An innovative clinical trial is now recruiting participants to assess the effectiveness of the artificial liver support system (ALSS) using dual plasma molecular adsorption system (DPMAS) and therapeutic plasma exchange (TPE) in acute liver failure (ALF) and acute-on-chronic liver failure (ACLF). Sponsored by the Institute for Clinical and Experimental Medicine, this trial aims to evaluate the impact of these technologies on primary coagulation, inflammation, and vital organ function. This groundbreaking investigation highlights developments in medical device-assisted treatment for critical hepatic conditions.
What is the focus of this study?
The trial centers on assessing the combined effects of dual plasma molecular adsorption system (DPMAS) and therapeutic plasma exchange (TPE) used in the artificial liver support system. These devices aim to alleviate the complications of acute liver failure, including issues related to coagulation and inflammation, while supporting vital organ function.
How does the artificial liver support system work?
The artificial liver support system functions by using advanced plasma exchange and adsorption techniques to remove toxins, stabilize coagulation, and reduce systemic inflammation in patients with severe liver damage. DPMAS uses molecular adsorption technology to clean the blood by targeting specific harmful substances, while TPE adds broad plasma filtration to further detoxify the circulatory system, improving patient stability.
Who benefits from this investigation?
The patient populations most likely to benefit from this trial are those suffering from acute liver failure (ALF) or acute-on-chronic liver failure (ACLF). ALF is a sudden and severe liver malfunction in individuals without pre-existing liver disease, while ACLF occurs in patients with pre-existing chronic liver damage. Both present critical challenges, including coagulopathy and organ dysfunction, that this trial aims to address.
What are the objectives of the trial?
The study will evaluate the efficacy and safety of DPMAS and TPE treatments by measuring their impact on three key areas:
- Primary coagulation markers: to determine improvements in blood-clotting abilities.
- Inflammation reduction: targeting pro-inflammatory mediators responsible for systemic effects.
- Vital organ performance: assessing functions including renal, pulmonary, and cardiovascular systems.
The trial also aims to build clinical evidence and refine algorithms for treating severe hepatic conditions using devices compliant with international health regulations.
FAQ
- What is a dual plasma molecular adsorption system (DPMAS)?
DPMAS is a medical technology that removes harmful substances from the blood through molecular adsorption processes. - How is therapeutic plasma exchange (TPE) different from DPMAS?
TPE removes and replaces a patient’s plasma to eliminate inflammatory triggers and toxins, complementing DPMAS technology. - Is this trial currently recruiting participants?
Yes, the announced trial is recruiting eligible participants as of the most recent update. - Who sponsors this clinical investigation?
The Institute for Clinical and Experimental Medicine is the trial sponsor.
Conclusion
The launch of this clinical trial marks an important step in advancing life-saving technologies for patients with acute and chronic liver failure. By investigating the impact of innovative devices such as DPMAS and TPE, healthcare providers may soon have new evidence-based tools to improve outcomes in critical care settings. Stakeholders in clinical treatment, quality assurance, and regulatory monitoring are encouraged to follow these developments closely.
Disclaimer
This article provides general information about a clinical trial and should not be taken as medical or legal advice. For specifics, consult the official trial sponsor or regulatory guidelines.
More information
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07329036?term=medical+device