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Thrombin Generation in Neonatal Plasma After Cardiopulmonary Bypass

NCT01352143 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2013-11-20

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Children's Research Oversight Committee Funds

    collaborator UNKNOWN

  • Emory University

    lead OTHER

Principal Investigators

  • Nina A Guzzetta, M.D. · Emory University

Eligibility

Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01352143 on ClinicalTrials.gov