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

June 12, 2019 updated by: Montefiore Medical Center
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 years or older
  2. Cirrhosis of the liver based on biopsy or clinical and radiographic criteria
  3. Ability to provide informed consent (Grade 0 to 1 HE)
  4. Grade 3 ascites or refractory ascites
  5. Ascites requiring frequent large volume paracentesis of at least 5 liters at least once a month
  6. No diuretic use

Exclusion Criteria:

  1. Inability to obtain informed consent
  2. Age less than 18
  3. Hepatic Encephalopathy Grade > 1
  4. Septic shock
  5. Active infection
  6. Respiratory failure
  7. Heart failure with reduced ejection fraction of ≤ 50%
  8. Moderate or severe pulmonary hypertension
  9. History of stroke
  10. Unstable coronary artery disease
  11. Chronic kidney disease (GFR <60)
  12. GI bleed within 2 weeks
  13. Any licorice within 2 weeks of starting the study
  14. Any Beta Blocker use within the last 2 weeks
  15. Any diuretic use within 2 weeks
  16. Absence of paracentesis within 2 weeks
  17. Absence of volume expanders within 2 weeks
  18. INR > 1.7

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Albumin
Patients undergoing large volume paracentesis with receive 50ml of 25% albumin for every 2 L removed from their abdomen.
Biological: Albumin
Albumin will be used for the prevention of post-paracentesis circulatory dysfunction, as is the standard of care
EXPERIMENTAL: Fresh Frozen Plasma
Patients undergoing large volume paracentesis with receive 2 units of FFP for the first 4L removed followed by 50ml of 25% albumin for every additional 2 L removed
Biological: Fresh Frozen Plasma (FFP)
FFP will be used as a substitute for albumin for the prevention of post-paracentesis circulatory dysfunction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Post-Paracentesis Circulatory Dysfunction (PPCD)
Time Frame: 6 Days
The development of PPCD is diagnosed by an increase in plasma renin activity of more than 50% of baseline to > 4 ng/mL/h on the 6th day post paracentesis
6 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2017

Primary Completion (ANTICIPATED)

July 1, 2018

Study Completion (ANTICIPATED)

July 1, 2018

Study Registration Dates

First Submitted

June 8, 2017

First Submitted That Met QC Criteria

June 27, 2017

First Posted (ACTUAL)

June 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2019

Last Update Submitted That Met QC Criteria

June 12, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-8009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data collected during the study will only be shared with researchers approved to key-personnel on the study protocol.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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