NCT01352143

Thrombin Generation in Neonatal Plasma After Cardiopulmonary Bypass

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 30 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiopulmonary Bypass

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-05-11
• Last updated: 2013-11-20

Locations

1 site across 1 country: United States