Using HA380 blood filter in critically ill patients needing extracorporeal support

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the use of the HA380 blood filter in critically ill patients who require extracorporeal support, such as dialysis or ECMO, due to severe infections, organ injuries, or major surgeries. The goal is to determine if this device can reduce inflammation and improve recovery times by filtering harmful agents from the blood. Researchers will assess the feasibility of using the HA380 column and its impact on the duration of dialysis or ECMO, the need for blood pressure support, and overall time spent in intensive care. The study focuses on patients who are experiencing severe inflammatory responses and may benefit from this innovative approach.

Why it matters

Who can join: the full rules

Inclusion Criteria

* 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 aetiology, trauma or after major surgery
* Need for extracorporeal support and specifically renal replacement therapy (RRT) and/or ECMO.
* Vasopressor or inotropic therapy requirement at the time of RRT or ECMO support
* Within 72 hours of requiring extracorporeal support
* At least one of:
* CRP \> 100 mg/L (in the absence of immunosuppressive therapy/immunomodulation)
* Lactate \>2 mmol/L

Exclusion Criteria

* The participant may not enter the trial if ANY of the following apply:
* Unable to obtain consent.
* Expected to die in the next 24 hours.
* Pre-existing chronic kidney disease - requiring dialysis /eGFR \< 30ml/min/1.73m2
* Pre-existing severe respiratory failure - e.g., requiring home oxygen/ home nebulisers/ poor exercise tolerance
* Chronic heart failure - NYHA class III and above
* Pregnancy
* Requirement for immediate immune modulation e.g., plasma exchange, high dose steroids , IV immunoglobulins (does not include vasoplegic dose of steroids or immune modulation for COVID 19)
* Participants who have participated in another research trial involving an investigational product in the past 12 weeks.

Where it's running

• University Hospitals of Leicester NHS Trust
  Leicester, Leicestershire, United Kingdom Recruiting

Study contacts

• Study coordinator: Hakeem Yusuff, MBBS
• Email: hakeem.yusuff1@nhs.net
• Phone: 01162583816

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.