Therapeutic Plasma Exchange in Patients With Acute Liver Failure: A Pilot Randomized Controlled Trial

Area of Science:

• Hepatology
• Critical Care Medicine
• Transplantation Science

Background:

• Acute liver failure (ALF) presents a critical medical emergency with high mortality rates.
• Liver transplantation (LT) is the primary definitive treatment for ALF.
• Previous studies on therapeutic plasma exchange (TPE) for ALF have produced conflicting survival outcomes.

Purpose of the Study:

• To evaluate the safety and efficacy of TPE in patients with ALF.
• To assess the impact of TPE on 30-day mortality in ALF patients.
• To analyze changes in biochemical markers and adverse events associated with TPE in ALF.

Main Methods:

• A single-center, open-label, pilot randomized controlled trial (RCT) involving 40 adults with ALF.
• Patients were randomized to standard medical therapy (SMT) alone or SMT plus TPE.
• TPE was administered daily for up to five days, with 30-day mortality as the primary outcome.

Main Results:

• Thirty-day mortality was 65% in both the SMT and TPE groups (intention-to-treat analysis, P=1.000).
• TPE recipients exhibited significant reductions in bilirubin and international normalized ratio by day 3, but survival remained unchanged.
• TPE was not independently associated with improved survival (HR: 0.92, 95% CI: 0.43-1.99, P=0.83).

Conclusions:

• Standard-volume TPE in ALF resulted in temporary biochemical improvements but did not enhance 30-day transplant-free survival.
• Larger, adequately powered multicenter RCTs are required to definitively ascertain the role of TPE in managing ALF.
• The study provides preliminary data on TPE's safety and biochemical effects in ALF.