NCT00146653|Completed
Heparin Management During Cardiopulmonary Bypass in Children
A Comparison of Heparin Management Strategies in Children Undergoing Cardiopulmonary Bypass.
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A Comparison of Heparin Management Strategies in Children Undergoing Cardiopulmonary Bypass.
Sponsor study identifier
observational
20
1 country
1
Study Start
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2010
Actual (reported)Study Completion
January 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2010
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2, 2005
Actual (reported)September 7, 2005
Actual (reported)December 2005
Date type not reportedThis date has not been verified as actual or estimated.
January 2010
Actual (reported)January 2010
Actual (reported)Xa sample is being collected to validate the results from the Hepcon Assay. The Hepcon results are being compared to the Hemochron and iStat ACT results.
The Xa sample is being collected before the initiation of cardiopulmonary bypass and immediately prior to the discontinuation of cardiopulmonary bypass.
Transfusion requirements and patient bleeding postoperatively.
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. .
Patients will be obtained from the patient's of Children's Healthcare of Atlanta at Egleston. These patients will be obtained from the pre-operative clinc, the Cardiac Intensive Care Unit or the Cardiac Stepdown unit.
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322, United States
Culliford AT, Gitel SN, Starr N, Thomas ST, Baumann FG, Wessler S, Spencer FC. Lack of correlation between activated clotting time and plasma heparin during cardiopulmonary bypass. Ann Surg. 1981 Jan;193(1):105-11. doi: 10.1097/00000658-198101000-00017.
Horkay F, Martin P, Rajah SM, Walker DR. Response to heparinization in adults and children undergoing cardiac operations. Ann Thorac Surg. 1992 May;53(5):822-6. doi: 10.1016/0003-4975(92)91444-e.
Blood is being collected to obtain Xa results.
Nina A Guzzetta, MD
Emory University
20 participants (actual enrollment reported by the registry).
First Submitted
September 2, 2005
First Posted
September 7, 2005
Study Start
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
January 2010
Actual (reported)Study Completion
January 2010
Actual (reported)Last Updated
November 20, 2013
Record last verified: 2013-11
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