To evaluate the safety tolerability and performance of the liver assist device (EBDLR System) in patients suffering from Acute Liver Failure
- Conditions
- Health Condition 1: K720- Acute and subacute hepatic failure
- Registration Number
- CTRI/2024/02/062612
- Lead Sponsor
- Ykrita Life sciences Pvt Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1 Patients aged >18 years and <65 years both the genders
2 Patients or LAR /IW able to provide informed consent voluntarily to participate in the study
3 Patients diagnosed with ALF of known/unknown etiology
4 Acute liver failure, defined as the development of coagulopathy (International normalized ratio [INR] =1.5) with encephalopathy in a patient with no prior history of liver disease with onset of symptoms within 28 days of the inciting event
5 Patients may have either a history of acetaminophen overdose (defined as >4 g/day within 7 days of presentation) and/or detectable acetaminophen levels in the serum with a pattern of liver function tests typical for acetaminophen toxicity (bilirubin <10 mg/dL and alanine aminotransferase (ALT) =1000 IU/L) or a diagnosis of hepatitis A hepatitis B drug induced liver injury autoimmune hepatitis or indeterminate cause based on standard criteria
6 Mean arterial pressure of >60 mmHg (with or without inotropes)
7 International Normalized Ratio = 1.5
8 Serum Creatinine >1.5mg/d
1 History of chronic liver disease
2 Signs of overt cerebral herniation, or uncontrolled intracranial hypertension by ICP monitoring
3 Significant gastrointestinal bleeding (coffee grounds per ng tube and/or melena)
4 Hemodynamic instability defined by a mean arterial pressure of <60 mmHg
5 Cardiopulmonary complications such as pulmonary edema aspiration pneumonia heart failure QT interval of >500msec at baseline ECG
6 Pregnancy
7 History of malignancy that has not been cured or any cancer in remission for less than 1 year Nonmelanoma skin cancers do not preclude participation in the trial
8 Any other health condition that would preclude participation in the study in the judgment of the site principal investigator
9 Patients with HCC outside Milan criteria
10 Patients who do not support DNACPR
11 Patients with a known allergy to heparin or have type II thrombocytopenia caused by heparin
12 In the opinion of the investigator the patient is unsafe for the study can be excluded
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 The percentage of patients who experience at least one <br/ ><br>serious adverse event(SAE) <br/ ><br>2.The percentage of patients who needs to discontinue EBDLR device due to any adverse/ serious adverse device events(AE/SAE)Timepoint: 1 baseline to Day-28 due <br/ ><br>to device administration <br/ ><br>2 From Day 1 to Day 28
- Secondary Outcome Measures
Name Time Method 1 Improvement in liver parameters <br/ ><br>2 Patients who maintain good health for at least 4 consecutive days after <br/ ><br>disconnecting from the device. <br/ ><br>3.Percent of patients who die during the procedures <br/ ><br>4 Improvement in INR level <br/ ><br>5 Percent of patients who undergo liver transplant during the treatment period <br/ ><br>6 Percent of patients who gets discharged from the hospital <br/ ><br>7 Percent of patients who gets discharged from the hospital <br/ ><br>Timepoint: 1 Baseline to Day 28(EOT) <br/ ><br>2 at least 4 consecutive days after disconnecting from the device <br/ ><br>4 baseline to Day 28 <br/ ><br>5 Baseline to Day-28 <br/ ><br>6 before Day 28 <br/ ><br> <br/ ><br>