Multiple Organ Failure Clinical Trial
— MexACLFOfficial title:
Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in Acute on Chronic Liver Failure (ACLF)
Verified date | May 2024 |
Source | Mexbrain |
Contact | Karen GILLANT |
Phone | +33674152663 |
Karen.gillant[@]MEXBRAIN.COM | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 copper from the blood? Patients will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week.
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | March 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Male or female subjects =18 years and =80 years - Subject is able to provide informed consent to participate in the study, otherwise written consent must be obtained on behalf of the subject by a next of kin or legal representative in accordance with local ethical and legal requirements - History of an acute decompensation event (including but not limited to ascites, gastrointestinal bleeding, hepatic encephalopathy and/or acute bacterial infections), occurring within =6 weeks of screening - Cirrhosis (diagnosed based on clinical, biological, morphological parameters or liver biopsy) - Subject with: - ACLF Grade 2, 3a or 3b based on the CLIF-C OF score - Under continuous renal replacement therapy (CRRT) or any organ support device that requires catheter placement Exclusion Criteria: - Subjects with acute or sub-acute liver failure without an underlying cirrhosis - Subjects not considered appropriate for full active treatment including organ support or those with a Do Not Attempt Cardio-Pulmonary Resuscitation order (DNACPR) - Subjects who have received any investigational drug or device within 30 days of dosing or who are scheduled to receive another investigational drug or device in the course of the study; concomitant observational studies are allowed - Evidence of uncontrolled seizures - In females: known pregnancy or lactating - Patients with a known allergy to shellfish - Patients for who, in the opinion of the investigator, it would be unsafe to be considered for the study - Vulnerable population according to Articles 64 to 68 of the Regulations (EU) 2017/745 on Medical Devices - Patient with weight < 30 kg |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie | Lyon | Rhône-Alpes |
Lead Sponsor | Collaborator |
---|---|
Mexbrain | Slb Pharma |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SADE for Safety purpose | The safety will be assessed by percentage of subjects who discontinued MexACLF due to a serious adverse device event (SADE) between Day 1 and Day 7. | From the enrollment until the last visit, assessed up to 7 days. | |
Secondary | SAE for Safety purpose | The safety will be assessed by the percentage of patients who experience at least one related Serious Adverse Event (SAE) between Day 1 and Day 7. | From the start of the first MEX-CD1 treatment until the last visit, assessed up to 7 days. | |
Secondary | Performance of MEX-CD1 | The performance of the MEX-CD1 slow low-volume CVVHD treatment in terms of iron extraction will be measured by the amount of iron extracted in the dialysate bags per treatment. | 3 hours and 20 minutes; from treatment start (0 hours) to treatment end (3h20) | |
Secondary | Change in Acute on Chronic Liver Failure (ACLF) Grade | Assessment of the change in ACLF Grade between the baseline and the end of study Min value = 0 (no ACLF) Max value=3b (Worse outcome) | Between the screening visit and the last visit, assessed up to 7 days. | |
Secondary | Change in CLIF-C ACLF score | Assessment of the change in Chronic Liver Failure-Consortium (CLIF-C) ACLF score between the baseline and the end of study. CLIF-C ACLF = 10 × (0.33 × CLIF-C OFs + 0.04 x Age + 0.63 × ln (WBC count)-2)
CLIF-OFs= Chronic Liver Failure Consortium Organe Failure Min value=6 (No organe Failure) Max value=18 (6 organe failures) |
Between the screening visit and the last visit, assessed up to 7 days. | |
Secondary | Improvement in individual organ function | Assessment of the change in individual organ function by using the CLIF sequential OF score
From 1 (no organe failure) to 3 (worse outcome) for the 6 organes below: Liver ; kidney ; Brain ; Coagulation ; Circulation ; Respiratory |
Between the screening visit and the last visit, assessed up to 7 days. | |
Secondary | Development of secondary infection | Assessment of development of secondary infection by need for new antibiotic therapy | Between the screening visit and the last visit, assessed up to 7 days. | |
Secondary | Status of ICU | Length of stay in ICU | Between the screening visit and the last visit, assessed up to 28 days. | |
Secondary | hospital discharge | Length of stay at hospital | Between the screening visit and the last visit, assessed up to 28 days. | |
Secondary | Mortality | Assessment of the survival rate | Between the screening visit and the last visit, assessed up to 28 days. |
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