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EFFICACY OF PROPRANOLOL IN TRAUMATIC BRAIN INJURY PATIENTS ADMITTED TO THE ICU: A PROSPECTIVE, RANDOMIZED, TRIPLE-BLIND STUDY (ProP TBI in ICU)
EU CTIS ID: 2025-524194-17-00
What this study is testing
To compare in-hospital mortality in patients with TBI requiring ICU admission after receiving 14 days of treatment with propranolol versus placebo
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged 18 or under 80 years (both inclusive) who have suffered a moderate or severe TBI (GCS 3-13) and require ICU admission
- Informed consent must be signed by the patient or their legal representative if 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) 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
- Study start within the first 96 hours after the injury
You likely can't join if
- Age 17 years or younger or 81 years or older (both included)
- Preexisting asthma or bronchospasm
- Patients with spinal cord injuries
- Patients with bilateral mydriasis upon admission
- Patients with a poor prognosis and a life expectancy of less than 24 hours
- Pregnant women
See the full eligibility criteria
- Patients aged 18 or under 80 years (both inclusive) who have suffered a moderate or severe TBI (GCS 3-13) and require ICU admission
- Informed consent must be signed by the patient or their legal representative if 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) 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
- Study start within the first 96 hours after the injury
- Age 17 years or younger or 81 years or older (both included)
- Preexisting asthma or bronchospasm
- Patients with spinal cord injuries
- Patients with bilateral mydriasis upon admission
- Patients with a poor prognosis and a life expectancy of less than 24 hours
- Pregnant women
- Patients for whom follow-up at 1 month and 6 months cannot be guaranteed
- Patients unable to take oral medication due to swallowing problems and for whom nasogastric tube placement is not indicated
- Patients enrolled in another clinical trial
- 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
- Lactic acid greater than 2 mmol/L at the time of randomization
- Patients with a history of TBI for more than 96 hours
- Polytrauma patients with an extracranial Injury Severity Score greater than 18 points or an extracranial AIS score ≥4 points in any region
- Patients with penetrating TBI
- 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%
- Patients on home treatment with digoxin, diltiazem, or verapamil
- Patients on beta-blocker treatment prior to admission
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.