Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340269
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-03-25
Brief Title:
Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in ACLF
Sponsor:
Mexbrain
Organization:
Mexbrain
Study Overview
Official Title:
Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in Acute on Chronic Liver Failure ACLF
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MexACLF
Brief Summary:
The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from ACLF The main questions it aims to answer are
Is the device safe when used according to the instructions for use
Does the device work as expected by removing the excess of free iron from the blood
Patients will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week
Is the device safe when used according to the instructions for use
Does the device work as expected by removing the excess of free iron from the blood
Patients will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week
Detailed Description:
This study investigates the safety and performance of the MEX-CD1 slow low volume CVVHD device in patients suffering from ACLF
Acute-on-chronic liver failure ACLF is defined as a syndrome in patients with acutely decompensated cirrhosis associated with single or multiple organ failures and characterized by a high short-term mortality ACLF is frequently triggered by a precipitating event alcoholic hepatitis infection gastrointestinal haemorrhage and characterized by an intense systemic inflammatory response driven per pathogen-associated molecular patterns PAMPs andor damage-associated molecular patterns DAMPs responsible of the development of organs failure through tissues hypoperfusion immune-mediated tissue damages and mitochondrial dysfunction
Very importantly ACLF is a very dynamic syndrome that has potential for reversibility It is hypothesized that the extraction of non-transferrin bound iron NTBI could break down the vicious cycle of the excessive inflammatory responses reduce oxidative stress and inhibit pathogen proliferation in ACLF patients
As a consequence it is hypothesized that the extraction of NTBI could promote improvement of ACLF grade n to ACLF grade n-1 or no ACLF It is hypothesized that the extraction of NTBI could stop the progression of ACLF by preventing further organ failures and by reducing bacterial infection Thereby the extraction of NTBI could restore the eligibility of ACLF patients to liver transplantation and with or without liver transplantation allow an earlier discharge from intensive care and prolong survival
The proposed medical device by combining dialysis to a hyper-chelating colloidal dialysate MEX-CD1 specifically extracts free iron from the blood
All patients enrolled in this study will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week The duration of each MEX-CD1 Slow Low volume CVVHD session is 3h20
Acute-on-chronic liver failure ACLF is defined as a syndrome in patients with acutely decompensated cirrhosis associated with single or multiple organ failures and characterized by a high short-term mortality ACLF is frequently triggered by a precipitating event alcoholic hepatitis infection gastrointestinal haemorrhage and characterized by an intense systemic inflammatory response driven per pathogen-associated molecular patterns PAMPs andor damage-associated molecular patterns DAMPs responsible of the development of organs failure through tissues hypoperfusion immune-mediated tissue damages and mitochondrial dysfunction
Very importantly ACLF is a very dynamic syndrome that has potential for reversibility It is hypothesized that the extraction of non-transferrin bound iron NTBI could break down the vicious cycle of the excessive inflammatory responses reduce oxidative stress and inhibit pathogen proliferation in ACLF patients
As a consequence it is hypothesized that the extraction of NTBI could promote improvement of ACLF grade n to ACLF grade n-1 or no ACLF It is hypothesized that the extraction of NTBI could stop the progression of ACLF by preventing further organ failures and by reducing bacterial infection Thereby the extraction of NTBI could restore the eligibility of ACLF patients to liver transplantation and with or without liver transplantation allow an earlier discharge from intensive care and prolong survival
The proposed medical device by combining dialysis to a hyper-chelating colloidal dialysate MEX-CD1 specifically extracts free iron from the blood
All patients enrolled in this study will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week The duration of each MEX-CD1 Slow Low volume CVVHD session is 3h20
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None