HA380 Column in ICU patients on Extracorporeal support-a pilot study
Research type
Research Study
Full title
HA380 column Use in Critically ill patients receiving Extracorporeal support for acute Critical illness; a prospective, interventional, feasibility, randomised pilot study (HACEC)
IRAS ID
340801
Contact name
Hakeem Yusuff
Contact email
Sponsor organisation
University Hospitals of Leicester NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 31 days
Research summary
Patients who are critically ill either due to a severe infection, failure of vital organs to meet the body’s needs, trauma or following a major operation, may require significant temporary support of their organs. Devices commonly used for temporary organ support include: dialysis machines which remove the waste products and excess fluid from the blood, replacing the function of healthy kidneys and extracorporeal membrane oxygenation (ECMO) device, a type of artificial life support that can help a person whose lungs and/or heart are not functioning properly by temporarily doing the work of the lungs and/or the heart and gives them time to heal. The reaction of the body’s defence system to severe illness or injury is termed inflammation. Although the aim of the body’s inflammatory response is to trap bacteria and other offending agents or initiate healing of injured tissues, it can also significantly damage healthy cells, tissues, and organs. We would like to investigate the use of a device that can remove proteins (called ‘cytokines’), produced by blood cells called white blood cells. Cytokines are responsible for the inflammatory reaction and its deadly consequences on vital organs. The aim of this study is to provide valuable information that would enable us to establish whether a study to assess the use of this device to increase the chances of survival in critically ill patients is feasible. The device is a blood filter called HA380 and it would be connected to either the dialysis machine or the ECMO machine. We will assess the tolerability of using the HA 380 device. We will also assess the time spent on dialysis or ECMO machines, time spent on the breathing machine, time spent requiring drugs to support blood pressure, and time spent in the intensive care unit. Participants in this study will be randomly assigned to either receive treatment with the HA380 blood filter or standard treatment. We will recruit 40 patients overall with 20 patients assigned to receive treatment with the HA380 device. Any potential risks associated with the HA380 column will be monitored and managed appropriately throughout the study.
REC name
Wales REC 4
REC reference
24/WA/0104
Date of REC Opinion
29 May 2024
REC opinion
Further Information Favourable Opinion