Early EVD for ICP treatment in TBI, V1.3
Research type
Research Study
Full title
Early placement of external ventricular drains versus standard care (late or no placement of external ventricular drain) in the treatment of severe traumatic brain injury – a prospective, randomised, pilot trial
IRAS ID
264870
Contact name
Selma Tülü
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and The University of Cambridge
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
After a severe brain injury, the brain can suffer seubsequent swelling and the pressure inside the skull might increase, which can cause further damage to the brain. That is why it is necessary to place probes inside the brain of these patients which allow the clinicians to monitor the brain pressure. There are several methods to address elevated brain pressure, one is the placement of an "external ventricular drain" (EVD) inside the cavities of the brain. This allows drainage of cerebrospinal fluid which evidently helps to relief brain pressure.
Although we know that EVDs help lower brain pressure, there is currently no evidence that shows us when it is the best time to implant the drain.
The main purpose of our trial is to investigate two different timing strategies of EVD placement and compare them to each other. We aim to find out, whether an early drain placement spares these patients further advanced measures and surgical procedures to control the brain pressure using a scale called "therapeutic intesity level"(=TIL). The TIL assigns points to all measures that are taken to lower brain pressure and provides a sum score of treatment intensity.
By comparing the TIL score of patients undergoing an early EVD placement with patients of the control group (late or no EVD placement), we aim to objectify possible differences between the two timing strategies.
The trial will take place as a two-centre pilot trial at the Addenbrooke's Hospital in Cambridge, UK and the Innsbruck Medical University, Austria. Adult patients with a severe traumatic brain injury and the necessity of brain monitoring will be considered for study inclusion. Participants will be randomly assigned to one of the two study arms and TIL will be assessed daily. Functional outcome will be scored six months after the initial trauma using the extended Glasgow Outcome Scale.
REC name
London - Harrow Research Ethics Committee
REC reference
20/LO/0092
Date of REC Opinion
17 Sep 2020
REC opinion
Further Information Favourable Opinion