ALSS - DPMAS and Therapeutic Plasma Exchange (TPE), Its Effect on Primary Coagulation, Inflammati… (NCT07329036) | Clinical Trial Compass
RecruitingNot Applicable
ALSS - DPMAS and Therapeutic Plasma Exchange (TPE), Its Effect on Primary Coagulation, Inflammation and the Function of Vital Organs in ALF or ACLF
Czechia25 participantsStarted 2024-04-01
Plain-language summary
The artificial liver support system (ALSS) in patients with acute on chronic liver failure - the use of combined molecular adsorption system with double plasma (DPMAS) and therapeutic plasma exchange (TPE), its effect on primary coagulation, inflammation and the function of vital organs.
Who can participate
Age range
18 Years – 75 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:
* Adult patient, age ≥18 years
* Expressed consent to the inclusion
* Patient hospitalized on ICU with ALF or ACLF diagnosis
* Recently meeting the inclusion to liver transplantation
* Present on a waiting list to liver transplant
* Unsuitable for inclusion to liver transplantation - indicated for support therapy only, but not indented to palliative care
Exclusion Criteria:
* Disagreement with the study
* Infaust prognosis with expected survival less than 24 hours
* Physiologically/biologically very advanced stage patients condition, severe lung disease (Gold criteria 3 or 4), heart failure (functional class NYHA III or IV) or neurological disease, as well as ACLF-3.
* Advanced oncological disease (expected life expectancy below 6 months)
* Severe degree of Frailty syndrome in secondary severe sarcopenia (muscle and malnutrition) or reduced performance state according
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
Transplant-Free Survival at Day 21
Timeframe: 21 days after the first ALSS (DPMAS/TPE) session
Trial details
NCT IDNCT07329036
SponsorInstitute for Clinical and Experimental Medicine