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A Study Testing Propranolol for Patients with Traumatic Brain Injury Who Need Intensive Care Unit Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves patients who have suffered a head injury and require care in an intensive care unit. The injury being studied is specifically moderate or severe traumatic brain injury, which is a serious condition that occurs when an external force causes damage to the brain. The study will compare two treatments: propranolol hydrochloride, which is a medication that belongs to a group of medicines called beta-blockers that affect the heart and blood circulation, and placebo. Some patients will also receive methylcellulose as part of the study. Both treatments will be given by mouth in tablet or capsule form for a period of 14 days.

The purpose of the study is to compare survival rates in the hospital between patients who receive propranolol and those who receive placebo. The study will look at whether propranolol can help reduce the number of deaths that occur in the hospital among patients with traumatic brain injury who are admitted to the intensive care unit. The study will also examine the overall recovery and functional outcome of patients using a measurement scale that assesses how well patients are able to function after their injury.

Patients can be enrolled in the study within the first 96 hours after their injury occurs. Before treatment begins, patients must be in stable condition with adequate blood pressure, heart rate, and blood flow to the brain. The treatment will continue for 14 days with a maximum daily dose of 240 milligrams. Patients or their legal representatives must provide consent to participate in the study. The study is designed so that neither the patients, their doctors, nor the researchers know which treatment is being given during the study period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessment

    Your participation in the study will begin within the first 96 hours after your head injury.

    Before starting the treatment, your medical team will confirm that your condition is stable. This means your systolic blood pressure (the higher number in a blood pressure reading) must be greater than 110 mmHg, your heart rate must be greater than 60 beats per minute, and if a device is monitoring the pressure inside your skull, your cerebral perfusion pressure (blood flow to the brain) must be greater than 60 mmHg.

    Either you or your legal representative will need to sign an informed consent form before the study begins.

  2. Step 2

    Treatment period

    You will receive either propranolol or a placebo (an inactive substance with no medication). The assignment will be random, and neither you, your doctors, nor the research team will know which treatment you are receiving.

    The medication will be given by mouth in tablet form.

    The treatment will continue for 14 days.

    The specific dosage and frequency of administration will be determined by the study protocol based on your individual condition.

  3. Step 3

    Monitoring during hospital stay

    Throughout your hospital stay, your medical team will monitor your condition and recovery.

    Your vital signs, brain function, and overall health status will be assessed regularly while you remain in the intensive care unit and during your hospital admission.

  4. Step 4

    Assessment of outcomes

    The primary measure being evaluated is survival during your hospital stay.

    Your functional outcome will also be assessed using the Glasgow Outcome Scale Extended, which is a standardized tool that measures recovery and quality of life after a head injury.

Who can join the trial?

7 criteria

  • You must be 18 years old or older, but younger than 80 years old
  • You must have experienced a moderate or severe traumatic brain injury, which means a serious injury to the head that affects how the brain works, measured by a scale called GCS (Glasgow Coma Scale, a scoring system that checks your level of consciousness) with a score between 3 and 13
  • You must need to be admitted to the ICU (Intensive Care Unit, a special hospital unit for patients who need close monitoring and intensive treatment)
  • You or your legal representative must sign an informed consent form, which is a document that explains the study and confirms you agree to participate
  • Before joining the study, you must be hemodynamically stable, which means your blood circulation and heart function are stable enough, with the following measurements: your systolic blood pressure (the top number in a blood pressure reading, showing the pressure when your heart beats) must be higher than 110 mmHg, your heart rate (number of heartbeats per minute) must be higher than 60 beats per minute, and if you have a device monitoring pressure inside your skull, your cerebral perfusion pressure (the pressure needed to keep blood flowing to your brain) must be higher than 60 mmHg
  • You may be included if you need a low dose of a medication called norepinephrine (a drug that helps maintain blood pressure) at less than 0.10 mcg/kg/min
  • You must be able to start the study within 96 hours (4 days) after your injury occurred

Who cannot join the trial?

1 criterion

  • No specific exclusion criteria have been provided for this clinical trial in the available information.
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Investigated drugs

Propranolol is a medication that belongs to a group of medicines called beta-blockers. It works by slowing down the heart rate and reducing the force of heart contractions. In this trial, propranolol is being tested to see if it can help reduce death rates in patients with traumatic brain injury who need intensive care treatment.

What is already known about the treatment

Propranolol – Propranolol is a medication that belongs to a group of drugs called beta-blockers, which work by blocking certain natural substances in the body, such as adrenaline, from affecting the heart and blood vessels. It is commonly used to treat high blood pressure, irregular heartbeats, anxiety, and to prevent migraines, and it is typically taken by mouth in tablet form or given through a vein in hospital settings. In this clinical trial, researchers are studying whether propranolol can help reduce death rates in patients with traumatic brain injury who need intensive care unit treatment. The medication works at the molecular level by blocking beta-adrenergic receptors, which helps slow down the heart rate, reduce the force of heart contractions, and decrease the body's stress response that might worsen brain injury.

Investigated diseases

Traumatic Brain Injury – Traumatic brain injury is a condition that occurs when an external force causes damage to the brain, typically from a blow, bump, or jolt to the head. The injury can result from various incidents such as falls, vehicle accidents, sports injuries, or physical assaults. Following the initial impact, the brain may experience swelling, bleeding, or bruising, which can lead to increased pressure inside the skull. Symptoms can range from mild confusion and headaches to severe problems with consciousness, memory, and physical coordination. The condition may cause temporary or prolonged changes in how the brain functions, affecting a person's ability to think, move, and interact with others. Recovery progress varies significantly depending on the severity of the initial injury and which areas of the brain were affected.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524194-17-00Protocol codeProp-TCE 04-2025Estimated enrolment600 patientsSponsorUniversity Hospital Son Espases

sourced from the EU Clinical Trials Register and site verification

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