Efficacy of Propranolol in Traumatic Brain Injury Patients Admitted to the ICU: a Prospective, Randomized, Triple-Blind Study (ProP Tbi in ICU)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Hospital Son Espases

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Decision date (initial)

2026-02-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To compare in-hospital mortality in patients with TBI requiring ICU admission after receiving 14 days of treatment with propranolol versus placebo

Secondary objectives 2

1. To compare the percentage of patients with TBI who show a good outcome (Glasgow Outcome Scale Extended ≥5 points) after receiving 14 days of treatment with propranolol compared to placebo at one month and 6 months after the trauma
2. To compare the presence of adverse effects between the two groups during the 14 days of treatment

Conditions and MedDRA coding

Head injury

Study design 1 period

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients aged 18 or under 80 years (both inclusive) who have suffered a moderate or severe TBI (GCS 3-13) and require ICU admission
2. Informed consent must be signed by the patient or their legal representative if the patient is unable to do so
3. 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
4. Study start within the first 96 hours after the injury

Exclusion criteria 17

1. Age 17 years or younger or 81 years or older (both included)
2. 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
3. Lactic acid greater than 2 mmol/L at the time of randomization
4. Patients with a history of TBI for more than 96 hours
5. Polytrauma patients with an extracranial Injury Severity Score greater than 18 points or an extracranial AIS score ≥4 points in any region
6. Patients with penetrating TBI
7. 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%
8. Patients on home treatment with digoxin, diltiazem, or verapamil
9. Patients on beta-blocker treatment prior to admission
10. Preexisting asthma or bronchospasm
11. Patients with spinal cord injuries
12. Patients with bilateral mydriasis upon admission
13. Patients with a poor prognosis and a life expectancy of less than 24 hours
14. Pregnant women
15. Patients for whom follow-up at 1 month and 6 months cannot be guaranteed
16. Patients unable to take oral medication due to swallowing problems and for whom nasogastric tube placement is not indicated
17. Patients enrolled in another clinical trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Hospital mortality

Secondary endpoints 1

1. Glasgow outcome scale extended

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Hospital Son Espases

Sponsor organisation

University Hospital Son Espases

Address

Carretera Valldemossa 79

City

Palma

Postcode

07120

Country

Spain

Scientific contact point

Organisation

University Hospital Son Espases

Contact name

Principal investigator

Public contact point

Organisation

University Hospital Son Espases

Contact name

Principal investigator

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications