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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Volume Plasma Exchange with SMT | Experimental | 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) |
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| Standard Medical Treatment | Active Comparator | Standard Medical Treatment (Albumin + High Caloric Diet) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Volume Plasma Exchange | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Transplant free survival in both group | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Age-18-70 years
Preferably Biopsy proven or history suggestive of DILI (Drug Induced Liver Injury)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Satyam Sinha, MD | Contact | 01146300000 | satyamsinhacmc5@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences | Recruiting | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| Standard Medical Treatment | Other | Standard Medical Treatment (Albumin+High caloric diet) |
|
| Number of participants with the development of organ dysfunction or failure in both group | Day 28 |