Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-24 @ 12:20 PM
NCT ID:
NCT06262061
Eligibility Criteria:
Inclusion Criteria
1. Adult patients (\>18/= 18 years of age) who have sustained a TBI
2. Initial GCS during the first 6 hours of assessment of 5- 12 (inclusive)
Exclusion Criteria
1. Home beta- blocker therapy
2. New indication for beta- blocker therapy during hospital stay
3. Contraindication to beta- blocker therapy
1. Allergy
2. Severe asthma/ COPD
3. Sinus bradycardia and greater than first degree block
4. Patients in cardiogenic shock
5. Right ventricular failure secondary to pulmonary hypertension
6. Congestive heart failure unless the failure is secondary to a tachyarrhythmia treatable with propranolol
4. Patients requiring any vasoactive medications to maintain their blood pressure at the time of enrollment
5. Patients requiring or are on any of the following medications:
1. Digitalis
2. Anesthetic agents that maintain cardiac contractility by virtue of their effect on catecholamine release (e.g., ether)
3. Epinephrine, noradrenaline, adrenaline, and isoproterenol
4. Antiarrhythmic cardiac depressant drugs such as procainamide or quinidine
5. Thiazide-like diuretics and/or peripheral vasodilators
6. Catecholamine depletion drugs such as reserpine or guanethidine
6. Patients not expected to survive 48 hours
7. \>24 hours from trauma at the time of enrollment
a. Patients on vasoactive medications at initial trial screening may enter the trial if their vasopressor requirements cease within 24 hours of their trauma
8. Inability to secure enteral access for medication administration
9. Doses of BB will be held under the following circumstances
a. HR \<45 or MAP \<55 for 5 minutes prior to administration time
10. Patients that are pregnant and/or breastfeeding participants
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06262061
Study Brief:
Protocol Section:
NCT06262061