RecruitingOBSERVATIONAL

Thrombo-inflammation Biomarkers Trial in Acute Cerebral Hypoxia

This study aims to understand how brain conditions caused by a lack of oxygen, like severe stroke or bleeding in the brain, affect the body's response. We're looking at special markers in the blood related to clotting and inflammation (the body's healing process). The researchers will compare these markers in people with serious brain issues to those who have had a mini-stroke (TIA). The main goal is to see if these blood markers can predict how well someone might recover after a severe brain event. Ultimately, this research hopes to improve how we understand and care for people experiencing these types of brain injuries.

At a glance

Status

Recruiting

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Enrolment target

200

Start

19 Mar 2024

Estimated completion

22 Jun 2026

Cerebral Hypoxia Ischemic Stroke

What is this study about?

This research study is looking into what happens in the body when the brain doesn't get enough oxygen. This can happen in several serious health situations, such as a severe stroke, bleeding around the brain (called a subarachnoid haemorrhage), or a large bleed within the brain itself (an intra-parenchymal haematoma). In these conditions, there's often something called 'thrombo-inflammation', which means there's both a problem with blood clotting and the body's natural response to injury (inflammation) happening at the same time.

The scientists want to measure specific substances in the blood, called 'biomarkers', that are linked to this thrombo-inflammation. They are comparing these markers in people with these serious brain conditions to a group of people who have had a 'mini-stroke', also known as a Transient Ischemic Attack (TIA). A TIA is a temporary problem with blood flow to the brain that usually doesn't cause lasting damage.

By comparing these groups, the researchers hope to understand if the levels of these blood markers are different in people with severe brain injuries. More importantly, they want to see if the levels of these markers can tell us something about how well a person with a severe brain injury might recover. This knowledge could one day help doctors better understand and treat people affected by these conditions.

Key takeaways

This study investigates blood markers in people with serious brain conditions.
It aims to understand how brain injuries due to lack of oxygen affect the body.
Researchers hope to link these blood markers to how well patients recover.
Taking part involves simple blood samples and no new medications.
Your contribution could help improve how future brain injuries are understood and treated.

Who may be eligible?

To be part of this study, you would typically be admitted to the hospital within 36 hours of having sudden brain symptoms. This applies if you've had a severe stroke that might need a clot removed, a serious bleed around the brain (subarachnoid haemorrhage), or a large bleed inside the brain itself (intra-parenchymal haematoma). Your condition would need to meet certain severity criteria to be considered.

Alternatively, you might be eligible to join as a 'control' participant if you've been admitted within 7 days of having a mini-stroke (TIA). For this, your TIA would need to be diagnosed based on specific questions and a certain risk score, and you must not show any abnormalities on brain scans taken later. All participants need to agree to take part and be covered by social security.

However, some people cannot participate. This includes if you already have significant problems with daily activities or thinking, are under legal protection, or are pregnant or breastfeeding. Also, if your stroke is not a specific type that needs mechanical clot removal, or if you have a different kind of brain problem like migraine or epilepsy, you wouldn't be able to join. TIA patients who later show signs of damage on brain scans would also be excluded.

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.

Have I recently experienced a severe stroke, brain haemorrhage, or similar serious brain event?
Or, have I recently had a mini-stroke (TIA) and not had any lasting brain damage on scans?
Am I over 18 years old?
Am I NOT pregnant or breastfeeding?
Do I NOT have a pre-existing severe disability or thinking problems?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will have blood samples collected. The research team will be looking at specific markers in your blood. These samples will be taken shortly after you are admitted to the hospital. The study involves collecting your blood and then observing your recovery to see how it relates to the blood markers found. There is no specific medication to take as part of this study, nor are there additional doctor's visits beyond your standard medical care. The total duration of your participation will depend on how long you are in the hospital and how long the researchers track your recovery data.

Potential risks and benefits

Taking part in this study involves a very low risk, mainly from the blood samples, which is a routine procedure. You might experience minor bruising or discomfort where the blood is taken. There are no direct benefits to you from participating, as the study is about understanding diseases rather than providing new treatments. However, your involvement will contribute to valuable medical knowledge that could help future patients. You are free to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Hôpital Fondation Adolphe de Rothschild
Verified postcode
Paris, France· Recruiting

Common questions

What is 'Cerebral Hypoxia'?

It means your brain isn't getting enough oxygen, which can cause serious problems.

What are 'biomarkers'?

These are naturally occurring substances in your body, like in your blood, that can tell doctors about your health or a disease.

Is this study testing a new drug?

No, this study is about understanding diseases better by looking at blood markers; it's not testing any new medicines.

Will taking part help me directly?

This study aims to help future patients by increasing medical knowledge, rather than directly benefiting you.

Can I stop participating if I change my mind?

Yes, you can leave the study at any time without it affecting your medical care.

How to find out more

François DELVOYE

fdelvoye@for.paris 0148036556 Official trial record

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