RecruitingObservational

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

This research is investigating treatments for serious head injuries that cause dangerous pressure inside the skull. Doctors will compare two methods of a procedure called ventriculostomy. This involves placing a small tube (catheter) into the brain to drain fluid and reduce pressure. One method uses the standard procedure, and the other uses a special locking device to keep the tube securely in place. The study wants to see if the locking device can reduce problems like infections or the tube moving, and ultimately improve a patient's recovery. It's for adults aged 18 to 70 with a specific type of head injury, and their progress will be followed for up to a year.

At a glance

Status

Recruiting

Sponsor

Meditech Foundation

Enrolment target

292

Start

30 Apr 2025

Estimated completion

01 Feb 2027

Intracranial compartment syndrome in traumatic brain injury patients

What is this study about?

This study is about a very serious condition called a traumatic brain injury (TBI), which is a bump, blow, jolt, or penetrating injury to the head that disrupts the normal function of the brain. Sometimes, these injuries can lead to increased pressure inside the skull, which can be very dangerous and even life-threatening. When this happens, doctors often perform a procedure called a ventriculostomy. This involves carefully putting a small, thin tube, called a catheter, into the brain to drain away excess fluid and relieve the pressure.

The main goal of this research is to find out if there's a better and safer way to perform this important procedure. The study will compare the standard ventriculostomy method with a modified version that uses an extra device called a catheter locking system. This locking system is designed to hold the catheter more securely in place, hopefully preventing problems like the tube moving out of position, which can lead to complications or even the need for more surgery. By comparing these two methods, the researchers hope to make the procedure more reliable and improve how well people recover from these severe injuries.

Ultimately, this research aims to improve the treatment for people who have experienced a severe traumatic brain injury and are suffering from high pressure inside their head due to a condition called intracranial compartment syndrome. If the locking device proves to be safe and effective, it could lead to better recovery and fewer complications for patients around the world.

Key takeaways

This study is testing different ways to treat high pressure in the brain after a head injury.
It compares a standard tube drainage method with one that includes a special locking device.
The aim is to make the procedure safer and improve recovery for patients.
Adults aged 18-70 with specific head injuries are eligible.
Participation involves receiving one of the two treatments and having follow-up checks for one year.
Your involvement could help improve future treatments for others.

Who may be eligible?

This study is looking for adults aged between 18 and 70 years old who have suffered a traumatic brain injury. Specifically, it's for those whose injury has caused dangerous pressure inside their head, a problem identified by scans and other tests during the first 24 hours after their injury.

To be considered for the study, your brain scan needs to show certain changes, like a shift in your brain or other signs of pressure. You also need to be expected to survive for at least 24 hours after the injury and, if surgery is needed to relieve pressure, it must happen within 24 hours of the injury.

You would not be able to join the study if more than 24 hours have passed since your injury, if your brain scan looks normal, or if you don't show the specific signs of pressure that the study is looking for. People younger than 18 or older than 70, or those with very severe injuries where survival is unlikely, also cannot take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Have you recently had a traumatic brain injury (head injury)?
Have doctors identified high pressure inside your head due to this injury?
Was your head injury diagnosed within the last 24 hours?
Are you expected to survive for at least 24 hours?
If you need pressure-relieving surgery, will it happen within 24 hours of your injury?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive one of two types of ventriculostomy procedure for your head injury: either the standard method or the standard method with an added catheter locking device. The medical team will decide which approach you receive. You will be closely monitored during your hospital stay while the catheter is in place. The catheter is usually removed between 5 to 7 days after the initial surgery.

After you leave the hospital, the study will continue to follow your progress for up to one year. This will involve regular check-ups over the phone. During these calls, the researchers will ask about your recovery and any complications you might have experienced, such as infections or if the catheter moved. The overall duration you will be involved in the study is about one year, starting from your surgery.

Potential risks and benefits

If you participate, there's a chance you might benefit from a more stable way to reduce pressure in your head, especially if you are in the group receiving the catheter locking device. You'll also receive ongoing expert medical care and close monitoring as part of the study. Your involvement could help improve future treatments for people with severe head injuries worldwide. However, like any surgical procedure, both methods carry risks such as infection, bleeding, or issues related to placing the catheter. These risks are not unique to the study. You will need to attend follow-up assessments, which will require some of your time and effort. Importantly, you have the right to withdraw from the study at any time without affecting your medical care.

Locations (34)

Hospital Universitario del Valle Evaristo García
City only
Cali, Colombia
Hospital de Kennedy
Approximate
Bogota, Colombia
Clínica Santa Gracia
Approximate
Popayan, Colombia
Clinica Abel Gonzalez
Approximate
Santo Domingo, Dominican Republic
Hospital de Emergencia Jose Casimiro Ulloa
City only
Lima, Peru
Hospital Nacional Daniel Alcides Carrion
Unverified
Callao, Peru
Hospital Belen de Trujillo
Unverified
Trujillo, Peru
Hospital Miguel Pérez Carreño
Unverified
Caracas, Venezuela
Hospital Central de Maracay
Unverified
Maracay, Venezuela
Hospital Enrique Tejera
Unverified
Valencia, Venezuela
Hospital das Clínicas da FMUSP
Unverified
São Paulo, Brazil
Fundação Hospitalar Getúlio Vargas
Unverified
Manaus, Brazil

Common questions

What is a ventriculostomy?

It's a procedure where a small tube is carefully placed into the brain to drain extra fluid and reduce dangerous pressure inside the head.

What is 'intracranial compartment syndrome'?

This is a serious condition where there's too much pressure building up inside your skull, often due to a head injury.

Will I get to choose which treatment I receive?

No, the medical team will decide whether you receive the standard ventriculostomy or the one with the locking device as part of the study.

How long will I be followed up after leaving the hospital?

The study will follow your progress for up to one year after your surgery, mainly through phone calls.

Who is paying for this study?

The study is being funded by NTPlast S.r.l., a company based in Italy.

How to find out more

Santiago Cardona

cardona.santiago.meditechf@outlook.com + 57 324 59 31186 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.