Clinical trial NCT02557672: PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bleeding
Blood Loss, Surgical
Cardiovascular Surgical Procedures
Prothrombin Complex Concentrates
Fresh Frozen Plasma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: CSL Behring
First posted: 2015-09-23
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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?


Eligibility 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

Primary outcomes:
measure: Chest Tube Output
timeFrame: 24 hours
measure: Red Blood Cell (RBC) Blood Product Transfusion
timeFrame: 24 hours
measure: Platelets Blood Product Transfusion
timeFrame: 24 hours
measure: Cryoprecipitate (Cryo) Blood Product Transfusion
timeFrame: 24 hours
measure: Fresh Frozen Plasma (FFP) Blood Product Transfusion
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Gregory Nuttall, MD
role: PRINCIPAL_INVESTIGATOR
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