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 and the Function of Vital Organs.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Transplant-Free Survival at Day 21
研究概览
简要总结
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.
详细描述
In patients with ACLF we assume the use of the proposed protocol of combined support therapy (consisting of a hemoadsorption system - DPMAS (double plasma molecular absorption system) and therapeutic plasma (TPE), with the basic aim of improving clinical condition (organ dysfunction) to allow the regeneration of liver parenchyma or to perform liver transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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-
- •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
研究组 & 干预措施
ALSS (alternating DPMAS and TPE)
Participants meeting inclusion criteria will receive artificial liver support system (ALSS) therapy in addition to standard of care. ALSS sessions will be performed for up to 7-10 days or until liver transplantation or recovery of hepatic function, whichever occurs first. ALSS modalities will be alternated according to protocol (DPMAS and TPE alternating between sessions). Outcomes will be assessed through Day 28 after hospital admission (or per protocol).
干预措施: The artificial liver support system (ALSS) - DPMAS/TPE (Device)
Standard care
Participants will receive standard of care for ACLF according to institutional protocol without ALSS (no DPMAS and no TPE as part of ALSS).
结局指标
主要结局
Transplant-Free Survival at Day 21
时间窗: 21 days after the first ALSS (DPMAS/TPE) session
Proportion of patients with acute liver failure who are alive without liver transplantation at Day 21 after initiation of artificial liver support therapy (combined DPMAS + TPE).
次要结局
- Overall Survival at Day 21(21 days after the first ALSS session)
- Overall Survival at Day 90(90 days after the first ALSS session)
- Liver Transplantation Rate and Timing(Up to 90 days after the first ALSS session)
研究者
Petr Piza
anesthesiologist/intensivist
Institute for Clinical and Experimental Medicine