💬In plain words
What the trial is, and whether it could suit you
Beta-blockers have shown promise as a treatment to improve patient prognosis following traumatic brain injury (TBI), although the exact mechanism by which they might confer this benefit remains unknown.
At the clinical level, several retrospective cohort studies, prospective cohort studies, small prospective clinical trials, and various reviews and meta-analyses suggest that beta-blockers may be associated with an improved prognosis in patients with TBI. Furthermore, the optimal timing, dosage, and duration of beta-blocker treatment remain uncertain. This means there is still uncertainty regarding the overall efficacy of beta-blockade in patients with TBI, as well as the specifics of patient selection, drugs, dosages, routes of administration, and physiological targets.
In summary, the use of beta-blockers in patients with TBI appears to be associated with reduced mortality at the time
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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