possibility is included in the informed consent.
Publications
Berra LV, Cedrone G, Di Norcia V, D'Angelo L, Brunetto F, Familiari P, Palmieri M, Capobianco M, Pappone F, Santoro A. Development of a Novel Device for Decompressive Craniectomy: An Experimental and Cadaveric Study and Preliminary Clinical Application. Oper Neurosurg. 2023 Mar 1;24(3):324-330. doi: 10.1227/ons.0000000000000530. Epub 2022 Dec 12.
PubMed 36701747Godoy DA, Brasil S, Rubiano AM. Further support for the intracranial compartmental syndrome concept. Crit Care. 2024 Sep 18;28(1):311. doi: 10.1186/s13054-024-04974-4. No abstract available.
PubMed 39294706Palavani LB, Alves Neto LB, Batista S, Ferreira MY, Emmily de Carvalho D, de Vasconcellos Piscoya G, Teodoro Ramos Cabral Angelim Frazao C, Alves Leite JG, Fernandes MQ, Vieira Nogueira B, Godoy DA, Brasil S, Rubiano AM, Bertani de Magalhaes R, Paiva WS. Invasive and Noninvasive Techniques for Intracranial Pressure Monitoring After Decompressive Craniectomy: A Systematic Review and Meta-Analysis. World Neurosurg. 2024 Oct;190:76-87. doi: 10.1016/j.wneu.2024.06.118. Epub 2024 Jun 29.
PubMed 38950649Martinez-Palacios K, Vasquez-Garcia S, Fariyike OA, Robba C, Rubiano AM; noninvasive intracranial pressure monitoring international consensus group. Quantitative Pupillometry for Intracranial Pressure (ICP) Monitoring in Traumatic Brain Injury: A Scoping Review. Neurocrit Care. 2024 Aug;41(1):255-271. doi: 10.1007/s12028-023-01927-7. Epub 2024 Feb 13.
PubMed 38351298Martinez-Palacios K, Vasquez-Garcia S, Fariyike OA, Robba C, Rubiano AM; noninvasive ICP monitoring international consensus group. Using Optic Nerve Sheath Diameter for Intracranial Pressure (ICP) Monitoring in Traumatic Brain Injury: A Scoping Review. Neurocrit Care. 2024 Jun;40(3):1193-1212. doi: 10.1007/s12028-023-01884-1. Epub 2023 Dec 19.
PubMed 38114797Martinez-Palacios K, Vasquez-Garcia S, Fariyike OA, Robba C, Rubiano AM. Non-Invasive Methods for Intracranial Pressure Monitoring in Traumatic Brain Injury Using Transcranial Doppler: A Scoping Review. J Neurotrauma. 2024 Jun;41(11-12):1282-1298. doi: 10.1089/neu.2023.0001. Epub 2024 Apr 11.
PubMed 37861291Godoy DA, Brasil S, Iaccarino C, Paiva W, Rubiano AM. The intracranial compartmental syndrome: a proposed model for acute brain injury monitoring and management. Crit Care. 2023 Apr 10;27(1):137. doi: 10.1186/s13054-023-04427-4.
PubMed 37038236Rubiano AM, Figaji A, Hawryluk GW. Intracranial pressure management: moving beyond guidelines. Curr Opin Crit Care. 2022 Apr 1;28(2):101-110. doi: 10.1097/MCC.0000000000000920.
PubMed 35058406Mohan M, Layard Horsfall H, Solla DJF, Robertson FC, Adeleye AO, Teklemariam TL, Khan MM, Servadei F, Khan T, Karekezi C, Rubiano AM, Hutchinson PJ, Paiva WS, Kolias AG, Devi BI; NIHR Global Health Research Group on Neurotrauma. Decompressive craniotomy: an international survey of practice. Acta Neurochir (Wien). 2021 May;163(5):1415-1422. doi: 10.1007/s00701-021-04783-6. Epub 2021 Mar 18.
