Thrombin Generation in Neonatal Plasma After Cardiopulmonary Bypass

• Peak thrombin Generation [ Time Frame: one year ] [ Designated as safety issue: No ]
  The primary outcome measure is the peak amount of thrombin generated (measured in nM) as determined by the Thrombinoscope with rFVIIa as compared to PCC.
  
  

Drug: Recombinant activated factor VII
Plasma will be spiked in vitro with recombinant activated factor VII to assess increases in thrombin generation with and without the drug
Other Name: NovoSeven RT, Novo Nordisk, Bagsvaerd, Denmark
Drug: Prothrombin Complex Concentrate
Plasma will be spiked in vitro with prothrombin complex concentrate to determine increases in thrombin generation with and without the drug
Other Name: Beriplex P/N, CSL Behring, King of Prussia, PA

In this investigation, the investigators propose a comparison in vitro of the ability of rFVIIa with that of PCC to increase thrombin generation in neonatal plasma after CPB. A pre-cardiopulmonary bypass (CPB) baseline blood sample will be obtained. After the termination of CPB and the administration of one round of protamine, platelets and fibrinogen (standard of care), a second blood sample will be drawn. All samples will be centrifuged to yield platelet rich plasma and stored until processing. In the pre-CPB sample, baseline thrombin generation will be measured. The post-CPB sample will be divided into three aliquots to measure thrombin generation under three different circumstances: the first will serve as a control, the second will include rFVIIa and the third PCC.