Actively Recruiting
Pilot Study on HA380 Column Use in Critically Ill Patients Receiving Extracorporeal Support.
Led by University Hospitals, Leicester · Updated on 2026-03-02
40
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients who are very ill either due to a severe infection, major organ injury, trauma or a major operation may require significant support with devices such as a dialysis machine for the kidneys or Extracorporeal Membrane Oxygenation (ECMO) for the heart and lungs. This is often due to a reaction of the body to the insult which is termed inflammation. The investigators would like to assess if the use of a device that can remove the agents driving this reaction can lead to a quicker recovery form the illness. The device is a blood filter called HA380 and it would be connected to either the dialysis machine or the ECMO circuit. The investigators want to assess the feasibility of conducting a study with the HA380 column. We will also evaluate if the use of the HA380 column has an effect on the time spent on dialysis or ECMO, time spent on the breathing machine, time spent requiring drugs to support blood pressure and time spent in the intensive care unit.
CONDITIONS
Official Title
Pilot Study on HA380 Column Use in Critically Ill Patients Receiving Extracorporeal Support.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Consent obtained
- Male or Female, aged 18 years - 65 years
- Admitted with a diagnosis of sepsis (according to sepsis-3 definition), trauma, ARDS of infectious or non-infectious cause, trauma, or after major surgery
- Need for extracorporeal support specifically renal replacement therapy (RRT) and/or ECMO
- Requirement for vasopressor or inotropic therapy at time of RRT or ECMO support
- Within 72 hours of starting extracorporeal support
- At least one of the following: CRP > 100 mg/L (without immunosuppressive therapy/immunomodulation) or Lactate > 2 mmol/L
You will not qualify if you...
- Unable to provide consent
- Expected to die within the next 24 hours
- Pre-existing chronic kidney disease requiring dialysis or eGFR < 30 ml/min/1.73m2
- Pre-existing severe respiratory failure requiring home oxygen, nebulisers, or with poor exercise tolerance
- Chronic heart failure NYHA class III or higher
- Pregnancy
- Need for immediate immune modulation such as plasma exchange, high dose steroids, or IV immunoglobulins (excluding vasoplegic dose steroids or immune modulation for COVID-19)
- Participation in another research trial involving an investigational product within the past 12 weeks
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom, LE3 9QP
Actively Recruiting
Research Team
H
Hakeem Yusuff, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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