PubMed 33738561Iaccarino C, Kolias A, Adelson PD, Rubiano AM, Viaroli E, Buki A, Cinalli G, Fountas K, Khan T, Signoretti S, Waran V, Adeleye AO, Amorim R, Bertuccio A, Cama A, Chesnut RM, De Bonis P, Estraneo A, Figaji A, Florian SI, Formisano R, Frassanito P, Gatos C, Germano A, Giussani C, Hossain I, Kasprzak P, La Porta F, Lindner D, Maas AIR, Paiva W, Palma P, Park KB, Peretta P, Pompucci A, Posti J, Sengupta SK, Sinha A, Sinha V, Stefini R, Talamonti G, Tasiou A, Zona G, Zucchelli M, Hutchinson PJ, Servadei F. Consensus statement from the international consensus meeting on post-traumatic cranioplasty. Acta Neurochir (Wien). 2021 Feb;163(2):423-440. doi: 10.1007/s00701-020-04663-5. Epub 2020 Dec 22.
PubMed 33354733Hawryluk GWJ, Rubiano AM, Totten AM, O'Reilly C, Ullman JS, Bratton SL, Chesnut R, Harris OA, Kissoon N, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Lumba-Brown A, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury: 2020 Update of the Decompressive Craniectomy Recommendations. Neurosurgery. 2020 Sep 1;87(3):427-434. doi: 10.1093/neuros/nyaa278.
PubMed 32761068Layard Horsfall H, Mohan M, Devi BI, Adeleye AO, Shukla DP, Bhat D, Khan M, Clark DJ, Chari A, Servadei F, Khan T, Rubiano AM, Hutchinson PJ, Kolias AG. Hinge/floating craniotomy as an alternative technique for cerebral decompression: a scoping review. Neurosurg Rev. 2020 Dec;43(6):1493-1507. doi: 10.1007/s10143-019-01180-7. Epub 2019 Nov 11.
PubMed 31712994Hutchinson PJ, Kolias AG, Tajsic T, Adeleye A, Aklilu AT, Apriawan T, Bajamal AH, Barthelemy EJ, Devi BI, Bhat D, Bulters D, Chesnut R, Citerio G, Cooper DJ, Czosnyka M, Edem I, El-Ghandour NMF, Figaji A, Fountas KN, Gallagher C, Hawryluk GWJ, Iaccarino C, Joseph M, Khan T, Laeke T, Levchenko O, Liu B, Liu W, Maas A, Manley GT, Manson P, Mazzeo AT, Menon DK, Michael DB, Muehlschlegel S, Okonkwo DO, Park KB, Rosenfeld JV, Rosseau G, Rubiano AM, Shabani HK, Stocchetti N, Timmons SD, Timofeev I, Uff C, Ullman JS, Valadka A, Waran V, Wells A, Wilson MH, Servadei F. Consensus statement from the International Consensus Meeting on the Role of Decompressive Craniectomy in the Management of Traumatic Brain Injury : Consensus statement. Acta Neurochir (Wien). 2019 Jul;161(7):1261-1274. doi: 10.1007/s00701-019-03936-y. Epub 2019 May 28.
PubMed 31134383Clavijo A, Khan AA, Mendoza J, Montenegro JH, Johnson ED, Adeleye AO, Rubiano AM. The Role of Decompressive Craniectomy in Limited Resource Environments. Front Neurol. 2019 Feb 26;10:112. doi: 10.3389/fneur.2019.00112. eCollection 2019.
PubMed 30863354Rubiano AM, Maldonado M, Montenegro J, Restrepo CM, Khan AA, Monteiro R, Faleiro RM, Carreno JN, Amorim R, Paiva W, Munoz E, Paranhos J, Soto A, Armonda R, Rosenfeld JV. The Evolving Concept of Damage Control in Neurotrauma: Application of Military Protocols in Civilian Settings with Limited Resources. World Neurosurg. 2019 May;125:e82-e93. doi: 10.1016/j.wneu.2019.01.005. Epub 2019 Jan 16.
