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

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.

Study Overview

• Status: Completed
• Conditions: Cardiopulmonary Bypass
• Intervention / Treatment: Drug: Recombinant activated factor VII; Drug: Prothrombin Complex Concentrate

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 Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Neonates (less than 30 days of age) undergoing complex congenital cardiac surgery requiring cardiopulmonary bypass

Description

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

Study Plan

How is the study designed?

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

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Children's Research Oversight Committee Funds
• Investigators: Principal Investigator: Nina A Guzzetta, M.D., Emory University

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: April 20, 2011
• First Submitted That Met QC Criteria: May 10, 2011
• First Posted (Estimate): May 11, 2011

Study Record Updates

• Last Update Posted (Estimate): November 20, 2013
• Last Update Submitted That Met QC Criteria: November 19, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Neonates
• Additional Relevant MeSH Terms: Hemostatics; Coagulants; Thrombin
• Other Study ID Numbers: IRB00048151