Trials / Withdrawn
WithdrawnNCT03202524
Fresh Frozen Plasma as a Substitute for Albumin in Patients Receiving a Large Volume Paracentesis
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Montefiore Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Fresh Frozen Plasma (FFP) | FFP will be used as a substitute for albumin for the prevention of post-paracentesis circulatory dysfunction. |
| BIOLOGICAL | Albumin | Albumin will be used for the prevention of post-paracentesis circulatory dysfunction, as is the standard of care |
Timeline
- Start date
- 2017-12-01
- Primary completion
- 2018-07-01
- Completion
- 2018-07-01
- First posted
- 2017-06-28
- Last updated
- 2019-06-14
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03202524. Inclusion in this directory is not an endorsement.