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

NCT03202524 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-06-14

No results posted yet for this study

Summary

Large volume paracentesis 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 demonstrate if the administration of fresh frozen plasma (FFP) is as effective as albumin for volume expansion at the time of a large volume paracentesis.

Conditions

Interventions

BIOLOGICAL

Fresh Frozen Plasma (FFP)

FFP will be used as a substitute for albumin for the prevention of post-paracentesis circulatory dysfunction.

BIOLOGICAL

Albumin

Albumin will be used for the prevention of post-paracentesis circulatory dysfunction, as is the standard of care

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Samuel Sigal, MD · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-31
Primary Completion
2018-07-31
Completion
2018-07-31
FDA Drug
Yes

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Entities

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 NCT03202524 on ClinicalTrials.gov