Use of HA 330-II for Hemofiltration in Patients With ALF as a Bridge to Liver Transplantation .
Keywords
Abstract
Description
Since the 1960s, Liver Transplantation (LT) has emerged as a cornerstone intervention to cure liver failure. Mortality in patients with liver failure who cannot be rescued with Liver Transplantation remains high despite improvements in supportive care.
Artificial Liver Support System (ALSS) in ALF aim to remove excess inflammatory cytokines and attenuate inflammatory response, to remove albumin-bound and water-soluble toxins, to restore and preserve hepatic function and mitigate or limit the progression of multiorgan failure while hepatic recovery or liver transplant occurs. ALSS may also provide benefit in instances where LT is contraindicated.
The following beneficial effects have been documented with ALSS in ALF patients: improvement of jaundice, amelioration of hemodynamic instability, improvement of hepatic encephalopathy, SOFA score and survival.
HA 330-II is a broad-spectrum adsorbent made of neutral macroporous resin, removes toxins such as Inflammatory mediators (IL-1, IL-6, IL-8 & TNF-α) along with hepatic toxins such as phenol, mercaptan, aromatic amino acids, false neurotransmitters and indirectly ammonia by improving liver function recovery. However, this indirect ammonia removal with HA 330-II is insignificant. By removing excess inflammatory cytokines and attenuating uncontrolled immune response, HA 330-II prevents worsening of encephalopathy, improves liver function recovery and improves prognosis.
Dates
| Last Verified: | 12/31/2019 |
| First Submitted: | 01/16/2020 |
| Estimated Enrollment Submitted: | 01/23/2020 |
| First Posted: | 01/27/2020 |
| Last Update Submitted: | 01/23/2020 |
| Last Update Posted: | 01/27/2020 |
| Actual Study Start Date: | 12/29/2019 |
| Estimated Primary Completion Date: | 09/30/2020 |
| Estimated Study Completion Date: | 12/30/2020 |
Condition or disease
Intervention/treatment
Device: Hemoperfusion treatment with HA 330-II
Drug: Standard medical treatment (SMT)
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Hemoperfusion treatment with HA 330-II Hemoperfusion treatment with HA 330-II, one unit for 2-4 hours treatment, for 3 consecutive days along with SMT as per patients requirement. | Device: Hemoperfusion treatment with HA 330-II One unit for 2-4 hours treatment, for 3 consecutive days |
| Active Comparator: Standard medical treatment (SMT) SMT as per patients requirement- Management of cerebral edema/intracranial hypertension: prophylactic antibiotics, administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure, volume replacement and pressor support (noradrenaline, doubutamine, dopamine) as needed, NAC and correction of metabolic parameters. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: • Acute Liver Failure patients with SIRS and Hepatic Encephalopathy, without hyperbilirubinemia. Exclusion Criteria: - Patients with age less than 18 years or more than 65 years - Extremely moribund patients with an expected life expectancy of less than 24 hours or with poor prognosis - With poor blood clotting function and PTA <30%. - Active Bleed - Chronic heart, lung or kidney disease - Malignant tumors including liver cancer - Past history of organ transplantation |
Outcome
Primary Outcome Measures
1. Efficacy of HA 330-II to prolong liver-transplantation free survival. [Up to 30 Days]
Secondary Outcome Measures
1. Change in Systemic inflammatory response syndrome (SIRS) score. [Up to 7 Days, post hemofiltration]
2. Change in Acute Physiology and Chronic Health Evaluation (APACHE-II) score. [Up to 7 Days, post hemofiltration]
3. Change in sequential organ failure assessment (SOFA) score. [Up to 7 Days, post hemofiltration]
4. Change in chronic liver failure-sequential organ failure assessment (CLIF-SOFA) score. [Up to 7 Days, post hemofiltration]
