Thrombin Generation in Neonatal Plasma After Cardiopulmonary Bypass

NCT01352143 | Completed DMC

• 1 other identifier: IRB00048151
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiopulmonary Bypass

Keywords

Neonates

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Recombinant activated factor VII DRUG

Plasma will be spiked in vitro with recombinant activated factor VII to assess increases in thrombin generation with and without the drug

Also known as: NovoSeven RT, Novo Nordisk, Bagsvaerd, Denmark

Prothrombin Complex Concentrate DRUG

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

Also known as: Beriplex P/N, CSL Behring, King of Prussia, PA

Eligibility Criteria

• Age: Up to 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead
• Children's Research Oversight Committee Funds: collaborator

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples only

MeSH Terms

Interventions

Factor IX; factor IX, factor VII, factor X, prothrombin drug combination

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Officials

• Nina A Guzzetta, M.D.

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: May 11, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 20, 2013

Record last verified: 2013-11

Locations

US (1)