A Study Using Prothrombin Complex Concentrate versus Fresh Frozen Plasma for Post Cardiopulmonary Bypass Surgery Clotting Problems and Bleeding

Overview

About this study

The purpose of this study is to directly compare prothrombin complex concentrate to fresh frozen plasma for microvascular bleeding and factor-mediated clotting disorder post cardiopulmonary bypass surgery.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Be ≥ 18 years of age.
Be undergoing a cardiac surgical procedure utilizing cardiopulmonary bypass.
Have an INR ≤ 1.3 if warfarin was not held for 5 days.

Exclusion Criteria:

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 with past 3 months.
Received oral therapy with ELIQUIS (apixaban) within 3 days prior to planned surgical procedure.
Received oral therapy with clopidogrel,prasugrel, rivaroxaban or dabigatran within 5 days prior to planned surgical procedure.
Are undergoing emergency open heart-surgery.
Cardiopulmonary bypass time is expected to be < 30 minutes.
Are pregnant.
Heparin allergy.
ECMO post op.
Life threatening bleeding necessitating transfusion of hemostatic products (FFP or PCC) prior to the study intervention time point.
Circumstances for which the safety of the patient could be jeopardized by continued adherence to the study protocol.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Gregory Nuttall, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Gregory Nuttall, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

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