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Phase 2 Withdrawn Montefiore Medical Center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

Outcome

Outcome not reported

Stopped (Enrollment): “PI confirmed that while coordination and planning was conducted upon IRB approval, no participants were enrolled into the study”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Albumin Protein / enzyme biologic 50 ml Intravenous
Subject Fresh Frozen Plasma (FFP) Protein / enzyme biologic 500 ml Intravenous

Indications