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Clinical Trials/CTRI/2024/02/062612
CTRI/2024/02/062612
Recruiting
Phase 1

A multi-Centre, single arm study to evaluate the safety tolerability and performance of The Extracorporeal Bioengineered Dual-Cell Liver Regeneration System [EBDLR System] in patients suffering from Acute Liver Failure (ALF) - NI

Ykrita Life sciences Pvt Ltd.0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: K720- Acute and subacute hepatic failure

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Health Condition 1: K720- Acute and subacute hepatic failure
Sponsor
Ykrita Life sciences Pvt Ltd.
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Ykrita Life sciences Pvt Ltd.

Eligibility Criteria

Inclusion Criteria

  • •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

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 \<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

Outcomes

Primary Outcomes

Not specified

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