Liver CirrhosisPhase 4NCT03202524
Fresh Frozen Plasma as a Substitute for Albumin in Patients Receiving a Large Volume Paracentesis
A Phase 4 study testing Fresh Frozen Plasma (FFP) and Albumin in people with Liver Cirrhosis and Ascites Hepatic, run by Montefiore Medical Center.
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. 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) and Albumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2017to Jul 2018
- Phase
- Phase 4
- 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
Who cannot join
- Inability to obtain informed consent
- Age less than 18
- Hepatic Encephalopathy Grade > 1
- Septic shock
- Active infection
- Respiratory failure
Show all 18Show 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
About this study
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.
- Conditions
- Liver Cirrhosis, Ascites Hepatic
- Being tested
- Fresh Frozen Plasma (FFP), Albumin
- 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 for the prevention of post-paracentesis circulatory dysfunction.
AlbuminBiological
Albumin will be used for the prevention of post-paracentesis circulatory dysfunction, as is the standard of care
| Study group | Role | What they receive |
|---|---|---|
| Albumin | Active comparator | Patients undergoing large volume paracentesis with receive 50ml of 25% albumin for every 2 L removed from their abdomen. Receives: Biological: Albumin |
| Fresh Frozen Plasma | Experimental | 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 Receives: Biological: Fresh Frozen Plasma (FFP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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 posted28 Jun 2017
- Study startDec 2017 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Why it stopped: Study was never approved by the IRB
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- 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
- NCT03202524
- Sponsor's protocol ID
- 2017-8009
- Status last verified
- Jun 2019
- First submitted
- 8 Jun 2017
- Last updated
- 14 Jun 2019
- 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 approved to key-personnel on the study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. 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
- NCT03202524
- Acronym / sponsor ID
- 2017-8009
- Conditions
- Liver Cirrhosis, Ascites Hepatic
- Keywords
- Paracentesis, Albumin, Plasma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never approved by the IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 28 Jun 2017 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Albumin | Active comparator | Biological: AlbuminPatients undergoing large volume paracentesis with receive 50ml of 25% albumin for every 2 L removed from their abdomen. |
| Fresh Frozen Plasma | Experimental | Biological: Fresh Frozen Plasma (FFP)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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 (18 listed)
- Inability to obtain informed consent
- Age less than 18
- Hepatic Encephalopathy Grade > 1
- 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 for the prevention of post-paracentesis circulatory dysfunction. | Biological | Fresh Frozen Plasma |
| AlbuminAlbumin will be used for the prevention of post-paracentesis circulatory dysfunction, as is the standard of care | Biological | Albumin |
Primary outcome
Incidence of Post-Paracentesis Circulatory Dysfunction (PPCD)
Time frame: 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
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 14 Jun 2019.
- Individual participant dataSharing planned: No. Data collected during the study will only be shared with researchers approved to 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 4 study testing Fresh Frozen Plasma (FFP) and Albumin 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 6 inclusion and 18 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 14 Jun 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Incidence of Post-Paracentesis Circulatory Dysfunction (PPCD) (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 14 Jun 2019.