RED DIAMOND

Date Opened: October 2014
Type:
Prospective observational Cohort Study
Size: Single centre
Current status:
Open
Recruitment to date: 8
Lead researchers: Prof Tony Belli, Mr. David Davies

 

Overview

When people suffer a brain injury, currently the only way in which the brain tissue is currently examined in terms of pressure and oxygen delivery is by the insertion of probes into the skull and brain tissue itself. Not only is this obviously invasive but it confines detailed brain tissue monitoring to the intensive care unit.

Near Infra Red Light has fascinating properties in that it can pass through biological tissue and be used to identify hemoglobin, and how much oxygen is attached to the hemoglobin within tissues. This technology at the moment is used frequently to monitor the levels of oxygen in the blood via a finger probe giving an indication of lung function.

Although the technology is currently available to monitor brain oxygen levels using Infra Red Light (or Near Infra Red Light) it has up until now not been considered sufficiently accurate to be used in traumatic brain injury. The SRMRC research team is developing a refined and improved method of non-invasively monitoring the brain using these techniques.

In the RED DIAMOND study (Near Infra RED Cerebral Spectroscopy in the DIrection And early MONitoring of therapy in patients with traumatic brain injury) we aim to compare this method to other commonly used monitoring methods to develop a system that is sufficiently accurate that it can be used in brain trauma, in some cases replacing invasive probes. It is intended that this system can be used in many different areas of care outside of the intensive care unit, providing a real benefit to individuals who suffer brain injury in the future.

Who is eligible?

Inclusion criteria

  • Male and female patients aged over 16 years
  • Mild, Moderate and Severe TBI
    • Diagnosed by clinical history, initial GCS and presenting CT scan
  • Meet clinical criteria required for hospital admission (all patients included should meet the clinical criteria to require a CT scan as per NICE and local trust guidelines).

Exclusion Criteria

  • Significant facial laceration or bony injury
  • Significant scalp haematoma
  • Clinically active skin pathology over the face or scalp which could be irritated by the application of the NIRS device.
  • Previous craniotomy or cranioplasty (prior to admission)
  • Childhood hydrocephalis
  • Conjenital cranio facial disorders leading to abnormal skull anatomy (sagital synoestosis, Cruzons etc)
  • Bilateral fixed and dilated pupils at presentation
  • Devastating injury unlikely to survive 24 hours
  • History of significant previous neurological pathology (e.g. stroke, Alzheimer’s disease)

The trial:

Patients admitted to the QEHB with a traumatic brain injury and who fit all eligibility criteria are recruited to the study, where they will undergo standard indicated multi modal monitoring ( ) alongside Near Infra Red concurrent monitoring. Patients will be assessed at fixed time points using established and validated outcome measures, as listed below:

  • Patient medical history and background Data.
  • Blood Samples (taken as soon as possible after injury and then at intervals to 6 months) to investigate markers of brain injury and genes which may either protect against injury or predispose to it.
  • Cerebrospinal fluid collection if also required for diagnostic purposes.
  • Microdialysis of pressure monitoring fluid, if monitoring also required as part of patient’s treatment.
  • Health and wellbeing data obtained via questionnaires

Measuring success:

The aim of the study is to demonstrate an acceptable correlation between this refined NIRS monitoring systems and established clinical, biochemical and invasive measures used to quantify severity of injury and direct therapy in traumatic brain injury. Furthermore, the study would be deemed successful if NIRS monitoring is useful in the prediction of outcome in these individuals.

From this it is hoped that NIRS imaging could be implemented as a versatile non-invasive form of cerebral tissue monitoring, with potential to be used in situations were currently brain tissue imaging and monitoring are not normally carried out, which would include the pre-hospital or Emergency Department resuscitation environment.

Lead researchers

  • RED DIAMOND

    Professor Tony Belli

    Director of the NIHR SRMRC / Tony Belli's team

    Mr Belli is the principal or chief investigator of several acute brain injury studies, including an international drug trial for the treatment of traumatic brain injury which has opened at UHB.

    Professor Tony Belli
  • RED DIAMOND

    David Davies

    / Tony Belli's team

    David Davies