drugset / Trial / NCT04109144
Fresh Frozen Plasma as a Substitute for Albumin in Patients Receiving a Large Volume Paracentesis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Albumin | Protein / enzyme biologic | 50 ml | Intravenous |
| Subject | Fresh Frozen Plasma (FFP) | Protein / enzyme biologic | 500 ml | Intravenous |