Liver CirrhosisPhase 2NCT04109144
Fresh Frozen Plasma as a Substitute for Albumin in Patients Receiving a Large Volume Paracentesis
A Phase 2 study testing Fresh Frozen Plasma (FFP), Albumin and Large Volume Paracentesis (LVP) in people with Liver Cirrhosis and Ascites Hepatic, run by Montefiore Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Ascites Hepatic
- What is being tested?
- Fresh Frozen Plasma (FFP), Albumin and Large Volume Paracentesis (LVP)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 Nov 2019to Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
About this study
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.
Read the 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:
- 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
- nd Period: Day 1: pre-LVP baseline labs and measurements, LVP with FFP administration Day 6: Laboratory testing and measurements
- 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
- Being tested
- Fresh Frozen Plasma (FFP), Albumin, Large Volume Paracentesis (LVP)
- Keywords
- Paracentesis, Albumin, Plasma
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh Frozen Plasma (FFP)Biological
FFP will be used as a substitute for albumin during the 2nd of 3 total paracentesis being monitored
AlbuminBiological
Albumin will be used during the 1st and 3rd paracentesis
Large Volume Paracentesis (LVP)Procedure or surgery
All participants who have this procedure, meet eligibility criteria and who consent
| Study group | Role | What they receive |
|---|---|---|
| Large Volume Paracentesis (LVP) with Fresh Frozen Plasma (FFP) | Experimental | 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 Receives: Biological: Fresh Frozen Plasma (FFP); Procedure: Large Volume Paracentesis (LVP) |
| Large Volume Paracentesis (LVP) with Albumin | Active comparator | 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 Receives: Biological: Albumin; Procedure: Large Volume Paracentesis (LVP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma renin activity (PRA) post paracentesis
Efficacy of LVP with FFP will be measured as the change of plasma renin activity (PRA) from Day 1 to Day 6 during the 2nd LVP with FFP. We hypothesize that FFP will reduce the PRA by 25% from Day 1 to Day 6.
Measured: 6 Days
Secondary outcomes (2)
Occurrence of post-paracentesis circulatory dysfunction (PPCD)
We hypothesize that the PPCD incidence will reduce in the 2nd LVP with FFP in comparison to the 1st LVP with albumin.
Measured: 6 days
Safety: Adverse Events (AE)
We hypothesize that the overall adverse events (including PPCD incidence) will be reduced in the 2nd LVP with FFP in comparison to the 1st LVP with albumin. AE's will be summarized by presenting the number and percentages of patients having any AE.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start11 Nov 2019
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Why it stopped: PI confirmed that while coordination and planning was conducted upon IRB approval, no participants were enrolled into the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- single arm, single center, investigator initiated, prospective pilot clinical trial study.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Sigal, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109144
- Sponsor's protocol ID
- 2019-10354
- Other IDs
- 2019
- Status last verified
- Aug 2022
- First submitted
- 25 Sep 2019
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data collected during the study will only be shared with researchers that have been IRB approved as key-personnel on the study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fresh Frozen Plasma as a Substitute for Albumin in Patients Receiving a Large Volume Paracentesis
- ClinicalTrials.gov ID
- NCT04109144
- Acronym / sponsor ID
- 2019-10354
- Conditions
- Liver Cirrhosis, Ascites Hepatic
- Keywords
- Paracentesis, Albumin, Plasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI confirmed that while coordination and planning was conducted upon IRB approval, no participants were enrolled into the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- nd Period: Day 1: pre-LVP baseline labs and measurements, LVP with FFP administration Day 6: Laboratory testing and measurements
- rd Period: Day 1: pre-LVP baseline labs and measurements, LVP with albumin administration Day 6: Laboratory testing and measurements
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- single arm, single center, investigator initiated, prospective pilot clinical trial study.
| Arm | Type | Receives |
|---|---|---|
| Large Volume Paracentesis (LVP) with Fresh Frozen Plasma (FFP) | Experimental | Biological: Fresh Frozen Plasma (FFP), Procedure: Large Volume Paracentesis (LVP)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 |
| Large Volume Paracentesis (LVP) with Albumin | Active comparator | Biological: Albumin, Procedure: Large Volume Paracentesis (LVP)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresh Frozen Plasma (FFP)FFP will be used as a substitute for albumin during the 2nd of 3 total paracentesis being monitored | Biological | Large Volume Paracentesis (LVP) with Fresh Frozen Plasma (FFP) |
| AlbuminAlbumin will be used during the 1st and 3rd paracentesis | Biological | Large Volume Paracentesis (LVP) with Albumin |
| Large Volume Paracentesis (LVP)All participants who have this procedure, meet eligibility criteria and who consent | Procedure or surgery | Large Volume Paracentesis (LVP) with Albumin, Large Volume Paracentesis (LVP) with Fresh Frozen Plasma (FFP) |
Primary outcome
Change in plasma renin activity (PRA) post paracentesis
Time frame: 6 Days
Efficacy of LVP with FFP will be measured as the change of plasma renin activity (PRA) from Day 1 to Day 6 during the 2nd LVP with FFP. We hypothesize that FFP will reduce the PRA by 25% from Day 1 to Day 6.
2 secondary outcomes
Occurrence of post-paracentesis circulatory dysfunction (PPCD)
Time frame: 6 days
Safety: Adverse Events (AE)
Time frame: 6 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: No. Data collected during the study will only be shared with researchers that have been IRB approved as key-personnel on the study protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Sigal, MD principal investigator
Montefiore Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fresh Frozen Plasma (FFP), Albumin and Large Volume Paracentesis (LVP) in people with Liver Cirrhosis and Ascites Hepatic, run by Montefiore Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma renin activity (PRA) post paracentesis (time frame: 6 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.