Status:
WITHDRAWN
Fresh Frozen Plasma as a Substitute for Albumin in Patients Receiving a Large Volume Paracentesis
Lead Sponsor:
Montefiore Medical Center
Conditions:
Liver Cirrhosis
Ascites Hepatic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Absence of paracentesis within 2 weeks
- Absence of volume expanders within 2 weeks
- INR \> 1.7
- Pregnancy - pregnancy test will be administered for all female patients
Key Trial Info
Start Date :
November 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04109144
Start Date
November 11 2019
End Date
July 1 2023
Last Update
August 25 2022
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.