Using beta blockers to improve outcomes in traumatic brain injury patients based on troponin levels
Beta Blocker Use In Traumatic Brain Injury Based On The High-Sensitive Troponin T Status: A Randomized Controlled Trial (BBTBBT)
PHASE4 · Hamad Medical Corporation · NCT04508244
This study is testing if giving beta blockers early can help improve survival rates for patients with traumatic brain injuries who have high troponin levels.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 771 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hamad Medical Corporation (industry) |
| Locations | 1 site (Doha) |
| Trial ID | NCT04508244 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of early administration of propranolol, a beta blocker, in patients with mild-to-severe traumatic brain injury (TBI) based on their high-sensitive troponin T (HsTnT) status. It is a prospective, randomized, double-blinded, placebo-controlled trial designed to assess whether beta blockers can reduce 10 and 30-day mortality rates in TBI patients. The study aims to provide clear scientific evidence for the use of beta blockers in this patient population, which is not yet standard practice. By focusing on troponin levels, the trial seeks to identify patients who may benefit most from this treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with mild-to-severe blunt traumatic brain injuries requiring hospital admission.
Not a fit: Patients with penetrating trauma, non-survivable injuries, or those with certain pre-existing conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates for patients with traumatic brain injury.
How similar studies have performed: While some studies have explored the relationship between troponin levels and TBI outcomes, the specific use of beta blockers based on HsTnT status in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All adults (≥18 -65 years) * both genders * mild-to-severe blunt TBI (head AIS 1-5 and/ GCS 4-15) patients requiring hospital admission Exclusion Criteria: * Patients \<18 and\> 65 yrs old * penetrating trauma * non-survivable injuries (head AIS=6 \& GCS=3) * uncontrolled bleeding on arrival to ED * pregnant women * prisoners * patients with heart rate (HR) ≤70, systolic blood pressure (SBP) ≤100 mmHg (or MAP \<70 mmHg) not responding to initial management or required to be maintained on vasopressors on arrival . * Patients who will undergo hypothermia therapy, * any penetrating injury to head, thorax or abdomen, * history of bronchial asthma * patients posted for emergency surgery during the first 6 hrs.
Where this trial is running
Doha
- Hamad General Hospital — Doha, Qatar (RECRUITING)
Study contacts
- Principal investigator: Ayman El-Menyar, MD — Hamad Medical Corporation
- Study coordinator: Ayman El-Menyar, MD
- Email: aelmenyar@hamad.qa
- Phone: 44396130
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Trauma, Brain Injuries, Stress Reaction, Beta Blockers, Troponin, propranolol, troponin, biomarkers