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

NCT03202524 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2017-8009
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Cirrhosis; Ascites Hepatic

Keywords

Paracentesis; Albumin; Plasma

Outcome Measures

Primary Outcomes (1)

• Incidence of Post-Paracentesis Circulatory Dysfunction (PPCD)

  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

Study Arms (2)

Albumin

ACTIVE COMPARATOR

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

Biological: Albumin

Fresh Frozen Plasma

EXPERIMENTAL

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)

Interventions

Fresh Frozen Plasma (FFP) BIOLOGICAL

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

Fresh Frozen Plasma

Albumin BIOLOGICAL

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

Albumin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inability to obtain informed consent
• Age less than 18
• Hepatic Encephalopathy Grade \> 1
• Septic shock
• Active infection
• Respiratory failure
• Heart failure with reduced ejection fraction of ≤ 50%
• Moderate or severe pulmonary hypertension
• History of stroke
• Unstable coronary artery disease
• Chronic kidney disease (GFR \<60)
• GI bleed within 2 weeks
• Any licorice within 2 weeks of starting the study
• Any Beta Blocker use within the last 2 weeks
• Any diuretic use within 2 weeks

Sponsors & Collaborators

• Montefiore Medical Center: lead

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Albumins

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Samuel Sigal, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 28, 2017
• Study Start: December 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: June 14, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share