Security and effectiveness assessment of locking systems in ventriculostomy for traumatic brain injury
| ISRCTN | ISRCTN18208768 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18208768 |
- Submission date
- 02/01/2025
- Registration date
- 03/04/2025
- Last edited
- 03/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
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).
Who can participate?
Adults aged 18 to 70 years old with confirmed ICCS caused by TBI
What does the study involve?
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.
What are the possible benefits and risks of participating?
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.
Where is the study run from?
The study is conducted across multiple international centers, including countries with both high- and low-resource settings.
When is the study starting, and how long is it expected to run for?
December 2024 to February 2027
Who is funding the study?
NTPlast S.r.l. (Italy)
Who is the main contact?
Dr Andrés M Rubiano MD, PhD(c), FACS, IFAANS, rubianoam@outlook.com, direccion@meditechhubcol.org
Contact information
Principal Investigator
Calle 7A # 44-103
Cali
760036
Colombia
 ORCID ID |
0000-0001-8931-3254 |
|---|---|
| Phone | + 57 3006154775 |
| rubianoam@outlook.com |
Scientific
Calle 7A # 44-103
Cali
760036
Colombia
| ORCID ID |
0009-0000-7106-3568 |
|---|---|
| Phone | +57 310 537 4949 |
| gonzalez.wendy.meditechf@outlook.com |
Public
Calle 7A # 44-103
cali
760036
Colombia
| Phone | + 57 324 59 31186 |
|---|---|
| cardona.santiago.meditechf@outlook.com |
Scientific
Calle 7A # 44-103
Cali
760036
Colombia
| Phone | +57 310 537 4949 |
|---|---|
| proyectos@meditechhubcol.org |
Principal Investigator
Calle 7a #44-103
Cali
760036
Colombia
| Phone | +57 313 251 4132 |
|---|---|
| direccion@meditechhubcol.org |
Study information
| Study design | Prospective multicentric observational comparative-effectiveness study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Comparative-effectiveness study |
| Study setting(s) | Hospital, Medical and other records, Telephone |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Comparative effectiveness study on catheter locking device versus standard ventriculostomy for surgical management of traumatic brain injury patients with intracranial compartment syndrome |
| Study acronym | SEALS-TBI |
| Study objectives | The objective of this study is to determine the outcomes of standard ventriculostomy versus the use of a locking system for the ventricular catheter in the surgical management of patients with TBI and intracranial compartment syndrome. |
| Ethics approval(s) |
Approved 31/01/2025, Meditech Ethics and Research Committee (Calle 7A # 44-103, Cali, 760036, Colombia; +57 602 372 06 72; comitedeeticainvestigacion@meditechhubcol.org), ref: CEIM-2024-12-101 |
| Health condition(s) or problem(s) studied | Intracranial compartment syndrome in traumatic brain injury patients |
| Intervention | 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. Methodological Description: Enrollment: Participants are screened upon admission to the emergency room after experiencing a traumatic brain injury (TBI). Eligibility is determined using clinical and imaging criteria, including abnormal brain CT scans and evidence of intracranial compartment syndrome (ICCS), which is defined as a primary intracranial injury generating loss of intracranial compliance and generating risk for brain tissue hypoxia and/or hypoperfusion. Informed consent is obtained from participants or their legal representatives as many of these patients can arrive with a low level of consciousness due to the TBI. Surgical Intervention: Participants are assigned to one of two groups: Standard Ventriculostomy: Involves inserting a catheter into the brain’s ventricular system to drain cerebrospinal fluid (CSF) and reduce intracranial pressure (ICP). This is a common procedure performed in this type of patient. Do not include a novel technique. Ventriculostomy with a Locking Device: This intervention is the same procedure, but it will be performed with an additional approved device, a locking system that secures the catheter in place, reducing the risk of displacement and associated complications. The system requires internal approval by regulatory entities in each of the participant countries. Most of them already have approval and the others are in an internal approval process. Countries cannot start collecting data until they have the internal government approval for the device distribution by internal medical suppliers. Follow-Up and Monitoring: Observation During Hospitalization: Patients with this type of procedure always go for postoperative management to intensive care units (ICUs), independent of the study. Follow-up is performed by ICU personnel and includes systemic multimonitoring and they