Thrombin Generation in Neonatal Plasma After Cardiopulmonary Bypass

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-06-30

Brief Summary

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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

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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

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Cardiopulmonary Bypass

Keywords

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Neonates

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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NovoSeven RT, Novo Nordisk, Bagsvaerd, Denmark Beriplex P/N, CSL Behring, King of Prussia, PA

Eligibility Criteria

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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

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Nina Guzzetta, M.D.

Associate Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nina A Guzzetta, M.D.

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00048151

Identifier Type: -

Identifier Source: org_study_id