An Open-label Randomized Controlled Trial Comparing the Role of Therapeutic Plasma-exchange in Ameliorating Secondary Organ Dysfunctions in Patients With ACLF and Develop Biomarkers of Treatment Response

NANot yet recruitingINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

March 1, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Acute on Chronic Liver Failure
Interventions
BIOLOGICAL

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.

OTHER

Standard Medical Treatment

Patients randomized to SMT Group will be given standard medical therapy (SMT) only included as per requirement.

Trial Locations (1)

110070

Institute of Liver & Biliary Sciences, New Delhi

All Listed Sponsors
lead

Institute of Liver and Biliary Sciences, India

OTHER

NCT06276907 - An Open-label Randomized Controlled Trial Comparing the Role of Therapeutic Plasma-exchange in Ameliorating Secondary Organ Dysfunctions in Patients With ACLF and Develop Biomarkers of Treatment Response | Biotech Hunter | Biotech Hunter