190
Participants
Start Date
March 1, 2024
Primary Completion Date
December 31, 2027
Study Completion Date
December 31, 2027
Plasma Exchange
On day 1 Response assessment will be done to assess the need for a second session from day 3-7 and subsequently every week till day 28. A minimum of 3 sessions would be considered in the first seven days. The duration of each session would be 3-4 hours. Patients with partial response (not meeting criteria for a complete response after 3 sessions) would be considered for additional sessions as decided by the treating physician until desired complete response, adverse effects, liver transplant, death, or clinical futility. The complete response will be defined as a sustained reduction in bilirubin and international normalized ratio without any clinical worsening requiring discontinuation of therapy. Failure of therapy would be defined as the development of adverse effects, new onset sepsis, or organ failure. In such patients, further sessions would be deferred. Blood access was established with a double-lumen catheter inserted into the patient's femoral or jugular vein.
Standard Medical Treatment
Patients randomized to SMT Group will be given standard medical therapy (SMT) only included as per requirement.
Institute of Liver & Biliary Sciences, New Delhi
Institute of Liver and Biliary Sciences, India
OTHER