Early beta-blockade in severe traumatic brain injury (EBB-TBI)
Research type
Research Study
Full title
Early intravenous beta-blockade with esmolol in adults with isolated severe traumatic brain injury: a phase 2a intervention design study
IRAS ID
272010
Contact name
Matt Thomas
Contact email
Sponsor organisation
North Bristol NHS Trust
Eudract number
2019-003512-32
Duration of Study in the UK
1 years, 6 months, 3 days
Research summary
Damage to the brain following an accident has two forms. Primary injury happens at the moment of impact and cannot be altered. Secondary injury happens after the event. It can be improved by medical treatment. Less secondary injury means patients are likely to do better.
One cause of secondary injury is adrenaline. Adrenaline is a hormone released in massive amounts at the time of the accident and days after. Adrenaline supports blood pressure, helping deliver oxygen to the brain.
High levels can damage the lining of blood vessels making them leaky. This produces swelling and inflammation reducing oxygen supply to damaged areas of brain. This leads to a vicious cycle of more swelling and inflammation. The result is secondary brain injury.
Blocking adrenaline with beta-blockers may break the cycle. Clinical databases suggest that patients on beta-blockers do better after traumatic brain injury. Beta-blockers have side effects that may be harmful in this context. Before trials it is essential to know that the drug and doses to be tested are safe.
We aim to design a course of beta-blocker treatment for adults early after serious head injury using a drug called esmolol. Esmolol is quick to act and wear off. It is already used to control heart rate and blood pressure in patients in intensive care.
In one previous study patients with septic shock received esmolol. Like patients after severe brain injury, the patients were on life support and getting drugs to support blood pressure. Esmolol actually increased blood pressure and patients on esmolol were more likely to survive.
Our research is based on similar esmolol doses to this study. After each group of 3 patients we will consider changing doses. At the end of the study we will have established a safe protocol for esmolol early after brain injury.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
20/SC/0219
Date of REC Opinion
23 Jul 2020
REC opinion
Further Information Favourable Opinion