Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Wendy Gonzalez
proyectos@meditechhubcol.org


Mr Santiago Cardona
cardona.santiago.meditechf@outlook.com


Dr Andrés M Rubiano
rubianoam@outlook.com


Ms Wendy Gonzalez
gonzalez.wendy.meditechf@outlook.com


Dr Andrés M Rubiano
direccion@meditechhubcol.org


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - Security and effectiveness assessment of locking systems in ventriculostomy for traumatic brain injury

Security and effectiveness assessment of locking systems in ventriculostomy for traumatic brain injury

Medical Conditions

Intracranial compartment syndrome in traumatic brain injury patients


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This study focuses on traumatic brain injuries (TBI), a condition that can cause severe intracranial pressure and life-threatening complications. This study aims to compare the effectiveness and safety of a standard intervention called ventriculostomy for managing increased intracranial pressure (ICP) in patients with severe traumatic brain injury (TBI). Elevated ICP is a critical condition that can result in brain damage or death if not treated promptly. The goal is to reduce complications like catheter displacement and improve outcomes for patients with intracranial compartment syndrome (ICCS).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

30 Apr 2025 01 Feb 2027

The intervention will be performed in a traditional standard way or with an additional device called a catheter locking system. The first approach, standard ventriculostomy, involves placing a catheter into the brain’s ventricular system to drain cerebrospinal fluid (CSF), thereby reducing ICP. The second approach incorporates the same catheter plus a catheter-locking device designed to secure the catheter in place, potentially reducing complications such as catheter displacement and the need for additional surgeries. Participants in this study will undergo either standard ventriculostomy or ventriculostomy with the locking device. Their progress will be observed during their hospital stay until the catheter is taken out (regularly on days 5th to 7th after the initial surgery) and assessed over the course of 1 year through structured telephone follow-ups. The main outcomes include functional recovery and the rate of complications such as operative site infections, catheter displacement, and/or reinterventions. By comparing these two methods, the study seeks to determine whether the locking device improves outcomes for TBI patients while maintaining or enhancing the safety and reliability of the procedure.


Adults aged 18 to 70 years old with confirmed ICCS caused by TBI

You can take part if:



You may not be able to take part if:


1. TBI patients arriving at the emergency room after 24 hours following trauma2. Normal CT scan at the emergency room3. 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 analyzer4. Age less than 18 or more than 70 years old5. Polytrauma or massive brain injury with survival expectancy <24 hours6. Cranial decompression or cranial expansion surgical procedures performed >24 hours after the trauma


