Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06179771

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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