Traumatic Brain Injury (TBI) PatientsPhase 3ProP-TBI ICUNCT07899164
Efficacy of Propranolol in Traumatic Brain Injury Patients Admitted to the ICU: A Prospective, Randomized, Triple-Blind Study
A Phase 3 study of Traumatic Brain Injury (TBI) Patients, run by Fundació d'investigació Sanitària de les Illes Balears at 6 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Traumatic Brain Injury (TBI) Patients
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 536 participants
- Where
- 6 sitesSpain
- Study dates
- 1 Jun 2026to 1 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Spain6 sites, 6 recruiting
- Not yet recruiting
Hospital Germans Trias i Pujol
Badalona
Mireia Anglada Olivan, MD, +34934651200, manglada.germanstrias@gencat.cat
- Recruiting
Hospital Universitario de Burgos
Burgos
Arturo Zabalegui Pérez, MD, +34947281800, arturozabalegui@gmail.com
- Recruiting
Hospital Universitario Arnau de Vilanova
Lleida
Gabriel Jimenez, MD, +34973248100, gabrijj1189@gmail.com
- Recruiting
Hospital 12 de Octubre
Madrid
Jesus Barea Mendoza, MD, +34913908000, elbarea@gmail.com
- Recruiting
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120
Jon Pérez Bárcena, MD, +34620454370, juan.perez@ssib.es
- Recruiting
Hospital Universitario de Toledo
Toledo
Guillermo Morales Varas, MD, +34925269200, guillermo.moralesvaras@gmail.com
About this study
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).
Read the detailed description
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.
- Conditions
- Traumatic Brain Injury (TBI) Patients
- Being tested
- Propranolol + Placebo
- Keywords
- traumatic brain injury, propranolol, clinical trial
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol + PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Drug: Propranolol + Placebo |
| Propranolol | Experimental | 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. Receives: Drug: Propranolol + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion
Secondary outcomes (2)
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).
Measured: 1-month GOSE; 6-month GOSE
Adverse events
-Compare the occurrence of adverse effects between the two groups during the 14-day treatment period.
Measured: 14-day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI) PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 536 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació d'investigació Sanitària de les Illes Balears
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899164
- Sponsor's protocol ID
- Prop-TCE 04-2025
- Other IDs
- 2025-524194-17-00, 2025
- Acronym
- ProP-TBI ICU
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial under request to the PI
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Propranolol in Traumatic Brain Injury Patients Admitted to the ICU: A Prospective, Randomized, Triple-Blind Study
- ClinicalTrials.gov ID
- NCT07899164
- Acronym / sponsor ID
- ProP-TBI ICU / Prop-TCE 04-2025
- Conditions
- Traumatic Brain Injury (TBI) Patients
- Keywords
- traumatic brain injury, propranolol, clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 536 participants (estimated)
- Lead sponsor
- Fundació d'investigació Sanitària de les Illes BalearsOther government
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Propranolol + PlaceboPatients 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. |
| Propranolol | Experimental | Drug: Propranolol + PlaceboPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propranolol + PlaceboPatients 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 | Placebo, Propranolol |
Primary outcome
In-hospital mortality
Time frame: Through study completion
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.
2 secondary outcomes
Extended Glasgow Outcome Scale score
Time frame: 1-month GOSE; 6-month GOSE
Adverse events
Time frame: 14-day treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial under request to the PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Traumatic Brain Injury (TBI) Patients, run by Fundació d'investigació Sanitària de les Illes Balears at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jon Pérez Bárcena, MD (+34620454370, juan.perez@ssib.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: Through study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.