Thrombin Generation in Neonatal Plasma After Cardiopulmonary Bypass

This study has been completed.
Sponsor:
Collaborator:
Children's Research Oversight Committee Funds
Information provided by (Responsible Party):
Nina Guzzetta, M.D., Emory University
ClinicalTrials.gov Identifier:
NCT01352143
First received: April 20, 2011
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Cardiopulmonary Bypass
Drug: Recombinant activated factor VII
Drug: Prothrombin Complex Concentrate

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Measurements of Thrombin Generation in Response to Recombinant Activated Factor VII and Prothrombin Complex Concentrate in Neonatal Plasma After Cardiopulmonary Bypass

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Peak thrombin Generation [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Blood samples only


Enrollment: 24
Study Start Date: March 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
    Other Name: NovoSeven RT, Novo Nordisk, Bagsvaerd, Denmark
    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
    Other Name: Beriplex P/N, CSL Behring, King of Prussia, PA
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.

  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352143

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Children's Research Oversight Committee Funds
Investigators
Principal Investigator: Nina A Guzzetta, M.D. Emory University
  More Information

No publications provided

Responsible Party: Nina Guzzetta, M.D., Associate Professor of Anesthesiology, Emory University
ClinicalTrials.gov Identifier: NCT01352143     History of Changes
Other Study ID Numbers: IRB00048151
Study First Received: April 20, 2011
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Neonates

Additional relevant MeSH terms:
Thrombin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014