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

NCT06776614 | Not Yet Recruiting DMC

• 1 other identifier: CEIM-2024-12-102
• Study Type: observational
• Target: 292
• Locations: 0 countries
• Sites: N/A

Brief 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, 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.

Conditions

Traumatic Brain Injuries; Intracranial Hypertension

Keywords

Traumatic Brain Injury; Intracranial Compartment Syndrome; Decompressive Craniectomy; Expansive Craniotomy

Outcome Measures

Primary Outcomes (1)

• GOSE

  Standard GOSE Evaluation without dichotomization.

  Glasgow Outcome Scale Extended in different periods during one year

Secondary Outcomes (1)

• Surgical Site Complications

  1 year

Other Outcomes (2)

• Post Operative Compliance Preservation

  15 days

• Hospital Lenght of stay

  1 year

Study Arms (2)

Decompressive Craniectomy Group

Patients with early emergency room (ER) diagnosis of intracranial compartment syndrome who underwent a classical hemicranial decompressive craniectomy procedure

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).

Procedure: Expansion Craniotomy

Interventions

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 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.

Also known as: Cranial Decompression, Hemi Craniectomy

Decompressive Craniectomy Group

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 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.

Also known as: Hinge Craniotomy

Expansion Craniotomy Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meditech Foundation: lead

Related Publications (15)

• 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.

  PMID: 36701747 BACKGROUND

• 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.

  PMID: 39294706 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.

  PMID: 38950649 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.

  PMID: 38351298 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.

  PMID: 38114797 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.

  PMID: 37861291 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.

  PMID: 37038236 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.

  PMID: 35058406 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.

  PMID: 33738561 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.

  PMID: 33354733 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.

  PMID: 32761068 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.

  PMID: 31712994 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.

  PMID: 31134383 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.

  PMID: 30863354 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.

  PMID: 30659971 BACKGROUND

Related Links

• Study Web Site

MeSH Terms

Conditions

Brain Injuries, Traumatic; Intracranial Hypertension

Interventions

Decompressive Craniectomy

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Decompression, Surgical; Surgical Procedures, Operative; Craniotomy; Neurosurgical Procedures

Study Officials

• Andres M Rubiano, MD

  Meditech Foundation

  PRINCIPAL INVESTIGATOR

• Luigi V Berra, MD

  La Sapienza University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Santiago Cardona, MD

CONTACT

+576023720672; cardona.santiago.meditechf@outlook.com

Wendy Gonzalez, MD

CONTACT

+576023720672; gonzalez.wendy.meditechf@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 15, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From June 2025 to June 2027
• Access Criteria: 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.