PubMed 30659971
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative-effectiveness Study on Expansion Craniotomy Versus Decompressive Craniectomy for Surgical Management of Traumatic Brain Injury in Patients With Intracranial Compartment Syndrome
- ClinicalTrials.gov ID
- NCT06776614
- Acronym / sponsor ID
- E-SPACE-TBI / CEIM-2024-12-102
- Keywords
- Traumatic Brain Injury, Intracranial Compartment Syndrome, Decompressive Craniectomy, Expansive Craniotomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- Meditech FoundationUniversity, hospital or other
- Study start
- 8 Jul 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In cranial decompression, a cranial vault bone graft is removed and left out to be stored in a bone bank or an abdominal pouch generated during the surgery. In the cranial expansion, the cranial vault bone graft is fixed in an elevated position 1 - 1.5 cm above the external cranial table and fixed by 3-5 metallic plates placed during surgery.
Participants' progress will be observed during their hospital stay and assessed for 1 year through structured telephone follow-ups. The main outcomes will include functional recovery and the rate of complications such as operative site infections, and/or reinterventions. By comparing these two surgical methods, the study seeks to determine whether the expansion craniotomy improves outcomes for TBI patients while maintaining or enhancing the safety and reliability of the cranial decompression procedure.
Currently, decompressive craniectomy (DC) is the most frequently used technique. The Brain Trauma Foundation's current guidelines discuss it and describe the actual evidence. This technique will serve as a comparator for expansion craniotomy (EC). The allocation of patients to the intervention will be based on the clinical criteria of the treating neurosurgeon as long as the patients meet the inclusion criteria and do not present any exclusion criteria.
Neurosurgeons will describe the reason(s) why one technique or another was indicated and why the surgical approach was selected. The EC technique is standardized and will be performed through a retro-auricular "C-shape" incision and executing a 15x15 cm craniotomy with a "C-shape" durotomy. Dural closure will be at the discretion of the surgeon and the availability of resources, including duroplasty with aponeurotic galea, a suturable dural patch, a non-suturable dural patch, or simply a superficial dural cover with hemostatic materials like Surgicel® or Gelfoam®.
The expansion craniotomy will be finished with a cranioplasty using specific mini plates (3-5 "Rialto" plates) for bone fixation.
There are multiple techniques for DC. The elected technique will be at the discretion of the treating neurosurgeon, but only frontal-parietal-temporal DC will be considered. The removed bone flap may be stored in an abdominal pouch in the right or left upper abdominal quadrants or by freezing in a bone or blood bank freezer. Patients who receive an EC may subsequently be taken to DC if the expected improvement is not achieved with the intervention, according to the postsurgical images and invasive and noninvasive neuromonitoring, based on the criteria of the treating neurosurgeon. If this happens, the treating neurosurgeon must specify why they opted for the procedure. On the other hand, the intervention cannot be changed in patients taken to DC once the surgery is completed since the bone would have already been removed and stored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decompressive Craniectomy Group | – | Procedure: Decompressive CraniectomyPatients with early emergency room (ER) diagnosis of intracranial compartment syndrome who underwent a classical hemicranial decompressive craniectomy procedure |
| Expansion Craniotomy Group | – | Procedure: Expansion CraniotomyPatients with early ER diagnosis of intracranial compartment syndrome underwent a specific decompressive craniectomy procedure called expansion craniotomy, with fixation of the bone graft 1cm over the external table of the skull with a set of specific mini plates (Rialto System). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
- Age less than 18 or more than 70 years old.
