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

Primary Purpose

Liver Cirrhosis, Ascites Hepatic

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Fresh Frozen Plasma (FFP)

Albumin

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Paracentesis, Albumin, Plasma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Inability to obtain informed consent
Age less than 18
Hepatic Encephalopathy Grade > 1
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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Albumin

Fresh Frozen Plasma

Arm Description

Patients undergoing large volume paracentesis with receive 50ml of 25% albumin for every 2 L removed from their abdomen.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03202524

First Posted

June 8, 2017

Last Updated

June 12, 2019

Sponsor

Montefiore Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03202524

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Study was never approved by the IRB

Study Start Date

December 2017 (Anticipated)

Primary Completion Date

July 2018 (Anticipated)

Study Completion Date

July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cirrhosis, Ascites Hepatic

Keywords

Paracentesis, Albumin, Plasma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Randomized Control Trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Albumin

Arm Type

Active Comparator

Arm Description

Patients undergoing large volume paracentesis with receive 50ml of 25% albumin for every 2 L removed from their abdomen.

Arm Title

Fresh Frozen Plasma

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Fresh Frozen Plasma (FFP)

Intervention Description

FFP will be used as a substitute for albumin for the prevention of post-paracentesis circulatory dysfunction.

Intervention Type

Biological

Intervention Name(s)

Albumin

Intervention Description

Albumin will be used for the prevention of post-paracentesis circulatory dysfunction, as is the standard of care

Primary Outcome Measure Information:

Title

Incidence of Post-Paracentesis Circulatory Dysfunction (PPCD)

Description

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

Time Frame

6 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: Inability to obtain informed consent Age less than 18 Hepatic Encephalopathy Grade > 1 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samuel Sigal, MD

Organizational Affiliation

Montefiore Medical Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data collected during the study will only be shared with researchers approved to key-personnel on the study protocol.

Learn more about this trial

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

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