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

Phase 4

Withdrawn

• Conditions: Ascites Hepatic; Liver Cirrhosis
• Interventions: Biological: Fresh Frozen Plasma (FFP); Biological: Albumin

• Registration Number: NCT03202524
• Lead Sponsor: Montefiore Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-06-28
• Study Start: 2017-12
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-12
• Last Update Posted: 2019-06-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fresh Frozen Plasma	Fresh Frozen Plasma (FFP)	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
Albumin	Albumin	Patients undergoing large volume paracentesis with receive 50ml of 25% albumin for every 2 L removed from their abdomen.

Primary Outcome Measures

Name	Time	Method
Incidence of Post-Paracentesis Circulatory Dysfunction (PPCD)	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