Expired Study
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Rochester, Minnesota 55905


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?


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



Primary Contact:

Principal Investigator
Gregory Nuttall, MD
Mayo Clinic

Backup Contact:


Location Contact:

Rochester, Minnesota 55905
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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