evaluate catheter functionality, and complications such as infections or displacement. They regularly require head imaging control with CT not specifically associated with the study (is an observational CEI study). The data collectors of the study will be collecting physiological variables and descriptions of catheter integrity on a daily basis from the clinical records of the ICU. The follow-up will include the first two weeks after surgery, but in general, these types of catheters do not remain in place for more than 8 days. Regularly they are taken out by the neurosurgery service between 5 to 7 days after insertion. Data monitoring will be performed by the central research team in permanent contact with the local investigators. Long-Term Follow-Up: Data will be collected from the medical record until discharge or transfer of the patient and by telephone interview at 3, 6, and 12 months after the admission. The telephone follow-up will include the application of the Glasgow Outcome Scale - Extended version (GOSE), and evaluations of functional recovery. Duration: Total Observation: Participants will be observed continuously during their hospital stay. Data Collection and Sources: Data will be collected from the medical records. Demographic and Clinical Data: Includes age, sex, baseline health, and mechanism of trauma. Surgical Outcomes: Will include the catheter placement, patency and complications if any reported in the medical record or observed inside the ICU. Functional Outcomes: Evaluated from the medical records and GOSE scores. Data Sources: Data will be collected from medical records, direct observations, and after discharge by telephone interviews conducted by trained personnel. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Functional outcomes measured using the Glasgow Outcome Scale Extended at discharge, 3 months, 6 months, and 12 months after surgery |
| Secondary outcome measures | 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 |
| Overall study start date | 27/12/2024 |
| Completion date | 28/02/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 292 |
| Key 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 < 20 cm/seg on the same side of the CT´s primary injury or/and a P2>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 |
| Key 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 6. Cranial decompression or cranial expansion surgical procedures performed >24 hours after the trauma |
| Date of first enrolment | 30/04/2025 |
| Date of final enrolment | 01/02/2027 |
Locations
Countries of recruitment
- 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
Study participating centres
Cali
760042
Colombia
Bogota
110871
Colombia
Popayan
190003
Colombia
Santo Domingo
10109
Dominican Republic
Lima
150122
Peru
Callao
07001
Peru
Trujillo
13001
Peru
Caracas
1020
Venezuela
Maracay
2101
Venezuela
Valencia
2001
Venezuela
São Paulo
05403-900
Brazil
Manaus
69020
Brazil
La Paz
0000
Bolivia
Tarija
0000
Bolivia
Santiago de chile
4848
Chile
Los Lagos
5480000
Chile
Ciudad de Guatemala
01010
Guatemala
Ciudad de Guatemala
01011
Guatemala
Asunción
1500
Paraguay
Quito
170403
Ecuador
Quito
170515
Ecuador
Ambato
180104
Ecuador
Manta
130213
Ecuador
Ibadan
200212
Nigeria
Kigali
250
Rwanda
Garoua
237
Cameroon
Cairo
11562
Egypt
Dar es Salaam
141111
Tanzania
Daraga
4501
Philippines
Penh
12000
Cambodia
Khon Kaen
40000
Thailand
Rome
0649971
Italy
Belgrado
11000
Serbia
Riohacha
440001
Colombia
Sponsor information
Research organisation
Calle 7A # 44-103
Cali
760036
Colombia
| Phone | +57 317 392 62 09 |
|---|---|
| asistenciafundacionmeditech@gmail.com | |
| Website | https://www.meditechfoundationglobal.org/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 28/02/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from MS Dr Wendy Gonzalez (gonzalez.wendy.meditecf@outlook.com). Participant-level data (IPD) collected during the study will be securely stored in a private repository managed using institutional REDCap software based on our internal server. The server and the repository are not publicly accessible, ensuring the confidentiality and protection of participant information. The data will be organized and maintained according to strict data management protocols, including anonymization procedures to remove personally identifiable information. Access to the repository will be limited to authorized personnel involved in the study, and all data usage will comply with ethical and legal standards. Additional details about data sharing, including the timing of availability and any restrictions, will be included in the study record once finalized. Databases for the study will be available upon request to any of our standard channels of communication. |
Editorial Notes
14/02/2025: Study's existence confirmed by the Institutional Review Board (IRB) of the
MEDITECH Foundation.
