Thrombin Generation in Neonatal Plasma After Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
The primary goal of this investigation is to determine the ability of recombinant activated factor VII (rFVIIa) and prothrombin complex concentrate (PCC) to improve thrombin generation in neonatal plasma after CPB.

Detailed Description
-----------------
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.

Official Title
-----------------
Measurements of Thrombin Generation in Response to Recombinant Activated Factor VII and Prothrombin Complex Concentrate in Neonatal Plasma After Cardiopulmonary Bypass

Conditions
-----------------
Cardiopulmonary Bypass

Intervention / Treatment
-----------------
* Drug: Recombinant activated factor VII
* Drug: Prothrombin Complex Concentrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Full-term neonates (36-42 weeks gestational age) Apgar score of 7 or more at 5 minutes after delivery Neonates undergoing elective cardiac surgery requiring CPB at Children's Healthcare of Atlanta at Egleston Parents willing to participate, and able to understand and sign the provided informed consent Exclusion criteria: Preterm neonates (less than 36 weeks gestation) Apgar score of less than 6 at 5 minutes after birth Emergent procedure Patients undergoing cardiac surgery not requiring CPB Neonates with a known coagulation defect or coagulopathy Mother with a known coagulation defect or coagulopathy Parents unwilling to participate or unable to understand and sign the provided informed consent

Ages Eligible for Study
-----------------
Maximum Age: 30 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|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|
|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|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak thrombin Generation | 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. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neonates