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

NCT04109144 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-08-25

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Samuel Sigal, MD · Montefiore Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-11
Primary Completion
2023-07-31
Completion
2023-07-31
FDA Drug
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04109144 on ClinicalTrials.gov