Antithrombin III Supplementation for Cardiopulmonary Bypass in Neonates
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01158729|
Recruitment Status : Terminated (Grant funding expired, poor patient enrollment)
First Posted : July 8, 2010
Last Update Posted : January 20, 2014
Medical College of Wisconsin
Children's National Research Institute
Information provided by (Responsible Party):
Robert Niebler, Medical College of Wisconsin
No Study Results Posted on ClinicalTrials.gov for this Study
|Recruitment Status :||Terminated|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Murphy GJ, Reeves BC, Rogers CA, Rizvi SI, Culliford L, Angelini GD. Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation. 2007 Nov 27;116(22):2544-52. Epub 2007 Nov 12.
Engoren MC, Habib RH, Zacharias A, Schwann TA, Riordan CJ, Durham SJ. Effect of blood transfusion on long-term survival after cardiac operation. Ann Thorac Surg. 2002 Oct;74(4):1180-6.
Spiess BD, Royston D, Levy JH, Fitch J, Dietrich W, Body S, Murkin J, Nadel A. Platelet transfusions during coronary artery bypass graft surgery are associated with serious adverse outcomes. Transfusion. 2004 Aug;44(8):1143-8.
Chambers LA, Cohen DM, Davis JT. Transfusion patterns in pediatric open heart surgery. Transfusion. 1996 Feb;36(2):150-4.
Petäjä J, Lundström U, Leijala M, Peltola K, Siimes MA. Bleeding and use of blood products after heart operations in infants. J Thorac Cardiovasc Surg. 1995 Mar;109(3):524-9.
Evans DA, Holder RL, Brawn WJ, Sethia B. Post-operative blood loss following cardio-pulmonary bypass in children. Eur J Cardiothorac Surg. 1994;8(1):25-9.
Bick RL. Alterations of hemostasis associated with cardiopulmonary bypass: pathophysiology, prevention, diagnosis, and management. Semin Thromb Hemost. 1976 Oct;3(2):59-82. Review.
Rosenberg RD. Biochemistry of heparin antithrombin interactions, and the physiologic role of this natural anticoagulant mechanism. Am J Med. 1989 Sep 11;87(3B):2S-9S. Review.
Villaneuva GB, Danishefsky I. Evidence for a heparin-induced conformational change on antithrombin III. Biochem Biophys Res Commun. 1977 Jan 24;74(2):803-9.
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.
Andrew M, Paes B, Milner R, Johnston M, Mitchell L, Tollefsen DM, Castle V, Powers P. Development of the human coagulation system in the healthy premature infant. Blood. 1988 Nov;72(5):1651-7.
Odegard KC, Zurakowski D, Hornykewycz S, DiNardo JA, Castro RA, Neufeld EJ, Laussen PC. Evaluation of the coagulation system in children with two-ventricle congenital heart disease. Ann Thorac Surg. 2007 May;83(5):1797-803.
Hakacova N, Laluhova-Striezencova Z, Zahorec M. Disturbances of coagulation in neonates with functionally univentricular physiology prior to the first stage of surgical reconstruction. Cardiol Young. 2008 Aug;18(4):397-401. doi: 10.1017/S1047951108002400. Epub 2008 Jun 18.
Odegard KC, Zurakowski D, DiNardo JA, Castro RA, McGowan FX Jr, Neufeld EJ, Laussen PC. Prospective longitudinal study of coagulation profiles in children with hypoplastic left heart syndrome from stage I through Fontan completion. J Thorac Cardiovasc Surg. 2009 Apr;137(4):934-41. doi: 10.1016/j.jtcvs.2008.09.031. Epub 2009 Feb 23.
Avidan MS, Levy JH, Scholz J, Delphin E, Rosseel PM, Howie MB, Gratz I, Bush CR, Skubas N, Aldea GS, Licina M, Bonfiglio LJ, Kajdasz DK, Ott E, Despotis GJ. A phase III, double-blind, placebo-controlled, multicenter study on the efficacy of recombinant human antithrombin in heparin-resistant patients scheduled to undergo cardiac surgery necessitating cardiopulmonary bypass. Anesthesiology. 2005 Feb;102(2):276-84.
Avidan MS, Levy JH, van Aken H, Feneck RO, Latimer RD, Ott E, Martin E, Birnbaum DE, Bonfiglio LJ, Kajdasz DK, Despotis GJ. Recombinant human antithrombin III restores heparin responsiveness and decreases activation of coagulation in heparin-resistant patients during cardiopulmonary bypass. J Thorac Cardiovasc Surg. 2005 Jul;130(1):107-13.
Koster A, Chew D, Kuebler W, Habazettl H, Hetzer R, Kuppe H. High antithrombin III levels attenuate hemostatic activation and leukocyte activation during cardiopulmonary bypass. J Thorac Cardiovasc Surg. 2003 Sep;126(3):906-7.
Lemmer JH Jr, Despotis GJ. Antithrombin III concentrate to treat heparin resistance in patients undergoing cardiac surgery. J Thorac Cardiovasc Surg. 2002 Feb;123(2):213-7.
Rinder CS, Rinder HM, Smith MJ, Fitch JC, Tracey JB, Chandler WL, Rollins SA, Smith BR. Antithrombin reduces monocyte and neutrophil CD11b up regulation in addition to blocking platelet activation during extracorporeal circulation. Transfusion. 2006 Jul;46(7):1130-7.
Jaggers J, Lawson JH. Coagulopathy and inflammation in neonatal heart surgery: mechanisms and strategies. Ann Thorac Surg. 2006 Jun;81(6):S2360-6. Review.