Pilot Study on HA380 Column Use in Critically Ill Patients Receiving Extracorporeal Support. (NCT06179771) | Clinical Trial Compass
RecruitingNot Applicable
Pilot Study on HA380 Column Use in Critically Ill Patients Receiving Extracorporeal Support.
United Kingdom40 participantsStarted 2024-09-02
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Successful use of HA380 column in critically ill patients.
Timeframe: through study completion, an average of 24 months
2
Ability to recruit the sample size of eligible patients within the study period.
Timeframe: through study completion, an average of 24 months