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Clinical Trials/2025-524194-17-00
2025-524194-17-00RecruitingPhase 3

EFFICACY OF PROPRANOLOL IN TRAUMATIC BRAIN INJURY PATIENTS ADMITTED TO THE ICU: A PROSPECTIVE, RANDOMIZED, TRIPLE-BLIND STUDY (ProP TBI in ICU)

University Hospital Son Espases6 sites in 1 country600 target enrollmentStarted: February 5, 2026Last updated:
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Trial Snapshot

Phase
Phase 3
Status
Recruiting
Sponsor
Enrollment
600
Locations
6
Primary Endpoint
Hospital mortality
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Allocation
Randomized
Primary Purpose
Efficacy Of Propranolol In Traumatic Brain Injury Patients Admitted To The Icu
Masking
Double (Subject, Analyst, Investigator, Monitor, Carer)

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
Yes

Inclusion 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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Hospital mortality

Hospital mortality

Secondary Outcomes

  • Glasgow outcome scale extended

Investigators

Sponsor
University Hospital Son Espases
Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Principal investigator

Scientific

University Hospital Son Espases

Study Sites (6)

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