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Double-Blind, Randomized, Placebo-Controlled Trial Comparing the Effects of Antithrombin Versus Placebo on the Coagulation System in Infants with Low Antithrombin Undergoing Congenital Cardiac Surgery.

Publication ,  Journal Article
Jooste, EH; Scholl, R; Wu, Y-H; Jaquiss, RDB; Lodge, AJ; Ames, WA; Homi, HM; Machovec, KA; Greene, NH; Donahue, BS; Shah, N; Benkwitz, C
Published in: J Cardiothorac Vasc Anesth
February 2019

OBJECTIVES: To determine whether precardiopulmonary bypass (CPB) normalization of antithrombin levels in infants to 100% improves heparin sensitivity and anticoagulation during CPB and has beneficial effects into the postoperative period. DESIGN: Randomized, double-blinded, placebo-controlled prospective study. SETTING: Multicenter study performed in 2 academic hospitals. PARTICIPANTS: The study comprised 40 infants younger than 7 months with preoperative antithrombin levels <70% undergoing CPB surgery. INTERVENTIONS: Antithrombin levels were increased with exogenous antithrombin to 100% functional level intraoperatively before surgical incision. MEASUREMENTS AND MAIN RESULTS: Demographics, clinical variables, and blood samples were collected up to postoperative day 4. Higher first post-heparin activated clotting times (sec) were observed in the antithrombin group despite similar initial heparin dosing. There was an increase in heparin sensitivity in the antithrombin group. There was significantly lower 24-hour chest tube output (mL/kg) in the antithrombin group and lower overall blood product unit exposures in the antithrombin group as a whole. Functional antithrombin levels (%) were significantly higher in the treatment group versus placebo group until postoperative day 2. D-dimer was significantly lower in the antithrombin group than in the placebo group on postoperative day 4. CONCLUSION: Supplementation of antithrombin in infants with low antithrombin levels improves heparin sensitivity and anticoagulation during CPB without increased rates of bleeding or adverse events. Beneficial effects may be seen into the postoperative period, reflected by significantly less postoperative bleeding and exposure to blood products and reduced generation of D-dimers.

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Published In

J Cardiothorac Vasc Anesth

DOI

EISSN

1532-8422

Publication Date

February 2019

Volume

33

Issue

2

Start / End Page

396 / 402

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Prospective Studies
  • Preoperative Care
  • Postoperative Hemorrhage
  • Male
  • Infant, Newborn
  • Humans
  • Heart Defects, Congenital
  • Follow-Up Studies
  • Female
 

Citation

APA
Chicago
ICMJE
MLA
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Jooste, E. H., Scholl, R., Wu, Y.-H., Jaquiss, R. D. B., Lodge, A. J., Ames, W. A., … Benkwitz, C. (2019). Double-Blind, Randomized, Placebo-Controlled Trial Comparing the Effects of Antithrombin Versus Placebo on the Coagulation System in Infants with Low Antithrombin Undergoing Congenital Cardiac Surgery. J Cardiothorac Vasc Anesth, 33(2), 396–402. https://doi.org/10.1053/j.jvca.2018.05.052
Jooste, Edmund H., Rebecca Scholl, Yi-Hung Wu, Robert D. B. Jaquiss, Andrew J. Lodge, Warwick A. Ames, H Mayumi Homi, et al. “Double-Blind, Randomized, Placebo-Controlled Trial Comparing the Effects of Antithrombin Versus Placebo on the Coagulation System in Infants with Low Antithrombin Undergoing Congenital Cardiac Surgery.J Cardiothorac Vasc Anesth 33, no. 2 (February 2019): 396–402. https://doi.org/10.1053/j.jvca.2018.05.052.
Jooste, Edmund H., et al. “Double-Blind, Randomized, Placebo-Controlled Trial Comparing the Effects of Antithrombin Versus Placebo on the Coagulation System in Infants with Low Antithrombin Undergoing Congenital Cardiac Surgery.J Cardiothorac Vasc Anesth, vol. 33, no. 2, Feb. 2019, pp. 396–402. Pubmed, doi:10.1053/j.jvca.2018.05.052.
Jooste EH, Scholl R, Wu Y-H, Jaquiss RDB, Lodge AJ, Ames WA, Homi HM, Machovec KA, Greene NH, Donahue BS, Shah N, Benkwitz C. Double-Blind, Randomized, Placebo-Controlled Trial Comparing the Effects of Antithrombin Versus Placebo on the Coagulation System in Infants with Low Antithrombin Undergoing Congenital Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):396–402.
Journal cover image

Published In

J Cardiothorac Vasc Anesth

DOI

EISSN

1532-8422

Publication Date

February 2019

Volume

33

Issue

2

Start / End Page

396 / 402

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Prospective Studies
  • Preoperative Care
  • Postoperative Hemorrhage
  • Male
  • Infant, Newborn
  • Humans
  • Heart Defects, Congenital
  • Follow-Up Studies
  • Female