Thrombin Generation in Neonatal Plasma After Cardiopulmonary Bypass

Completed

• Conditions: Cardiopulmonary Bypass

• Registration Number: NCT01352143
• Lead Sponsor: Emory University

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-05-10
• Study First Posted: 2011-05-11
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-19
• Last Update Posted: 2013-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Full-term neonates (36-42 weeks gestational age)
2. Apgar score of 7 or more at 5 minutes after delivery
3. Neonates undergoing elective cardiac surgery requiring CPB at Children's Healthcare of Atlanta at Egleston
4. Parents willing to participate, and able to understand and sign the provided informed consent

Exclusion criteria:

1. Preterm neonates (less than 36 weeks gestation)
2. Apgar score of less than 6 at 5 minutes after birth
3. Emergent procedure
4. Patients undergoing cardiac surgery not requiring CPB
5. Neonates with a known coagulation defect or coagulopathy
6. Mother with a known coagulation defect or coagulopathy
7. Parents unwilling to participate or unable to understand and sign the provided informed consent

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak thrombin Generation	one year	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.

Trial Locations

Locations (1)

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States