Loading search results

Outcome Measures

Primary Outcomes (1)

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.
Through study completion

Secondary Outcomes (2)

Extended Glasgow Outcome Scale score
1-month GOSE; 6-month GOSE
Adverse events
14-day treatment period

Study Arms (2)

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.

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.

Drug: Propranolol + Placebo

Interventions

Propranolol + PlaceboDrug

PlaceboPropranolol

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino Alcohols

Study Design

Study Type

interventional

Phase

phase 3

Allocation

RANDOMIZED

Masking

QUADRUPLE

Who Masked

PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR

Masking Details

A randomization list will be prepared for each hospital. The randomization code will be known only to the Pharmacy Department of Son Espases Hospital. The Son Espases Pharmacy Service will be responsible for preparing and packaging the propranolol/placebo capsules-sufficient for a 14-day treatment course-for all the hospitals. The containers of propranolol/placebo will be shipped from the Son Espases Pharmacy Service to the pharmacy departments of the hospitals participating in the clinical trial. Each hospital will have a limited, numbered supply of treatments, which will be used in sequential order. The preparation and packaging of capsules will be carried out in accordance with the standard operating procedures of the pharmaceutical technology laboratory and its quality controls, as previously authorized by the Spanish Medicines Agency in the study's technical dossier.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: 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.

Sponsor Type

OTHER GOV

Responsible Party

SPONSOR

Efficacy of Propranolol in Traumatic Brain Injury Patients Admitted to the ICU: A Prospective, Randomized, Triple-Blind Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Placebo

Propranolol

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Placebo

Propranolol

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations