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.
NCT ID: NCT04015570
Last Updated: 2019-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2019-07-09
2020-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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High Volume Plasma Exchange with SMT
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)
High Volume Plasma Exchange
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
Standard Medical Treatment (Albumin+High caloric diet)
Standard Medical Treatment
Standard Medical Treatment (Albumin + High Caloric Diet)
Standard Medical Treatment
Standard Medical Treatment (Albumin+High caloric diet)
Interventions
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High Volume Plasma Exchange
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
Standard Medical Treatment (Albumin+High caloric diet)
Eligibility Criteria
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Inclusion Criteria
* Preferably Biopsy proven or history suggestive of DILI (Drug Induced Liver Injury)
1. Grade IV DILI With T.B \> 15
2. DILI Manifesting as ACLF (Acute on chronic Liver failure) /ALF (Acute Liver Failure) with no transplant option
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Locations
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Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Other Identifiers
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ILBS-Cirrhosis-24
Identifier Type: -
Identifier Source: org_study_id
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