NCT04109144

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

There will be three periods of this study, one for each of three consecutive routine large volume paracenteses. The length of the study will be 6 days post paracentesis for each period, for a total of 3 periods. The interval between successive LVP's will be determined by patients' need. In order to ensure follow up on Day 6, Day 1 will be restricted to a Tuesday, Wednesday, Thursday, or Friday. All participants will be monitored for 3 consecutive routine large volume paracenteses. The 3 periods (LVP's) of this study will differ in administration of volume replacement solution. First LVP will be with intravenous albumin (12.5gm 25% Human Albumin for every 2 liters removed), 2nd LVP with administration 1 unit of FFP for every 2 liters removed for the first 4 liters followed by 12.5gm 25% albumin for every subsequent 2 liters removed, and 3rd LVP again with administration of intravenous albumin. The first LVP serves as the study entry time period and also as a control period for the same patient. The second LVP is to test the new intervention with FFP. The third LVP is included so that we can monitor the patient's status. Albumin or FFP administration: Albumin administration: 50ml of 25% albumin for every 2L removed FFP administration: 2 units of FFP for the first 4L removed followed by 50ml of 25% albumin for every additional 2L removed FFP will be supplied by the Blood Bank and albumin from the pharmacy at Montefiore Medical Center. Details for each study period: 1. st Period: Day 1: Enrollment, baseline pre-LVP laboratory testing and measurements, and large volume paracentesis with administration of albumin Day 6: Laboratory testing and measurements 2. nd Period: Day 1: pre-LVP baseline labs and measurements, LVP with FFP administration Day 6: Laboratory testing and measurements 3. rd Period: Day 1: pre-LVP baseline labs and measurements, LVP with albumin administration Day 6: Laboratory testing and measurements

Conditions

• Liver Cirrhosis
• Ascites Hepatic

Interventions

Type	Name	Description
BIOLOGICAL	Fresh Frozen Plasma (FFP)	FFP will be used as a substitute for albumin during the 2nd of 3 total paracentesis being monitored
BIOLOGICAL	Albumin	Albumin will be used during the 1st and 3rd paracentesis
PROCEDURE	Large Volume Paracentesis (LVP)	All participants who have this procedure, meet eligibility criteria and who consent

Timeline

• Start date: 2019-11-11
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2019-09-30
• Last updated: 2022-08-25

Regulatory

• FDA-regulated drug study