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

NCT04109144 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 2019-10354
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Large volume paracentesis (LVP) 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 determine if the administration of Fresh Frozen Plasma (FFP) during large volume paracentesis is effective in lowering plasma renin activity by 25% compared to baseline.

Conditions

Liver Cirrhosis; Ascites Hepatic

Keywords

Paracentesis; Albumin; Plasma

Outcome Measures

Primary Outcomes (1)

• Change in plasma renin activity (PRA) post paracentesis

  Efficacy of LVP with FFP will be measured as the change of plasma renin activity (PRA) from Day 1 to Day 6 during the 2nd LVP with FFP. We hypothesize that FFP will reduce the PRA by 25% from Day 1 to Day 6.

  6 Days

Secondary Outcomes (2)

• Occurrence of post-paracentesis circulatory dysfunction (PPCD)

  6 days

• Safety: Adverse Events (AE)

  6 days

Study Arms (2)

Large Volume Paracentesis (LVP) with Fresh Frozen Plasma (FFP)

EXPERIMENTAL

All participants who are scheduled for a LVP and meet the eligibility criteria will be monitored for 3 consecutive periods. At the second drainage participants will receive 2 units, or about 500 ccs, of fresh frozen plasma intravenously, plus 1 bottle, or 50 ccs, of 25% albumin if more than 4 liters of fluid are removed

Biological: Fresh Frozen Plasma (FFP); Procedure: Large Volume Paracentesis (LVP)

Large Volume Paracentesis (LVP) with Albumin

ACTIVE COMPARATOR

All participants who are scheduled for a LVP and meet the eligibility criteria will be monitored for 3 consecutive periods. At the first and third drainage participants will receive 1 bottle, or 50 ccs, of 25% albumin intravenously for every two liters of fluid removed

Biological: Albumin; Procedure: Large Volume Paracentesis (LVP)

Interventions

Fresh Frozen Plasma (FFP) BIOLOGICAL

FFP will be used as a substitute for albumin during the 2nd of 3 total paracentesis being monitored

Large Volume Paracentesis (LVP) with Fresh Frozen Plasma (FFP)

Albumin BIOLOGICAL

Albumin will be used during the 1st and 3rd paracentesis

Large Volume Paracentesis (LVP) with Albumin

Large Volume Paracentesis (LVP) PROCEDURE

All participants who have this procedure, meet eligibility criteria and who consent

Large Volume Paracentesis (LVP) with Albumin; Large Volume Paracentesis (LVP) with Fresh Frozen Plasma (FFP)

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
• INR \> 1.7, \<2.5

You may not qualify if:

• Inability to obtain informed consent
• Age less than 18
• Hepatic Encephalopathy Grade \> 1 as defined by the presence of an impaired mental status or the presence of asterixis
• 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 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single arm, single center, investigator initiated, prospective pilot clinical trial study.

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 30, 2019
• Study Start: November 11, 2019
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share