A Phase 3 interventional study of Propranolol + Placebo in Traumatic Brain Injury (TBI) Patients, sponsored by Fundació d'investigació Sanitària de les Illes Balears. Recruiting at 6 sites in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Fundació d'investigació Sanitària de les Illes Balears · Phase 3, Interventional, and Treatment
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 of ICU discharge, as well as better long-term functional outcomes. However, the lack of high-quality scientific evidence clearly limits the ability to make a generalized recommendation regarding the use of beta-blockers in these patients. Therefore, further clinical trials are needed to analyze the effect of beta-blockers on mortality and short- and long-term functional outcomes in patients with TBI admitted to an Intensive Care Unit (ICU).
The Prop-TBI in ICU trial is a prospective, randomized, multicenter, triple-blind clinical trial with two parallel treatment groups, designed to evaluate the efficacy of propranolol versus placebo in patients with traumatic brain injury (TBI) requiring ICU admission.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 536 is above the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Fundació d'investigació Sanitària de les Illes Balears is the lead sponsor of 20 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with TBI admitted to these hospitals who meet the inclusion/exclusion criteria will be randomized to receive propranolol or placebo, administered orally or via nasogastric tube, for 14 days.
Drug: Propranolol + Placebo
Patients with TBI admitted to these hospitals who meet the inclusion/exclusion criteria will be randomized to receive propranolol or placebo, administered orally or via nasogastric tube, for 14 days. The propranolol dosages used are those typically employed in the ICU: treatment begins with an initial dose of 10 mg every 6 hours (40 mg/day), which may be increased to a maximum of 40 mg every 4 hours (maximum 240 mg/day) based on blood pressure and heart rate parameters.
Drug: Propranolol + Placebo
Patients with TBI admitted to these hospitals who meet the inclusion/exclusion criteria will be randomized to receive propranolol or placebo, administered orally or via nasogastric tube, for 14 days. The propranolol dosages used are those typically employed in the ICU: treatment begins with an initial dose of 10 mg every 6 hours (40 mg/day), which may be increased to a maximum of 40 mg every 4 hours (maximum 240 mg/day) based on blood pressure and heart rate parameters.
In-hospital mortality
To compare in-hospital mortality in patients with traumatic brain injury (TBI) requiring ICU admission after receiving 14 days of treatment with propranolol versus placebo.
Time frame: Through study completion
Extended Glasgow Outcome Scale score
To compare the percentage of patients with traumatic brain injury (TBI) showing a good outcome (GOSE score ≥5) after receiving 14 days of treatment with propranolol versus placebo, at 1 month and 6 months post-injury. Glasgow Outcome Scale-Extended (GOSE) is a standardized 8-point clinical tool used to assess a patient's level of functional recovery and independence after a traumatic brain injury (TBI). From 1 (dead) to 8 (upper good recovery).
Time frame: 1-month GOSE; 6-month GOSE
Adverse events
-Compare the occurrence of adverse effects between the two groups during the 14-day treatment period.
Time frame: 14-day treatment period
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All IPD collected throughout the trial under request to the PI
Supporting information: Study protocol, Statistical analysis plan
Time frame: December 1st of 2028
Access criteria: All study data will be available under request to the PI
Started Jun 2026 (actual). Primary completion is estimated for Jun 2028, 24 months after the start.
Of 30 phase 3 interventional studies under Brain Injuries, Traumatic, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 69. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Fundació d'investigació Sanitària de les Illes Balears