PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding

• Status: Enrolling by invitation
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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?

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: CSL Behring
• Treatments: Thrombin

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