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

NCT ID: NCT04109144

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-11
• Study Completion Date: 2023-07-31

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.

Detailed Description

There will be three periods of this study, one for each of three consecutive routine large volume paracenteses. The length of the study will be 6 days post paracentesis for each period, for a total of 3 periods. The interval between successive LVP's will be determined by patients' need. In order to ensure follow up on Day 6, Day 1 will be restricted to a Tuesday, Wednesday, Thursday, or Friday.

All participants will be monitored for 3 consecutive routine large volume paracenteses. The 3 periods (LVP's) of this study will differ in administration of volume replacement solution. First LVP will be with intravenous albumin (12.5gm 25% Human Albumin for every 2 liters removed), 2nd LVP with administration 1 unit of FFP for every 2 liters removed for the first 4 liters followed by 12.5gm 25% albumin for every subsequent 2 liters removed, and 3rd LVP again with administration of intravenous albumin. The first LVP serves as the study entry time period and also as a control period for the same patient. The second LVP is to test the new intervention with FFP. The third LVP is included so that we can monitor the patient's status.

Albumin or FFP administration:

Albumin administration:

50ml of 25% albumin for every 2L removed

FFP administration:

2 units of FFP for the first 4L removed followed by 50ml of 25% albumin for every additional 2L removed FFP will be supplied by the Blood Bank and albumin from the pharmacy at Montefiore Medical Center.

Details for each study period:

1. st Period: Day 1: Enrollment, baseline pre-LVP laboratory testing and measurements, and large volume paracentesis with administration of albumin Day 6: Laboratory testing and measurements

2. nd Period: Day 1: pre-LVP baseline labs and measurements, LVP with FFP administration Day 6: Laboratory testing and measurements

3. rd Period: Day 1: pre-LVP baseline labs and measurements, LVP with albumin administration Day 6: Laboratory testing and measurements

Conditions

Liver Cirrhosis; Ascites Hepatic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Fresh Frozen Plasma (FFP)

Intervention Type: BIOLOGICAL

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

Large Volume Paracentesis (LVP)

Intervention Type: PROCEDURE

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

Large Volume Paracentesis (LVP) with Albumin

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

Group Type: ACTIVE_COMPARATOR

Albumin

Intervention Type: BIOLOGICAL

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

Large Volume Paracentesis (LVP)

Intervention Type: PROCEDURE

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

Interventions

Fresh Frozen Plasma (FFP)

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

Intervention Type: BIOLOGICAL

Albumin

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

Intervention Type: BIOLOGICAL

Large Volume Paracentesis (LVP)

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

7. INR > 1.7, <2.5

Exclusion Criteria

1. Inability to obtain informed consent

2. Age less than 18

3. Hepatic Encephalopathy Grade > 1 as defined by the presence of an impaired mental status or the presence of asterixis

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

19. Pregnancy - pregnancy test will be administered for all female patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel Sigal, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Other Identifiers

2019-10354

Identifier Type: -

Identifier Source: org_study_id