Trials / Completed
CompletedNCT02557672
PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding
Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for Post-cardiopulmonary Bypass Coagulopathy and Bleeding, a Prospective Randomized Trial at Large US Medical Center.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 106 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This will be the first prospective randomized controlled clinical trial directly comparing Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for post cardiopulmonary bypass microvascular bleeding and factor-mediated coagulopathy. Is there a difference in bleeding and transfusion requirements in patients received PCC versus FFP?
Conditions
- Bleeding
- Blood Loss, Surgical
- Cardiovascular Surgical Procedures
- Prothrombin Complex Concentrates
- Fresh Frozen Plasma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Prothrombin complex concentrate (Human) | PCC (Kcentra) |
| BIOLOGICAL | Fresh frozen plasma (FFP) | FFP |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2021-06-01
- Completion
- 2022-01-01
- First posted
- 2015-09-23
- Last updated
- 2022-06-07
- Results posted
- 2022-06-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02557672. Inclusion in this directory is not an endorsement.