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

Montefiore Medicine Academic Health System

Status and phase: Withdrawn; Phase 4

Conditions: Liver Cirrhosis; Ascites Hepatic

Treatments: Biological: Albumin; Biological: Fresh Frozen Plasma (FFP)

Study type: Interventional

Funder types: Other

Identifiers

NCT03202524

2017-8009

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Albumin

Active Comparator group

Description:

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

Treatment:

Biological: Albumin

Fresh Frozen Plasma

Experimental group

Description:

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

Treatment:

Biological: Fresh Frozen Plasma (FFP)