March 7, 2024

UOW researchers to conduct clinical trial of patch to reduce bleeding complications

Trial will run out of Liverpool and Royal Brisbane and Women's Hospital

Associate Professor Evan Alexandrou and Professor Steve Frost, based at University of Wollongong’s (UOW) Liverpool Campus, have secured an Investigator Initiated Grant with American medical device company Biolife LLC to conduct a clinical trial that will test the effectiveness of a patch to reduce bleeding complications from vascular access devices.

Patients who are critically ill or who have cancer can be prone to mild bleeding after a vascular access device - a long thin catheter - is inserted into the upper arm, neck, chest or groin. This can lead to the sterile dressing that covers the device to fail, placing the patient at risk of complications such as catheter failure or a blood stream infection.

The clinical trial will test a device known as StatSeal, a patch or powder containing potassium ferrate that reacts with blood to dehydrate it, causing the blood solids to cluster together and form a seal around the blood exit site.

The StatSeal device has been developed by a US company (Biolife LLC) and has primarily been used in the United States and Europe for removal of devices after interventional procedures such as angiograms. This is the first randomised controlled trial testing the effectiveness of StatSeal to reduce the burden of vascular access device dressing failure from catheter exit site bleeding.  

The trial is set to commence at Liverpool Hospital (SWSLHD) and the Royal Brisbane and Women’s Hospital in May this year.

Professor Caleb Ferguson, Director Health Innovations in UOW’s Faculty of Science, Medicine & Health, congratulated Associate Professor Alexandrou and Professor Frost on receiving the industry grant.

“This clinical trial builds on the School of Nursing’s research strengths in acute, critical care and patient safety,” Professor Ferguson said.

“It is great to see Evan and Steve working closely with industry and other clinical partners to address real-world problems affecting clinical care and patient outcomes. Vascular access devices are widely used throughout acute care and can present a significant risk to patient safety and adverse events.

“Associate Professor Alexandrou and Professor Frost are embedded clinical researchers at Liverpool Hospital in South Western Sydney Local Health District and it is wonderful to see investigator-initiatedresearch being supported through industry, which will likely improve the uptake and translation of findings into clinical care.”