AuthorisedTherapeutic confirmatory (Phase III)Interventional

EFFICACY OF PROPRANOLOL IN TRAUMATIC BRAIN INJURY PATIENTS ADMITTED TO THE ICU: A PROSPECTIVE, RANDOMIZED, TRIPLE-BLIND STUDY (ProP TBI in ICU)

This research is investigating if a widely used medication, propranolol, could be helpful for patients admitted to intensive care after a head injury. The study aims to see if giving propranolol can improve a patient's chances of recovery and survival in the hospital. Participants will be randomly given either propranolol or a 'dummy' pill (which contains no active medicine). This is a 'triple-blind' study, meaning that the patients, their doctors, and the researchers won't know who is receiving the real medication. This method helps to ensure the results are as fair and accurate as possible. The main goal is to find out if propranolol can reduce the number of deaths in hospital among people with head injuries, and whether it helps with long-term recovery.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

University Hospital Son Espases

Enrolment target

600

Start

05 Feb 2026

Head injury

What is this study about?

This study, called 'ProP TBI in ICU,' is designed to look at whether a medicine called propranolol can help people who have a severe head injury and are being treated in an intensive care unit (ICU). Propranolol is a drug that's already used for many health conditions, like heart problems or high blood pressure, and it’s known to affect the body's stress response. Researchers want to see if it could also benefit patients after a serious head injury.

The main question this study is trying to answer is if propranolol can reduce the number of people who die in the hospital after a head injury. They will also be looking at how well people recover generally after their injury, using a widely accepted scale. By comparing propranolol to a 'dummy' pill (called methylcellulose), the researchers can accurately tell if any improvements are due to the real medicine or something else.

This is a 'Phase III' study, which means it's a large and important step to confirm if propranolol is effective and safe for this specific use. These types of studies are crucial before a new treatment can be widely recommended. The results will help doctors understand if propranolol could become a standard part of care for people with head injuries in the ICU.

Key takeaways

This study investigates if propranolol can improve recovery for head injury patients in intensive care.
It's a large 'Phase III' study, aiming to confirm potential benefits.
Participants will receive either propranolol or a dummy pill, with no one knowing which one.
The main goal is to see if propranolol reduces hospital deaths and improves overall recovery.
It includes adults aged 18 and over who have been admitted to ICU for a head injury.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adults who are 18 years old or older. There is no upper age limit, meaning older adults can also take part. Both men and women are welcome to participate.

The main requirement for being considered for this study is that you must have been admitted to an intensive care unit (ICU) due to a head injury. The medical team would determine if the study is right for you based on specific criteria related to your head injury and overall health condition.

Quick self-check

Are you 18 years old or older?
Have you been admitted to an intensive care unit (ICU)?
Is your ICU admission due to a head injury?
Are you male or female? (Both are eligible)

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you are eligible and agree to take part, you would be randomly assigned to receive either the study medicine (propranolol) or a dummy pill (methylcellulose). You, your doctors, and the research team will not know which one you are taking. The study medicine will be given while you are in the intensive care unit.

Throughout your time in the hospital, the study team will closely monitor your health and recovery. The main thing they will be looking at is your survival rate in the hospital. They will also track your general recovery using standard medical assessments. There will be follow-up assessments after you leave the hospital to see how you are doing over a longer period. The total duration of your participation would depend on your hospital stay and follow-up schedule.

Potential risks and benefits

Potential benefits of participating could include receiving a treatment that may improve recovery and survival after a head injury, especially if propranolol proves to be effective. As with any medicine, there are potential risks and side effects associated with propranolol, which your doctors will discuss with you. These can include things like low blood pressure or a slower heart rate. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Spain

Common questions

What is propranolol?

Propranolol is a medicine that's already used for various conditions like heart problems or anxiety. In this study, we're seeing if it can help people with head injuries.

What is a 'dummy pill'?

A 'dummy pill', or placebo, looks just like the real medicine but contains no active ingredients. It helps researchers fairly compare the active medicine's effects.

Why is it called 'triple-blind'?

Triple-blind means that you, your doctor, and the researchers won't know whether you're receiving the actual medicine or the dummy pill. This makes the study results more reliable.

Will my care change if I join the study?

Your medical care will remain the highest priority. Taking part means receiving either the study medicine or the dummy pill in addition to your standard care.

How long will I be in the study?

The main part of the study takes place while you are in the hospital. There will also be follow-up checks after you leave to see how you are recovering over time.