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Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1) to Exclude Lesions Linked to Significant Traumatic Brain Injuries

This research study aims to find out if a combination of two specific markers found in a blood sample (UCH-L1 and GFAP) can accurately tell if someone with a mild head injury, who arrives at the emergency department within 12 hours, does NOT have a serious brain injury that would show up on a CT scan. The idea is to make sure people get the right care quickly, and potentially reduce the number of CT scans if they're not needed. Participants will have an extra blood sample taken during their routine care, and a phone call follow-up seven days after leaving the hospital. This study is for people aged 18 and over who have had a mild head injury, and it's taking place in emergency departments in France and Monaco. It won't change your usual medical treatment.

At a glance

Status
Recruiting
Sponsor
Centre Hospitalier Princesse Grace
Enrolment target
1,500
Start
19 Apr 2024
Estimated completion
30 Mar 2026

What is this study about?

When you have a head injury, especially a mild one, doctors sometimes need to do a special scan called a CT scan of your brain to check for serious damage. While CT scans are very helpful, they expose you to a small amount of radiation, and sometimes they show nothing concerning. This study is looking into a new way to help doctors decide if a CT scan is really necessary for people with a mild head injury.

The researchers are focusing on two natural substances found in your blood called UCH-L1 and GFAP. When your brain is injured, these substances can be released into your bloodstream. The main goal of this study is to see if measuring both UCH-L1 and GFAP together in a blood sample can reliably show that there is no major brain injury that would be picked up by a CT scan.

By figuring this out, doctors might be able to use a blood test to help them make better, quicker decisions about who needs a CT scan and who doesn't. This could mean fewer unnecessary CT scans for some people, while still making sure that everyone with a potentially serious injury gets the proper care.

Key takeaways

  • Study aims to use blood tests (UCH-L1, GFAP) to help decide if a CT scan is needed after a mild head injury.
  • Participation involves one extra blood sample during routine blood tests and a phone call follow-up 7 days later.
  • Your medical treatment for your head injury will NOT be changed by taking part in the study.
  • The study is for adults (18+) who have recently had a mild head injury and meet specific criteria.
  • Your blood sample needs to be taken within 12 hours of your head injury.
  • You can stop participating at any time without affecting your medical care.

Who may be eligible?

This study is looking for adults aged 18 and over who have recently had a mild head injury. To be potentially included, your head injury must have involved either a hit to the head or face, or a sudden jolt, and your alertness level (measured by something called a Glasgow Coma Scale) should be 13, 14, or 15. You also need to have at least one of these situations: you're over 65 and taking blood thinners for your heart; your alertness level dropped two hours after the injury AND you had alcohol or drugs in your system; your injury happened from a forceful event like being hit by a car or falling from a height; or you can't remember more than 30 minutes before the injury.

For the blood test to be useful for the study, your blood sample needs to be taken within 12 hours of your injury, and your doctor must have already planned for you to have a CT scan as part of your usual care. You also need to be able to understand and sign a consent form to join the study.

You won't be able to join if you don't have health insurance, are under legal protection, or your blood sample is taken more than 12 hours after your injury. You'll also be excluded if your doctor already knows you definitely need a CT scan because of certain other problems, such as if your alertness level is very low (below 13), you have a bleeding disorder, show signs of a skull fracture, have vomited many times, had a seizure after the injury, or have new weakness or numbness. Finally, if it would be difficult for the researchers to follow up with you a week later, you wouldn't be able to participate.

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.

  1. Are you 18 years old or older?
  2. Have you recently had a head injury (within the last 12 hours)?
  3. Did your head injury involve a hit to the head/face or a sudden jolt?
  4. Are you currently scheduled to have a CT scan for your head injury?
  5. Are you over 65 and taking anti-clotting medication, OR did your alertness drop 2 hours after injury with alcohol/drug use, OR was your injury from a high-force event, OR can you not remember things from 30+ minutes before the injury?
  6. Do you feel well enough to talk on the phone in about a week?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue to receive all your usual medical care and treatment in the emergency department, exactly as your doctors would recommend. There will be two extra parts to your participation:

1. **Extra Blood Sample:** When the nurses take blood for your routine tests, they will take a tiny bit more at the same time for the study. This won't involve any extra needle sticks. 2. **Follow-up Phone Call:** About seven days after you leave the hospital, a member of the research team will call you for a brief chat. This call is to check how you are doing and gather a little more information about your recovery.

Your involvement will not change the treatment you receive, and the study will only add these two simple steps to your existing care plan. The total duration of your participation, from the blood test to the follow-up call, will be about seven days.

Potential risks and benefits

Taking part in this study might help improve how doctors care for people with head injuries in the future, potentially leading to fewer unnecessary brain scans. There are no direct medical benefits for you personally from the study, as it won't change your current treatment. The main risk is the tiny, usual discomfort from having a blood sample taken, which is already part of your planned care. You are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (15)

  • Centre Hospitalier Universitaire d'Angers
    Verified postcode
    Angers, France· Recruiting
  • Hôpital Gabriel-Montpied - CHU de Clermont-Ferrand
    Verified postcode
    Clermont-Ferrand, France· Recruiting
  • Hôpital François Mitterrand - CHU de Dijon
    Verified postcode
    Dijon, France· Recruiting
  • Hôpital Nord - CHU de Grenoble-Alpes
    Verified postcode
    Grenoble, France· Recruiting
  • Hospices Civils de Lyon
    Verified postcode
    Lyon, France· Recruiting
  • Hôpital Lapeyronie - CHU de Montpellier
    Verified postcode
    Montpellier, France· Not yet recruiting
  • Hôtel Dieu - CHU de Nantes
    Verified postcode
    Nantes, France· Recruiting
  • Hôpital Pasteur CHU de Nice
    Verified postcode
    Nice, France· Recruiting
  • Hôpital Carémeau - CHU de Nîmes
    Verified postcode
    Nîmes, France· Recruiting
  • AP-HP Nord Lariboisière
    Verified postcode
    Paris, France· Recruiting
  • AP-HP Sorbonne Université, site Pitié-Salpêtrière
    Verified postcode
    Paris, France· Recruiting
  • Hôpital Saint-Joseph
    Verified postcode
    Paris, France· Recruiting

Common questions

What is a 'mild traumatic brain injury'?

It's another name for a mild head injury. It means you've had a bump or jolt to the head, but you're generally still quite alert, even if you feel a bit confused or have a headache.

What are UCH-L1 and GFAP?

These are natural substances in your body that can be found in your blood when your brain has been injured. Doctors want to see if measuring them can help understand your injury better.

Will this study change my treatment?

No, absolutely not. You will receive the same medical care from your doctors as if you were not in the study. Your participation only adds an extra blood sample and a phone call.

Do I have to get a CT scan if I join?

Whether you need a CT scan is a decision your emergency doctor will make based on your condition and usual medical guidelines. This study is trying to find out if blood tests could one day help make these decisions, but it doesn't immediately change what your doctor plans for you.

Where is this study happening?

This study is taking place in emergency departments in France and Monaco, specifically at the Nice University Hospital Center for one part of the study.

How to find out more

Yann-Erick CLAESSENS, MD-PhD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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