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Hospital Universitario del Valle Evaristo García
    Calle 5 ·#36-08
    Cali
    760042
  • Hospital de Kennedy
    Carrera 78 #41A-85 Sur
    Bogota
    110871
  • Clínica Santa Gracia
    Calle 14 Norte #9-15
    Popayan
    190003
  • Clinica Abel Gonzalez
    Avenida Independencia #101
    Santo Domingo
    10109
  • Hospital de Emergencia Jose Casimiro Ulloa
    Av. Roosevelt 6355
    Lima
    150122
  • Hospital Nacional Daniel Alcides Carrion
    Av. Guardia Chalaca 2176
    Callao
    07001
  • Hospital Belen de Trujillo
    Jiron Bolivar 350
    Trujillo
    13001
  • Hospital Miguel Pérez Carreño
    Av. San Martín, a la altura de Maternidad
    Caracas
    1020
  • Hospital Central de Maracay
    Av. Las Delicias, Maracay
    Maracay
    2101
  • Hospital Enrique Tejera
    Av. Lisandro Alvarado
    Valencia
    2001
  • Hospital das Clínicas da FMUSP
    Av. Dr. Enéas de Carvalho Aguiar, 255
    São Paulo
    05403-900
  • Fundação Hospitalar Getúlio Vargas
    Avenida Apurinã, número 4, en el barrio Praça 14 de Janeiro
    Manaus
    69020
  • Hospital Obrero No. 1
    Calle Lucas Jaimes 76
    La Paz
    0000
  • Hospital Regional San Juan de Dios
    Calle Santa Cruz
    Tarija
    0000
  • Hospital Clínico Mutual de Seguridad
    Av. Libertador Bernardo O'Higgins
    Santiago de chile
    4848
  • Hospital Puerto Montt
    Los Aromos 65, Puerto Montt
    Los Lagos
    5480000
  • Hospital General San Juan de Dios
    1ra Avenida "A" 10-50
    Ciudad de Guatemala
    01010
  • Hospital Roosevelt
    Calzada Roosevelt
    Ciudad de Guatemala
    01011
  • Hospital del Trauma Prof. Dr. Manuel Giagni
    Av Gral Máximo Santos
    Asunción
    1500
  • Hospital de Especialidades Eugenio Espejo
    Av. Gran Colombia
    Quito
    170403
  • Hospital General Monte Sinai
    Av. Gran Colombia
    Quito
    170515
  • Hospital General Docente Ambato
    Av. Pasteur y Unidad Nacional
    Ambato
    180104
  • Hospital General Rodríguez Zambrano
    Barrio Sta. Martha Calle 12 V-A San Mateo
    Manta
    130213
  • University College Hospital
    Queen Elizabeth Road, Ibadan, Oyo State
    Ibadan
    200212
  • Rwanda Military Hospital
    Street KK739ST, Kanombe, Distrito de Kicukiro
    Kigali
    250
  • Garoua Regional Teaching Hospital
    Boulevard Docteur Jamot, Garoua, Región Norte
    Garoua
    237
  • El Qasr El Ainy Hospital
    27 Nafezet Sheem El Shafaey St, Kasr Al Ainy
    Cairo
    11562
  • Muhimbili Orthopaedic Hospital
    Kalenga Street, West Upanga,
    Dar es Salaam
    141111
  • Bicol Regional Hospital and Medical Center
    Rizal St. 4501
    Daraga
    4501
  • Techo Santepheap National Hospital
    JRC6+JR Win Win Blvd, Phnom
    Penh
    12000
  • Khon Kaen Hospital
    54 Sri Chant Rd, Nai Mueang, Mueang Khon Kaen District
    Khon Kaen
    40000
  • Azienda Ospedaliero-Universitaria Policlinico Umberto I
    Viale del Policlinico, 155, 00161 Roma RM, Italia
    Rome
    0649971
  • Neurosurgical Clinic University Clinical Centre of Serbia
    Dr Koste Todorovića 4, Beograd
    Belgrado
    11000
  • Centro Diagnóstico de Especialistas Ltda
    Calle 13 No. 11-75, Riohacha, Guajira
    Riohacha
    440001

Participants may benefit from a more stable and effective method of reducing ICP, especially if they are assigned to the locking device group. The study provides access to expert surgical care and close monitoring throughout the recovery process. Contributions to this research could lead to improved treatment protocols for future TBI patients worldwide.
Both procedures carry inherent surgical risks, including infection, bleeding, or complications related to catheter placement and not to the study per se. Because the indications for any of the two interventions will be the same for the original procedure at the discretion of the neurosurgeon on call. Participants will be required to attend follow-up assessments, which may involve some time and effort. All procedures will be performed by experienced neurosurgeons following established safety protocols. Participants will be closely monitored, and any complications will be promptly addressed. This study represents an important step toward advancing surgical techniques for managing severe TBI and improving the quality of care for patients worldwide.

Dr Andrés M Rubiano
direccion@meditechhubcol.org


Dr Andrés M Rubiano
rubianoam@outlook.com


Ms Wendy Gonzalez
proyectos@meditechhubcol.org


Ms Wendy Gonzalez
gonzalez.wendy.meditechf@outlook.com


Mr Santiago Cardona
cardona.santiago.meditechf@outlook.com



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Meditech Foundation and funded by NTPlast.




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Read full details for Trial ID: ISRCTN18208768
Last updated 03 April 2025

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