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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03202524
• Other study ID #: 2017-8009
• Status: Withdrawn
• Phase: Phase 4
• Start date: December 2017
• Est. completion date: July 2018

Study information

• Verified date: June 2019
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ascites
• Ascites Hepatic
• Liver Cirrhosis

Intervention

Biological:
• Fresh Frozen Plasma (FFP)
FFP will be used as a substitute for albumin for the prevention of post-paracentesis circulatory dysfunction.
• Albumin
Albumin will be used for the prevention of post-paracentesis circulatory dysfunction, as is the standard of care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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