Trials / Terminated
TerminatedNCT02037373
Evaluation of the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation
Post-Marketing Requirement Study to Evaluate the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation With Special Emphasis on Hyperfibrinolysis.
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 43 (actual)
- Sponsor
- Octapharma · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Post-Marketing Requirement study to evaluate the safety of octaplas™ versus plasma in patients undergoing orthotopic liver transplantation (OLT). The primary objective is to assess the incidence of hyperfibrinolysis in patients undergoing (OLT) receiving octaplas™ versus regular plasma (e.g., fresh frozen plasma and other FDA and AABB approved plasma products).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Octaplas™ | Octaplas™ infusion solution for IV administration as prescribed by the treating physician. |
| BIOLOGICAL | Plasma | Plasma as prescribed by the treating physician. |
Timeline
- Start date
- 2015-08-01
- Primary completion
- 2018-02-01
- Completion
- 2018-02-01
- First posted
- 2014-01-15
- Last updated
- 2018-03-07
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02037373. Inclusion in this directory is not an endorsement.