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New blood filter aims to save lives in liver failure and sepsis

NCT ID NCT06562803

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study tests a special blood-filtering device (DPCAS+LPE) in 192 adults with acute-on-chronic liver failure and sepsis. The device removes harmful inflammatory substances from the blood. Researchers will compare survival rates and organ function between patients receiving this device plus standard care versus standard care alone. The goal is to see if this approach can reduce deaths within 4 and 12 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
double plasma cytokine adsorption system with sequential low-dose plasma exchange (DPCAS+LPE) device
What this could lead to
If successful, this could offer a new treatment option to improve survival in patients with severe liver failure complicated by sepsis.
What could go wrong
This is a mid-stage trial with 192 participants, so results may not apply to all patients. The device is complex and carries risks like bleeding or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 192 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age between 18 and 70 years with a background of chronic liver disease, regardless of the presence of cirrhosis. 2. Total bilirubin (TBIL) \> 12 mg/dL. 3. International normalized ratio (INR) ≥ 1.5. 4. Meeting the diagnostic criteria for sepsis: confirmed or suspected infection, with a sequential organ failure assessment (SOFA) score increase of ≥ 2 points. (5) High inflammatory status: IL-6 \> 80 pg/ml. (6) Diagnosis of sepsis within the past 72 hours. Exclusion Criteria: 1. Inherited metabolic liver disease (including Wilson's disease, hereditary hemochromatosis, and alpha-1 antitrypsin deficiency). 2. Patients with hepatocellular carcinoma or other malignancies. 3. Pregnant or breastfeeding women. 4. Patients with human immunodeficiency virus (HIV) infection or other immunodeficiency diseases (including active hematological malignancies, congenital immunodeficiency syndromes, or those currently receiving high-dose systemic immunosuppressive therapy). 5. Unstable phase of cerebrovascular events. 6. History of organ transplantation. 7. Patients with irreversible or terminal extrahepatic organ failure that precludes safe extracorporeal circulation or confounds the intervention: ①Terminal chronic obstructive pulmonary disease, terminal cor pulmonale, brain death, or persistent vegetative state, or Grade IV hepatic encephalopathy. ②Requirement for renal replacement therapy (RRT) at the time of screening/enrollment. ③Despite adequate fluid resuscitation, vasopressors, and steroid treatment, unable to maintain mean arterial pressure above 65 mmHg. 8. Platelet count \< 50×10E9/L, severe coagulation disorders (INR\>3.5), or active bleeding. 9. Known allergies to extracorporeal circulation, hemoperfusion, or other severe allergic history. 10. Refusal by the patient or their legally authorized representative (LAR) to participate in the study, or sign the informed consent form. 11. Inability to return for regular follow-up visits as planned in the study. 12. Other conditions that, in the judgment of the researchers, make the patient unsuitable for enrollment.

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Conditions

The condition(s) this trial relates to.

Acute-On-Chronic Liver Failure infectious disease with sepsis Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Third Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510630, China

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