An observational study in Cardiopulmonary Bypass, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged Up to 30 Days. Per ClinicalTrials.gov, last updated 2013-11-20.
Sponsored by Emory University · Observational
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.
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.
Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Neonates (less than 30 days of age) undergoing complex congenital cardiac surgery requiring cardiopulmonary bypass
Exclusion criteria:
Plasma will be spiked in vitro with recombinant activated factor VII to assess increases in thrombin generation with and without the drug
Also known as: NovoSeven RT, Novo Nordisk, Bagsvaerd, Denmark
Plasma will be spiked in vitro with prothrombin complex concentrate to determine increases in thrombin generation with and without the drug
Also known as: Beriplex P/N, CSL Behring, King of Prussia, PA
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.
Time frame: one year
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Emory University