A Pilot Study of Antithrombin Replacement Prior to Cardiopulmonary Bypass in Neonates

Artificial Organs - Tập 40 Số 1 - Trang 80-85 - 2016
Robert A. Niebler1,2, Katherine Woods2, Kathleen Murkowski2, Nancy S. Ghanayem1,2, George M. Hoffman3,1, Michael E. Mitchell4,1, Rowena C. Punzalan5, John P. Scott5, Pippa Simpson6, James S. Tweddell4,1
1Herma Heart Center at Children's Hospital of Wisconsin, Milwaukee, WI, USA
2Section of Critical Care, Medical College of Wisconsin, Milwaukee, WI, USA
3Department of Anesthesiology, Medical College of Wisconsin, Milwaukee, WI. USA
4Department of Cardiothoracic Surgery, Medical College of Wisconsin, Milwaukee, WI, USA
5Section of Hematology, Medical College of Wisconsin, Milwaukee, WI, USA
6Section of Quantitative Health Sciences, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI, USA

Tóm tắt

AbstractNeonates 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.

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