Thrombin Generation in Neonatal Plasma After Cardiopulmonary Bypass

Cardiopulmonary Bypass Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01352143
• Other study ID #: IRB00048151
• Status: Completed
• Phase: N/A
• First received: April 20, 2011
• Last updated: November 19, 2013
• Start date: March 2011
• Est. completion date: June 2012

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Days

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiopulmonary Bypass

Intervention

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
• Prothrombin Complex Concentrate
Plasma will be spiked in vitro with prothrombin complex concentrate to determine increases in thrombin generation with and without the drug

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Children's Research Oversight Committee Funds

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No