- Polytrauma or massive brain injury with survival expectancy < 24 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decompressive CraniectomyAlso: Cranial Decompression, Hemi CraniectomyThe DC will be performed through a standard trauma incision, a retro-auricular "C-shape" or a "Kempe" incision and execute a 15x15 cm craniotomy with a "C-shape" durotomy. Dural closure will be at the discretion of the surgeon and the availability of resources, including duroplasty with aponeurotic galea, a suturable dural patch, a non-suturable dural patch, or simply a superficial dural cover with hemostatic materials like Surgicel® or Gelfoam®. There are multiple techniques for DC. The elected technique will be at the discretion of the treating neurosurgeon, but only front-parietal-temporal DC will be considered. The removed bone flap may be stored in an abdominal pouch in the right or left upper abdominal quadrants or by freezing in a bone or blood bank freezer. | Procedure or surgery | Decompressive Craniectomy Group |
| Expansion CraniotomyAlso: Hinge CraniotomyThe EC will be performed through a retro-auricular "C-shape" incision and executing a 15x15 cm craniotomy with a "C-shape" durotomy. Dural closure will be at the discretion of the surgeon and the availability of resources, including duroplasty with aponeurotic galea, a suturable dural patch, a non-suturable dural patch, or simply a superficial dural cover with hemostatic materials like Surgicel® or Gelfoam®. The expansion craniotomy will be finished with a cranioplasty using a full set of 3-5 "Rialto" plates for bone graft closure. The selected technique will be at the discretion of the treating neurosurgeon, but only front-parietal-temporal EC will be considered. | Procedure or surgery | Expansion Craniotomy Group |
Primary outcome
GOSE
Time frame: Glasgow Outcome Scale Extended in different periods during one year
Standard GOSE Evaluation without dichotomization.
1 secondary outcome
Surgical Site Complications
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Background: PubMed 36701747Berra LV, Cedrone G, Di Norcia V, D'Angelo L, Brunetto F, Familiari P, Palmieri M, Capobianco M, Pappone F, Santoro A. Development of a Novel Device for Decompressive Craniectomy: An Experimental and Cadaveric Study and Preliminary Clinical Application. Oper Neurosurg. 2023 Mar 1;24(3):324-330. doi: 10.1227/ons.0000000000000530. Epub 2022 Dec 12.
- Background: PubMed 39294706Godoy DA, Brasil S, Rubiano AM. Further support for the intracranial compartmental syndrome concept. Crit Care. 2024 Sep 18;28(1):311. doi: 10.1186/s13054-024-04974-4. No abstract available.
- Background: PubMed 38950649Palavani LB, Alves Neto LB, Batista S, Ferreira MY, Emmily de Carvalho D, de Vasconcellos Piscoya G, Teodoro Ramos Cabral Angelim Frazao C, Alves Leite JG, Fernandes MQ, Vieira Nogueira B, Godoy DA, Brasil S, Rubiano AM, Bertani de Magalhaes R, Paiva WS. Invasive and Noninvasive Techniques for Intracranial Pressure Monitoring After Decompressive Craniectomy: A Systematic Review and Meta-Analysis. World Neurosurg. 2024 Oct;190:76-87. doi: 10.1016/j.wneu.2024.06.118. Epub 2024 Jun 29.
- Background: PubMed 38351298Martinez-Palacios K, Vasquez-Garcia S, Fariyike OA, Robba C, Rubiano AM; noninvasive intracranial pressure monitoring international consensus group. Quantitative Pupillometry for Intracranial Pressure (ICP) Monitoring in Traumatic Brain Injury: A Scoping Review. Neurocrit Care. 2024 Aug;41(1):255-271. doi: 10.1007/s12028-023-01927-7. Epub 2024 Feb 13.
- Background: PubMed 38114797Martinez-Palacios K, Vasquez-Garcia S, Fariyike OA, Robba C, Rubiano AM; noninvasive ICP monitoring international consensus group. Using Optic Nerve Sheath Diameter for Intracranial Pressure (ICP) Monitoring in Traumatic Brain Injury: A Scoping Review. Neurocrit Care. 2024 Jun;40(3):1193-1212. doi: 10.1007/s12028-023-01884-1. Epub 2023 Dec 19.
- Background: PubMed 37861291Martinez-Palacios K, Vasquez-Garcia S, Fariyike OA, Robba C, Rubiano AM. Non-Invasive Methods for Intracranial Pressure Monitoring in Traumatic Brain Injury Using Transcranial Doppler: A Scoping Review. J Neurotrauma. 2024 Jun;41(11-12):1282-1298. doi: 10.1089/neu.2023.0001. Epub 2024 Apr 11.
