Heparin Management During Cardiopulmonary Bypass in Children

Completed

Conditions studied: Primary Condition: Heart Defects Requiring Surgery With CPB

In brief

We propose a comparison between between our standard ACT based heparin management protocol for children undergoing CPB and a patient-specific heparin concentration-based heparin management protocol. We hypothesize that a heparin concentration-based anticoagulation management protocol during CPB in children will result in more effective attenuation of hemostatic activation as reflected by decreased levels of thrombin formation and, ultimately, better preservation of hemostasis postoperatively. An additional 20 patients will be enrolled to address the validation of heparin concentrations calculated by the Hepcon machine with laboratory-measured heparin concentrations. These patients will not be randomized and therefore will not receive an intervention.

Key facts

Study ID

NCT00146653

Run by

Emory University

People needed

20

Starts

2005-12-01

Expected to finish

2010-01-01

Last updated by the study team

2013-11-20

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing elective cardiac surgical procedures requiring CPB at Children's Healthcare of Atlanta at Egleston.
• Patients less than 6 months old.
• Parent/legal guardian willing to sign consent. -

You may not qualify if…

• Patients presenting for emergency surgery.
• Patients treated preoperatively with anticoagulant therapy.
• Patients treated with antifibrinolytics during their cardiac surgery.
• Parent/legal guardian unwilling or unable to sign consent. -

Where it is running

• Children's Healthcare of Atlanta at Egleston — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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