Phase 4
N=106
PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding
Bleeding · Blood Loss, Surgical · Cardiovascular Surgical Procedures · Prothrombin Complex Concentrates · Fresh Frozen Plasma
Bottom Line
View on ClinicalTrials.gov: NCT02557672 ↗Enrolled (actual)
106
Serious AEs
89.0%
Results posted
Jun 2022
Primary outcome: Primary: Chest Tube Output — 1022; 937 mL — p=0.84
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Prothrombin complex concentrate (Human) (Drug); Fresh frozen plasma (FFP) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chest Tube Output |
1022; 937 | 0.84 |
| PRIMARY Red Blood Cell (RBC) Blood Product Transfusion |
26; 36; 11; 8; 6; 5 | 0.09 |
| PRIMARY Platelets Blood Product Transfusion |
30; 36; 13; 9; 3; 3 | 0.51 |
| PRIMARY Cryoprecipitate (Cryo) Blood Product Transfusion |
40; 40; 2; 2; 5; 8 | 0.53 |
| PRIMARY Fresh Frozen Plasma (FFP) Blood Product Transfusion |
43; 48; 0; 1; 4; 2 | 0.39 |
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?
Eligibility Criteria
Inclusion Criteria
All subjects accepted for this study must:
- Be 18 years of age
- Be undergoing elective cardiac surgical procedure utilizing cardiopulmonary bypass
- Have evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team in addition to a PT >16.6 sec or INR >1.6 sec.
Exclusion Criteria
Subjects who have one or more of the following will be excluded from the study:
- Are unable to grant informed consent or comply with study procedure
- History of hypercoagulable condition (e.g. Factor V Leiden, AT-3 deficiency, Prothrombin gene mutation, Anti-phospholipid antibody syndrome, etc) or previous unprovoked thromboembolic complications
- Coagulopathic conditions such as factor deficiencies, factor inhibitors, heparin induced thrombocytopenia, or use of intravenous anticoagulants other than heparin at the time of cardiovascular surgery
- Thromboembolic event within past 3 months
- Received oral therapy with clopidogrel, prasugrel, rivaroxaban or dabigatran within the past 5 days
- Patients taking chronic warfarin therapy who have not discontinued treatment and demonstrated an INR <1.3 prior to surgery
- Fibrinogen level <150 mg/dL on initial post cardiopulmonary bypass labs
- Antithrombin 3 level < 80% control (preoperative)
- Are undergoing emergency open heart-surgery
- Cardiopulmonary bypass time is expected to be < 30 minutes
- Age < 18 years of age
- Are pregnant
Data sourced from ClinicalTrials.gov (NCT02557672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.