Health Condition 1: K720- Acute and subacute hepatic failure
Conditions
Interventions
Intervention1: Treatment with EBDLR System (Device): Treatment with EBDLR device for 10-12 hrs for 28 days in 4 sessions.
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Ykrita Life sciences Pvt Ltd.
Ardent Clinical Research Services
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients aged >18 years and 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 6 Mean arterial pressure of >60 mmHg (with or without inotropes) 7 International Normalized Ratio = 1.5 8 Serum Creatinine >1.5mg/dL
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 The percentage of patients who experience at least one serious adverse event(SAE) 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 to device administration 2 From Day 1 to Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Improvement in liver parameters 2 Patients who maintain good health for at least 4 consecutive days after disconnecting from the device. 3.Percent of patients who die during the procedures 4 Improvement in INR level 5 Percent of patients who undergo liver transplant during the treatment period 6 Percent of patients who gets discharged from the hospital 7 Percent of patients who gets discharged from the hospital Timepoint: 1 Baseline to Day 28(EOT) 2 at least 4 consecutive days after disconnecting from the device 4 baseline to Day 28 5 Baseline to Day-28 6 before Day 28 | — |
Countries
India
Contacts
Public ContactMr Chandu Devanpally
Ardent Clinical Research Services Pvt. Ltd.
Outcome results
None listed