Efficacy and Safety of Plasma Exchange Compared to Standard Medical Therapy in Patients With Severe Drug Induced Liver Injury With or Without Underlying Chronic Liver Disease.
A Randomized Controlled Trial to Study the Efficacy and Safety of Plasma Exchange Compared to Standard Medical Therapy in Patients With Severe Drug Induced Liver Injury With or Without Underlying Chronic Liver Disease.
1 other identifier
interventional
30
1 country
1
Brief Summary
In this randomized study subject will be randomized into two groups Group A will receive Standard Medical Treatment (Albumin + High Caloric Diet) Group B will continue Standard Medical Treatment with High Volume Plasma Exchange. All other interventions will be at the discretion of clinicians.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2019
1 active site
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
July 8, 2019
CompletedStudy Start
First participant enrolled
July 9, 2019
CompletedFirst Posted
Study publicly available on registry
July 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedJuly 11, 2019
July 1, 2019
12 months
July 8, 2019
July 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Transplant free survival in both group
Day 28
Secondary Outcomes (3)
Number of participants with the development of organ dysfunction or failure in both group
Day 7
Number of participants with the development of organ dysfunction or failure in both group
Day 15
Number of participants with the development of organ dysfunction or failure in both group
Day 28
Study Arms (2)
High Volume Plasma Exchange with SMT
EXPERIMENTALPLASMA EXCHANGE is therapeutic procedure in which blood of the patient is passed through a medical device which separates plasma from other components of blood. The plasma is removed and replaced with a replacement solution such as colloid solution (e.g., albumin and/or plasma) or a combination of crystalloid/colloid solution.Plasma exchange leads to removal of abnormal circulating plasma factor or a physiologic factor produced in excess (IG, NH3,protein bond toxins )and also exert a immunomodulatory activity. Standard Medical Treatment (Albumin + High Caloric Diet)
Standard Medical Treatment
ACTIVE COMPARATORStandard Medical Treatment (Albumin + High Caloric Diet)
Interventions
PLASMA EXCHANGE is therapeutic procedure in which blood of the patient is passed through a medical device which separates plasma from other components of blood. The plasma is removed and replaced with a replacement solution such as colloid solution (e.g., albumin and/or plasma) or a combination of crystalloid/colloid solution.Plasma exchange leads to removal of abnormal circulating plasma factor or a physiologic factor produced in excess (IG, NH3,protein bond toxins )and also exert a immunomodulatory activity
Standard Medical Treatment (Albumin+High caloric diet)
Eligibility Criteria
You may qualify if:
- Age-18-70 years
- Preferably Biopsy proven or history suggestive of DILI (Drug Induced Liver Injury)
- Grade IV DILI With T.B \> 15
- DILI Manifesting as ACLF (Acute on chronic Liver failure) /ALF (Acute Liver Failure) with no transplant option
You may not qualify if:
- Evidence of active infection
- Refusal of consent or assent
- Patients with clinical suspicion of irreversible brain injury
- Pregnancy
- HCC (Hepatocellular Carcinoma) or any other malignancy
- Kidney failure
- Portal vein thrombosis
- Upper GastroIntestinal bleed
- Transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2019
First Posted
July 11, 2019
Study Start
July 9, 2019
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
July 11, 2019
Record last verified: 2019-07