PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding



Status:Enrolling by invitation
Conditions:Hospital, Hematology
Therapuetic Areas:Hematology, Other
Healthy:No
Age Range:18 - Any
Updated:8/26/2018
Start Date:August 2016
End Date:December 2019

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Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for Post-cardiopulmonary Bypass Coagulopathy and Bleeding, a Prospective Randomized Trial at Large US Medical Center.

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
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1
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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