Expired Study
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Rochester, Minnesota 55905


Purpose:

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?


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


NCT ID:

NCT02557672


Primary Contact:

Principal Investigator
Gregory Nuttall, MD
Mayo Clinic


Backup Contact:

N/A


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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