RecruitingNAINTERVENTIONAL

Incidence, Characteristics and Evolution of Cerebral Vasospasm With Clinical Impact in Moderate to Severe Traumatic Brain Injury Complicated by Subarachnoid Hemorrhage at Martinique University Hospital

This study at Martinique University Hospital is investigating a condition called cerebral vasospasm. This happens when blood vessels in the brain narrow after a serious head injury complicated by bleeding around the brain. While this complication is well-known in other types of brain bleeds, it's less understood after head injuries. Researchers want to find out how often this vasospasm occurs in patients with moderate to severe head injuries, what its characteristics are, and how it develops over time. They will use a special type of brain scan to help diagnose it more accurately. The aim is to better understand this problem, as it can affect a patient's recovery and long-term health, helping doctors provide better care. This is an observational study, meaning patients will receive standard care, and researchers will gather information.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital Center of Martinique

Enrolment target

154

Start

06 Nov 2024

Estimated completion

06 Dec 2028

SAH (Subarachnoid Hemorrhage)Cerebral Vasospasm Moderate Traumatic Brain Injury Severe Traumatic Brain Injury

What is this study about?

When someone has a moderate to severe head injury, especially if there's bleeding around the brain (a condition called subarachnoid hemorrhage or SAH), there's a risk of another problem called cerebral vasospasm. This means the blood vessels in the brain can narrow, which might reduce blood flow and potentially harm the brain. While doctors know a lot about vasospasm when it's caused by other types of brain bleeding, there isn't as much information about it after a head injury.

This study in Martinique aims to learn more about cerebral vasospasm following moderate to severe head injuries. The researchers want to understand how often it happens, what its typical features are, and how it progresses in patients. They believe that by getting a clearer picture of this complication, doctors can recognise it sooner and potentially improve patient outcomes. They are particularly interested in using a special type of CT brain scan that can show blood flow, which they think will be better at detecting vasospasm than current methods.

Ultimately, this research hopes to provide valuable information about how this specific complication affects patients after a head injury. By understanding its patterns and impact, the doctors at Martinique University Hospital hope to improve future care for people recovering from these types of serious brain injuries.

Key takeaways

This study is about understanding how brain blood vessels narrow after serious head injuries.
It's an observational study, meaning you get standard medical care, but information is collected.
A special brain scan (perfusion scan) might be used to help detect the problem if concerns arise.
The goal is to improve future care for patients with head injuries and brain bleeds.
Participation is voluntary, and you can withdraw at any time.
The study takes place at Martinique University Hospital.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older. You should be receiving care at Martinique University Hospital for a moderate to severe head injury, and have been found to have bleeding around your brain (subarachnoid hemorrhage) on a brain scan. It's important that you, or your legally authorised representative if you're unable, understand the study and agree to take part in writing. You also need to be part of a social security system.

There are several reasons why someone might not be able to join the study. This includes if you are pregnant, have a known brain aneurysm, or severe kidney problems. You also cannot participate if you are expected to pass away very soon, are receiving end-of-life care, or have a known allergy to the special contrast dye used in some scans. If you are under legal protection like guardianship, or if you or your representative do not wish to participate, you won't be included. Also, if you unfortunately pass away within the first 48 hours, or are transferred to another hospital soon after your injury, you would no longer be eligible.

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 18 years old or older?
Are you being treated for a moderate to severe head injury at Martinique University Hospital with bleeding around your brain?
Are you, or your representative, able to understand and agree to participate in writing?
Are you NOT pregnant and do you NOT have a brain aneurysm or severe kidney disease?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, the researchers will collect information about your health and treatment during your time at Martinique University Hospital. This is an observational study, which means you will receive the standard medical care you would otherwise get. The main additional intervention specific to the study is that some patients might have an advanced brain scan, called a brain perfusion scan, if there are concerns that your neurological condition might be worsening. This scan helps doctors see blood flow in the brain. The researchers will then track your progress and health for up to six months after your initial head injury, mainly by collecting information from your medical records. You won't be asked to visit the hospital specifically for the study once you've been discharged.

Potential risks and benefits

Participating in this study might help doctors better understand and potentially improve care for future patients with similar head injuries. For you, the main potential benefit is that the study might lead to a more detailed scan (brain perfusion scan) if your doctors suspect a complication, potentially helping with diagnosis. The risks involved are minimal since you'll be receiving standard care. The additional brain scan uses a small amount of radiation, similar to other CT scans, and a contrast dye which some people can be allergic to (though this is checked beforehand). Remember, agreeing to join is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospital Center of Martinique
City only
Fort-de-France, France· Recruiting

Common questions

What is 'cerebral vasospasm'?

It's when blood vessels in your brain narrow after a brain bleed or injury, which can reduce blood flow.

Is this study giving me new medicine?

No, this study is observational. You'll receive your usual medical care, and researchers will collect information.

What is a 'brain perfusion scan'?

It's a special type of brain scan that helps doctors see blood flow in different parts of your brain.

How long will the study follow me?

The study will track your health information for up to six months after your head injury.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, and it won't affect your medical care.

How to find out more

Marie SABIA, PhD

marie.sabia@chu-martinique.fr 05 96 55 10 54 Official trial record

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