Beta Blocker Use In Traumatic Brain Injury Based On The High-Sensitive Troponin T Status

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Beta blockers (BB) play an important role in protection of end organs that are susceptible for secondary injury by the Traumatic brain injury (TBI)-induced catecholamine surge. However, use of BBs in trauma patients is not yet the standard of care which necessitates clear scientific evidence and justification to be used especially in TBI patients. The BBTBBT study aims to determine whether early administration of propranolol based on the HSTnT status will improve the outcome of mild-to-severe TBI patients. Our primary hypothesis is that BBs are effective in reducing 10 and 30-day mortality in TBI patients.BBs are effective in reducing 10 and 30-day mortality in TBI patients.

Methods/Design: The BBTBBT study is a prospective, randomized, double-blinded, placebo-controlled trial, three-arm trial of BB use in mild-to-severe TBI patients based on the HsTnT status.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamad Medical Corporation
• Treatments: Propranolol

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.