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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.
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 SurgicelĀ® or GelfoamĀ®.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decompressive Craniectomy Group | Patients with early emergency room (ER) diagnosis of intracranial compartment syndrome who underwent a classical hemicranial decompressive craniectomy procedure |
| |
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decompressive Craniectomy | Procedure | 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 SurgicelĀ® or GelfoamĀ®. 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. |
| Measure | Description | Time Frame |
|---|---|---|
| GOSE | Standard GOSE Evaluation without dichotomization. | Glasgow Outcome Scale Extended in different periods during one year |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Site Complications | Post-operative CSF disturbances, surgical site infection, wound complications, number of required re-interventions. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Compliance Preservation | Control of the Intracranial Compartment Syndrome measured using ICP waveform via invasive and noninvasive devices and/or noninvasive neuromonitoring techniques (digital pupillometry, optic nerve sheath diameter ultrasonographic measurement, and transcranial Doppler) measured daily since ICU admission | 15 days |
Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Santiago Cardona, MD | Contact | +576023720672 | cardona.santiago.meditechf@outlook.com | |
| Wendy Gonzalez, MD | Contact | +576023720672 | gonzalez.wendy.meditechf@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Andres M Rubiano, MD | Meditech Foundation | Principal Investigator |
| Luigi V Berra, MD | La Sapienza University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36701747 | Background | 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. | |
| 39294706 |
| Label | URL |
|---|---|
| Study Web Site | View source |
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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.
From June 2025 to June 2027
The datasets generated during and/or analyzed during the current study will be available upon request to the key personnel of the sponsor institution (see contact information). 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.
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D019586 | Intracranial Hypertension |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Not provided
| ID | Term |
|---|---|
| D056424 | Decompressive Craniectomy |
| ID | Term |
|---|---|
| D019299 | Decompression, Surgical |
| D013514 | Surgical Procedures, Operative |
| D003399 | Craniotomy |
| D019635 | Neurosurgical Procedures |
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Not provided
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|
|
| Expansion Craniotomy | Procedure | 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 SurgicelĀ® or GelfoamĀ®. 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. |
|
|
| Hospital Lenght of stay |
ICU and in-hospital length of stay collected from medical records at hospital discharge |
| 1 year |
| Godoy 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. |
| 38950649 | Background | Palavani 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. |
| 38351298 | Background | Martinez-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. |
| 38114797 | Background | Martinez-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. |
| 37861291 | Background | Martinez-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. |
| 37038236 | Background | Godoy 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. |
| 35058406 | Background | Rubiano 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. |
| 33738561 | Background | Mohan 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. |
| 33354733 | Background | Iaccarino 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. |
| 32761068 | Background | Hawryluk 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. |
| 31712994 | Background | Layard 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. |
| 31134383 | Background | Hutchinson 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. |
| 30863354 | Background | Clavijo 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. |
| 30659971 | Background | Rubiano 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. |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |