Using HA380 blood filter in critically ill patients needing extracorporeal support
HA380 Column Use in Critically Ill Patients Receiving Extracorporeal Support for Acute Critical Illness; a Prospective, Randomised, Interventional, Feasibility, Pilot Study (HACEC)
This study is testing whether a new blood filter can help critically ill patients on dialysis or ECMO recover faster by reducing inflammation and improving their overall care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospitals, Leicester Academic / other |
| Locations | 1 site (Leicester, Leicestershire) |
| Trial ID | NCT06179771 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with sepsis, trauma, or ARDS who need extracorporeal support within 72 hours of admission.
Not a fit: Patients with pre-existing chronic kidney disease, severe respiratory failure, or those expected to die within 24 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster recovery times and improved outcomes for critically ill patients requiring extracorporeal support.
How similar studies have performed: Previous studies using cytokine adsorption devices have shown promise, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Leicester, Leicestershire
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.