- Background: PubMed 37038236Godoy DA, Brasil S, Iaccarino C, Paiva W, Rubiano AM. The intracranial compartmental syndrome: a proposed model for acute brain injury monitoring and management. Crit Care. 2023 Apr 10;27(1):137. doi: 10.1186/s13054-023-04427-4.
- Background: PubMed 35058406Rubiano AM, Figaji A, Hawryluk GW. Intracranial pressure management: moving beyond guidelines. Curr Opin Crit Care. 2022 Apr 1;28(2):101-110. doi: 10.1097/MCC.0000000000000920.
- Background: PubMed 33738561Mohan M, Layard Horsfall H, Solla DJF, Robertson FC, Adeleye AO, Teklemariam TL, Khan MM, Servadei F, Khan T, Karekezi C, Rubiano AM, Hutchinson PJ, Paiva WS, Kolias AG, Devi BI; NIHR Global Health Research Group on Neurotrauma. Decompressive craniotomy: an international survey of practice. Acta Neurochir (Wien). 2021 May;163(5):1415-1422. doi: 10.1007/s00701-021-04783-6. Epub 2021 Mar 18.
- Background: PubMed 33354733Iaccarino C, Kolias A, Adelson PD, Rubiano AM, Viaroli E, Buki A, Cinalli G, Fountas K, Khan T, Signoretti S, Waran V, Adeleye AO, Amorim R, Bertuccio A, Cama A, Chesnut RM, De Bonis P, Estraneo A, Figaji A, Florian SI, Formisano R, Frassanito P, Gatos C, Germano A, Giussani C, Hossain I, Kasprzak P, La Porta F, Lindner D, Maas AIR, Paiva W, Palma P, Park KB, Peretta P, Pompucci A, Posti J, Sengupta SK, Sinha A, Sinha V, Stefini R, Talamonti G, Tasiou A, Zona G, Zucchelli M, Hutchinson PJ, Servadei F. Consensus statement from the international consensus meeting on post-traumatic cranioplasty. Acta Neurochir (Wien). 2021 Feb;163(2):423-440. doi: 10.1007/s00701-020-04663-5. Epub 2020 Dec 22.
- Background: PubMed 32761068Hawryluk GWJ, Rubiano AM, Totten AM, O'Reilly C, Ullman JS, Bratton SL, Chesnut R, Harris OA, Kissoon N, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Lumba-Brown A, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury: 2020 Update of the Decompressive Craniectomy Recommendations. Neurosurgery. 2020 Sep 1;87(3):427-434. doi: 10.1093/neuros/nyaa278.
- Background: PubMed 31712994Layard Horsfall H, Mohan M, Devi BI, Adeleye AO, Shukla DP, Bhat D, Khan M, Clark DJ, Chari A, Servadei F, Khan T, Rubiano AM, Hutchinson PJ, Kolias AG. Hinge/floating craniotomy as an alternative technique for cerebral decompression: a scoping review. Neurosurg Rev. 2020 Dec;43(6):1493-1507. doi: 10.1007/s10143-019-01180-7. Epub 2019 Nov 11.
- Study Web SiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The datasets generated during and/or analyzed during the current study will be available upon request to the key personnel of the sponsor institution. Individual participant data (IPD) will be stored in a private repository and made available upon request. Once requested, the unprocessed data collected on the RedCap platform will be shared as soon as possible. The shared data will be anonymous, as the only identifier will be the ID assigned to patients participating in the study. No additional consents are required for sharing IPD, as this possibility is included in the informed consent.
Related trials for Traumatic Brain Injuries
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andres M Rubiano, MD principal investigator
Meditech Foundation
Luigi V Berra, MD principal investigator
La Sapienza University
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injuries and Intracranial Hypertension, run by Meditech Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Santiago Cardona, MD (+576023720672, cardona.santiago.meditechf@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GOSE (time frame: Glasgow Outcome Scale Extended in different periods during one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06776614, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.