NCT00166140|Completed
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Sponsor study identifier
observational
125
1 country
1
Study Start
December 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2006
Actual (reported)Study Completion
May 2006
Actual (reported)Heparin is an anticoagulant or "blood thinner". Heparin is always given to patients undergoing open-heart surgery to prevent blood from clotting when a patient is placed on the heart-lung machine. Heparin works by combining with a protein in blood to prevent other proteins from working together to form a clot. The protein that heparin combines with seems to be different in infants and young children compared to adults. The purpose of this study is to determine which proteins in children have a direct impact on the way heparin works. We also want to see how this may change at different ages. We will enroll two age groups of children; birth to 2 years and 10 years or older. A total of 125 patients will be enrolled into this study. These patients will already be scheduled for open-heart surgery using a heart-lung machine. The testing involves taking blood samples when the patient is asleep for surgery; and later from their intravenous line, IV. They will all have IV's in place already because of the surgery. Therefore the study will cause no pain or discomfort for the patients who take part.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2006
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.
December 2002
Date type not reportedThis date has not been verified as actual or estimated.
September 12, 2005
Actual (reported)September 14, 2005
Actual (reported)May 2006
Actual (reported)May 2006
Actual (reported)Children undergoing elective cardiac surgery requiring the use of cardiopulmonary bypass
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322, United States
Despotis GJ, Levine V, Joist JH, Joiner-Maier D, Spitznagel E. Antithrombin III during cardiac surgery: effect on response of activated clotting time to heparin and relationship to markers of hemostatic activation. Anesth Analg. 1997 Sep;85(3):498-506. doi: 10.1097/00000539-199709000-00005.
Andrew M, Paes B, Johnston M. Development of the hemostatic system in the neonate and young infant. Am J Pediatr Hematol Oncol. 1990 Spring;12(1):95-104. doi: 10.1097/00043426-199021000-00019.
Nina A Guzzetta, MD
Emory University
First Submitted
September 12, 2005
First Posted
September 14, 2005
Study Start
December 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2006
Actual (reported)Contact the study team to confirm eligibility.
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.
McIntosh MA, Earhart CF. Coordinate regulation by iron of the synthesis of phenolate compounds and three outer membrane proteins in Escherichia coli. J Bacteriol. 1977 Jul;131(1):331-9. doi: 10.1128/jb.131.1.331-339.1977.
Study Completion
May 2006
Actual (reported)Last Updated
November 20, 2013
Record last verified: 2013-11
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