The protocol based clinical care embodied in the Cambridge Neurosciences/Trauma Critical Care Unit, and our interactions with health technology through the HTC have provided critical frameworks for identifying gaps in technology (see earlier) and refining and validating new technologies for both diagnostic and therapeutic use. These interactions are proceeding at several different stages in several areas. We describe below two exemplars of projects that are at different stages in this collaboration pathway within our theme:
Exemplar 1: Development of a sensor for near-patient monitoring of haemostasis
Conventional coagulation testing is largely unhelpful in stratifying bleeding risk or guiding correction of haemostatic defects – both of which are critical issues in acute brain injury, particularly in an increasingly elderly population (50% of TBI patients in ICU are over 50 years) who have multiple comorbidities and are on antiplatelet and anticoagulant therapy. Viscoelastic testing (with TEGR and ROTEMR) is helpful, but expensive and not widely available. Ercole (in collaboration with Dr Seshia, Dept of Engineering) is developing semiconductor based sensors with integrated microfluidics for near-patient haemostasis testing. They have shown confirmed that such based biosensors, constructed from thin silicon films patterned and etched using standard semiconductor foundry processing and co-integrated together with microfluidic sample handling can be useful as a near-patient device for haemostasis measurement. The project has received seed funding from Cambridge University Hospital Trust to help prepare for a substantive grant.
Exemplar 2: NeuronGuard – Development of a device for temperature management in brain injury
This project has involved interaction with a commercial firm, which interacted with the HTC following one of our scoping exercises. Following initial design refinement with help of HTC members, a device for the selective management of brain temperature after brain injury is under development. The device has potential for application in the pre-hospital phase of an injury as well as emergency and acute care. There is also potential intra operatively to provide neural protection. The subtheme will work closely with NeuronGuard to develop a trial protocol to undertake the initial clinical investigation to support CE marking of the device and produce the necessary reports and documentation to submit to the MHRA. Subsequent to obtaining a CE mark larger clinical trials will be required to provide the evidence base to support clinical implementation.