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A Pilot Study of Antithrombin Replacement Prior to Cardiopulmonary Bypass in Neonates. Artif Organs 2016 Jan;40(1):80-5

Date

12/02/2015

Pubmed ID

26620919

DOI

10.1111/aor.12642

Scopus ID

2-s2.0-84956825530   7 Citations

Abstract

Neonates have low levels of antithrombin. Inadequate anticoagulation during cardiopulmonary bypass (CPB) due to low antithrombin activity may result in a poor preservation of the coagulation system during bypass. We hypothesize that antithrombin replacement to neonates prior to CPB will preserve the hemostatic system and result in less postoperative bleeding. A randomized, double-blinded, placebo-controlled pilot study of antithrombin replacement to neonates prior to CPB was conducted. Preoperative antithrombin levels determined the dose of recombinant antithrombin or placebo to be given. Antithrombin levels were measured following the dosing of the antithrombin/placebo, after initiation of bypass, near the completion of bypass, and upon intensive care unit admission. Eight subjects were enrolled. No subject had safety concerns. Mediastinal exploration occurred in two antithrombin subjects and one placebo subject. Antithrombin activity levels were significantly higher in the treated group following drug administration; levels continued to be higher than preoperatively but not different from the placebo group at all other time points. Total heparin administration was less in the antithrombin group; measurements of blood loss were similar in both groups. A single dose of recombinant antithrombin did not maintain 100% activity levels throughout the entire operation. Although no safety concerns were identified in this pilot study, a larger trial is necessary to determine clinical efficacy.

Author List

Niebler RA, Woods KJ, Murkowski K, Ghanayem NS, Hoffman G, Mitchell ME, Punzalan RC, Scott JP, Simpson P, Tweddell JS

Authors

George M. Hoffman MD Chief, Professor in the Anesthesiology department at Medical College of Wisconsin
Michael Edward Mitchell MD Professor in the Surgery department at Medical College of Wisconsin
Robert Niebler MD Associate Professor in the Pediatrics department at Medical College of Wisconsin
Rowena C. Punzalan MD Associate Professor in the Pediatrics department at Medical College of Wisconsin
John P. Scott MD Associate Professor in the Anesthesiology department at Medical College of Wisconsin
John Paul Scott MD Professor in the Pediatrics department at Medical College of Wisconsin
Pippa M. Simpson PhD Chief, Professor in the Pediatrics department at Medical College of Wisconsin
Katherine Woods in the CTSI department at Medical College of Wisconsin - CTSI




MESH terms used to index this publication - Major topics in bold

Anticoagulants
Antithrombin III
Blood Coagulation
Blood Coagulation Tests
Cardiopulmonary Bypass
Double-Blind Method
Feasibility Studies
Heart Defects, Congenital
Heparin
Humans
Infant, Newborn
Pilot Projects
Postoperative Hemorrhage
Recombinant Proteins
Time Factors
Treatment Outcome
Wisconsin
jenkins-FCD Prod-482 91ad8a360b6da540234915ea01ff80e38bfdb40a