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

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03202524
• Collaborator: (none)
• Enrollment: 0
• Arms: 2
• Anticipated Duration (Months): 7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhosis; Ascites Hepatic	Biological: Fresh Frozen Plasma (FFP); Biological: Albumin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized Control TrialRandomized Control Trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Fresh Frozen Plasma as a Substitute for Albumin in Patients Receiving a Large Volume Paracentesis
• Anticipated Study Start Date: Dec 1, 2017
• Anticipated Primary Completion Date: Jul 1, 2018
• Anticipated Study Completion Date: Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Albumin Patients undergoing large volume paracentesis with receive 50ml of 25% albumin for every 2 L removed from their abdomen.	Biological: Albumin; Albumin will be used for the prevention of post-paracentesis circulatory dysfunction, as is the standard of care
Experimental: Fresh Frozen Plasma 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); FFP will be used as a substitute for albumin for the prevention of post-paracentesis circulatory dysfunction.

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Montefiore Medical Center

Investigators

• Principal Investigator: Samuel Sigal, MD, Montefiore Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT03202524
• Other Study ID Numbers: 2017-8009
• First Posted: Jun 28, 2017
• Last Update Posted: Jun 14, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Montefiore Medical Center: Paracentesis; Albumin; Plasma
• Additional relevant MeSH terms: Liver Cirrhosis; Ascites

Study Results

No Results Posted as of Jun 14, 2019