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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-31

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Liver Cirrhosis Ascites Hepatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Control Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Albumin

Patients undergoing large volume paracentesis with receive 50ml of 25% albumin for every 2 L removed from their abdomen.

Group Type ACTIVE_COMPARATOR

Albumin

Intervention Type BIOLOGICAL

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

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

Group Type EXPERIMENTAL

Fresh Frozen Plasma (FFP)

Intervention Type BIOLOGICAL

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

Interventions

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Fresh Frozen Plasma (FFP)

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

Intervention Type BIOLOGICAL

Albumin

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No