Propranolol for Severe Traumatic Brain Injury in the ICU

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this multicenter phase 3 trial, adults with moderate to severe traumatic brain injury who require ICU care are randomized to receive propranolol or placebo for a defined period. The study aims to determine if beta-blockade with propranolol can improve outcomes, such as survival and functional recovery, compared with no propranolol. Participants are 18 to 80 years old, hemodynamically stable at enrollment, and must be treated within 96 hours of injury. The trial uses a triple-blind design to minimize bias and compares two parallel treatment arms at multiple centers. Primary and secondary endpoints likely include mortality and functional status, with safety monitoring for cardiovascular effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged 18 to 80 years (inclusive) who have sustained a moderate or severe traumatic brain injury (GCS 3-13) and require ICU admission.
* Signing of the informed consent by the patient or their legal representative, in the event that the patient is unable to do so.
* Before starting the trial, the patient must be hemodynamically stable, defined as having a systolic blood pressure (SBP) of 110 mmHg or higher, a cerebral perfusion pressure (CPP) of 60 mmHg or higher (for patients with ICP monitoring), and a heart rate (HR) of 60 beats per minute or higher. Patients meeting these hemodynamic parameters while receiving a noradrenaline dose lower than 0.10 µg/kg/min may be included.
* Initiation of the study within the first 96 hours following the trauma.

Exclusion Criteria:

* Age 17 years or younger, or 81 years or older (inclusive)
* Hemodynamically unstable patients, defined as having a systolic blood pressure of 109 mmHg or less, a cerebral perfusion pressure of 59 mmHg or less (in patients with ICP monitoring), and a heart rate of 59 beats per minute or less, and requiring a noradrenaline dose greater than 0.10 µg/kg/min.
* Lactic acid \>2 mmol/L at the time of randomization.
* Patients with a TBI of more than 96 hours' duration
* Polytrauma patients with an extracranial Injury Severity Score greater than 18 points or an extracranial AIS score of ≥4 in any region.
* Patients with penetrating traumatic brain injury.
* Pre-existing heart disease that contraindicates beta-blockers, such as first-, second-, or third-degree heart block without a permanent pacemaker; heart failure defined as an ejection fraction of less than 40%.
* Patients receiving home treatment with digoxin, diltiazem, or verapamil.
* Patients treated with beta-blockers prior to admission
* Pre-existing asthma or bronchospasm
* Patients with spinal cord injuries
* Patients with both dilated pupils upon admission
* Patients with a poor prognosis and a life expectancy inferior to 24 hours
* Pregnant or breastfeeding women (a pregnancy test is required before inclusion in the clinical trial)
* Patients with intolerance to any of the excipients contained in the propranolol or placebo capsules: lactose, calcium carboxymethylcellulose, gelatin (E441), magnesium stearate, hypromellose (E464), glycerol (E422), titanium dioxide (E171), carmine (E120), or sodium carboxymethylcellulose.
* Patients for whom follow-up at one month and six months cannot be guaranteed.
* Patients unable to take medication orally due to swallowing difficulties, and for whom the placement of a nasogastric tube is not indicated.
* Patients enrolled in another clinical trial

Where it's running

• Hospital Universitario Son Espases
  Palma de Mallorca, Balearic Islands, Spain Recruiting
• Hospital Universitario de Burgos
  Burgos, Spain Recruiting
• Hospital Universitario Arnau de Vilanova
  Lleida, Spain Recruiting
• Hospital 12 de Octubre
  Madrid, Spain Recruiting
• Hospital Universitario de Toledo
  Toledo, Spain Recruiting
• Hospital Germans Trias i Pujol
  Badalona, Spain Not yet recruiting

Study contacts

• Study coordinator: Jon Pérez Bárcena, MD
• Email: juan.perez@ssib.es
• Phone: +34620454370

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using a portable VR headset to measure pupil reactions for diagnosing and monitoring head injury

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.