Propranolol hydrochloride for Traumatic brain injury | Head injury

Inclusion criteria

• {"criterion_text":"- Patients aged 18 or under 80 years (both inclusive) who have suffered a moderate or severe TBI (GCS 3-13) and require ICU admission\n- Informed consent must be signed by the patient or their legal representative if the patient is unable to do so\n- Before starting the trial, the patient must be hemodynamically stable, defined as having a systolic blood pressure (SBP) greater than 110 mmHg, cerebral perfusion pressure (CPP) greater than 60 mmHg (in patients with ICP monitoring), and a heart rate (HR) greater than 60 beats per minute. Patients with these hemodynamic parameters may be included with a dose lower than 0.10 mcg/kg/min of norepinephrine base\n- Study start within the first 96 hours after the injury"}

Exclusion criteria

• {"criterion_text":"- Age 17 years or younger or 81 years or older (both included)\n- Hemodynamically unstable patients, defined as systolic blood pressure less than 109 mmHg, cerebral perfusion pressure less than 59 mmHg (in patients with ICP monitoring), and heart rate less than 59 beats per minute, who require norepinephrine base at doses greater than 0.11 mcg/kg/min\n- Lactic acid greater than 2 mmol/L at the time of randomization\n- Patients with a history of TBI for more than 96 hours\n- Polytrauma patients with an extracranial Injury Severity Score greater than 18 points or an extracranial AIS score ≥4 points in any region\n- Patients with penetrating TBI\n- Preexisting 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 less than 40%\n- Patients on home treatment with digoxin, diltiazem, or verapamil\n- Patients on beta-blocker treatment prior to admission\n- Preexisting asthma or bronchospasm\n- Patients with spinal cord injuries\n- Patients with bilateral mydriasis upon admission\n- Patients with a poor prognosis and a life expectancy of less than 24 hours\n- Pregnant women\n- Patients for whom follow-up at 1 month and 6 months cannot be guaranteed\n- Patients unable to take oral medication due to swallowing problems and for whom nasogastric tube placement is not indicated\n- Patients enrolled in another clinical trial"}

Primary endpoints

• {"endpoint_text":"- Hospital mortality","definition_or_measurement_approach":"In-hospital death (hospital mortality) as recorded during the index admission."}

Secondary endpoints

• {"endpoint_text":"- Glasgow outcome scale extended","definition_or_measurement_approach":"Glasgow Outcome Scale Extended (GOS-E). Secondary objectives specify comparison of percentage with a good outcome (GOS-E ≥5) at one month and at 6 months after the trauma."}

Spain

Earliest CTIS Part Ii Submission Date

18-11-2025

Latest Decision Or Authorization Date

05-02-2026

Processing Time Days

79

Number Of Sites

6

Number Of Participants

600

Primary sponsor

Full Name

University Hospital Son Espases

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain