Thrombin Generation in Neonatal Plasma After Cardiopulmonary Bypass

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Cardiopulmonary Bypass

Clinical Trial Details

NCT number	NCT01352143
Study type	Observational
Source	Emory University
Contact
Status	Completed
Phase	N/A
Start date	March 2011
Completion date	June 2012

View Details

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