drugset / Trial / NCT04109144

Fresh Frozen Plasma as a Substitute for Albumin in Patients Receiving a Large Volume Paracentesis

NCT04109144

Phase 2 Withdrawn Montefiore Medical Center
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Large volume paracentesis (LVP) with albumin administration is the standard of care for patients with refractory ascites complicating end-stage liver disease. However, the use of albumin is frequently limited due to expense and occasional short supply. The goal of this study is to determine if the administration of Fresh Frozen Plasma (FFP) during large volume paracentesis is effective in lowering plasma renin activity by 25% compared to baseline.

Timeline

Start
2019-11-11
Primary completion
2023-07
Completion
2023-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Albumin Protein / enzyme biologic 50 ml Intravenous
Subject Convalescent Plasma Protein / enzyme biologic 500 ml Intravenous

Indications