NCT04051437

Brief Summary

Acute on chronic liver failure (ACLF) is a distinct syndrome in patients with chronic liver disease with rapid clinical deterioration and has high short term mortality within one month.Despite aggressive clinical care, only half of the patients could survive an episode of ACLF. The investigators hypothesized that the early treatment with therapeutic plasma exchange with plasma and albumin in ACLF patients might improve overall survival in carefully selected patients by removing cytokines, chemokines and toxic substances.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2019

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

August 15, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

8 months

First QC Date

August 3, 2019

Last Update Submit

August 8, 2019

Conditions

Cirrhosis, LiverAcute-On-Chronic Liver Failure

Keywords

Plasma exchangeAcute on chronic liver failure

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    90 days

Secondary Outcomes (4)

  • Transplant free survival

    90 days

  • Development of organ dysfunction

    28 days

  • Development of cirrhosis complications

    28 days

  • Improvement in Model for end stage liver disease score

    90 days

Study Arms (2)

Plasma exchange

EXPERIMENTAL

The consented patients will receive standard medical management with sessions of single volume plasma exchange with fresh frozen plasma and 5% human albumin.Plasma exchange session will be done on an alternate day to a maximum of 5 procedures.

Procedure: Plasma exchange

Standard medical treatment

ACTIVE COMPARATOR

The consented patients will receive standard medical treatment which includes adequate nutrition (35-45 Kcal/Kg with 1.5gm/Kg protein) diuretics, anti HE measures, appropriate antibiotics for infections, entecavir 0.5 mg once daily for hepatitis B, and steroids for autoimmune hepatitis.

Drug: Standard medical treatment

Interventions

Plasma exchangePROCEDURE

During each plasma exchange session 3-4lt (1.2-1.3 times of plasma volume) of plasma will be exchanged with fresh frozen plasma and 5% albumin. Plasma exchange session will be done on an alternate day to a maximum of 5 procedures. PLEX will be discontinued if the patients Shows sustained clinical improvement, Receive liver transplantation, Refuses further PLEX session No improvement in clinical condition Intolerant to PLEX procedure

Plasma exchange
Standard medical treatmentDRUG

The consented patients will receive standard medical treatment which includes adequate nutrition (35-45 Kcal/Kg with 1.5gm/Kg protein) diuretics, anti HE measures, appropriate antibiotics for infections,tablet entecavir 0.5 mg once daily for hepatitis B, and steroids for autoimmune hepatitis.

Standard medical treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with ACLF as per APASL criteria with AARC score of ≥8

You may not qualify if:

  • Uncontrolled sepsis
  • Septic shock requiring inotropes despite fluid resuscitation
  • Active or recent bleeding (unless controlled for \>48 hours).
  • Severe thrombocytopenia (≤20×10\^9/L)
  • Acute kidney injury with Creatinine \> 2 or the need of RRT
  • Respiratory failure (Severe ARDS)
  • Chronic kidney disease
  • Hepatocellular carcinoma outside Milan criteria (1 nodule ≤5 cm or 3 nodules ≤3 cm)
  • HIV infection
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver CirrhosisAcute-On-Chronic Liver Failure

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsLiver Failure, AcuteLiver FailureHepatic Insufficiency

Intervention Hierarchy (Ancestors)

Blood TransfusionBiological TherapyTherapeuticsPlasmapheresisBlood Component RemovalSorption DetoxificationExtracorporeal CirculationSurgical Procedures, Operative

Central Study Contacts

Pramod Kumar, MD

CONTACT

+91-9814933544dapramod@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 3, 2019

First Posted

August 9, 2019

Study Start

August 15, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

August 9, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share