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Recombinant Human Antithrombin in Pregnant Patients with Hereditary Antithrombin Deficiency: Integrated Analysis of Clinical Data.

Publication ,  Journal Article
Paidas, MJ; Triche, EW; James, AH; DeSancho, M; Robinson, C; Lazarchick, J; Ornaghi, S; Frieling, J
Published in: Am J Perinatol
March 2016

OBJECTIVES: The purpose of this analysis was to evaluate the use of recombinant human antithrombin (rhAT) in preventing venous thromboembolism (VTE) in pregnant patients with hereditary AT deficiency (HATD). STUDY DESIGN: Data from two clinical trials were pooled. Dosing of rhAT was based on body weight and baseline AT activity, started up to 24 hours before scheduled induction or cesarean delivery, or at the onset of labor. RESULTS: A total of 21 pregnant HATD patients were enrolled. Mean rhAT therapy duration was 4.3 days and dose was 245.1 IU/kg/day. All patients achieved target mean AT activity (80-120% of normal) during rhAT therapy. There were no confirmed VTEs during rhAT treatment or within 7 ( ± 1) days after dosing. Two VTE events (one deep vein thrombosis and one pulmonary embolism) occurred 11 and 14 days after discontinuation of rhAT, in patients managed with prophylactic doses of heparin or low-molecular-weight heparin following delivery. CONCLUSION: rhAT was safe and effective in pregnant HATD patients when administered during the peripartum period, the period of highest VTE risk and a time when anticoagulation therapy is normally withheld. Pregnant HATD patients may benefit from therapeutic, rather than prophylactic, doses of anticoagulation after delivery to protect against postpartum VTE.

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Published In

Am J Perinatol

DOI

EISSN

1098-8785

Publication Date

March 2016

Volume

33

Issue

4

Start / End Page

343 / 349

Location

United States

Related Subject Headings

  • Young Adult
  • Venous Thrombosis
  • Recombinant Proteins
  • Pregnancy
  • Peripartum Period
  • Obstetrics & Reproductive Medicine
  • Internationality
  • Humans
  • Heparin, Low-Molecular-Weight
  • Female
 

Citation

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Paidas, M. J., Triche, E. W., James, A. H., DeSancho, M., Robinson, C., Lazarchick, J., … Frieling, J. (2016). Recombinant Human Antithrombin in Pregnant Patients with Hereditary Antithrombin Deficiency: Integrated Analysis of Clinical Data. Am J Perinatol, 33(4), 343–349. https://doi.org/10.1055/s-0035-1564423
Paidas, Michael J., Elizabeth W. Triche, Andra H. James, Maria DeSancho, Christopher Robinson, John Lazarchick, Sara Ornaghi, and Johan Frieling. “Recombinant Human Antithrombin in Pregnant Patients with Hereditary Antithrombin Deficiency: Integrated Analysis of Clinical Data.Am J Perinatol 33, no. 4 (March 2016): 343–49. https://doi.org/10.1055/s-0035-1564423.
Paidas MJ, Triche EW, James AH, DeSancho M, Robinson C, Lazarchick J, et al. Recombinant Human Antithrombin in Pregnant Patients with Hereditary Antithrombin Deficiency: Integrated Analysis of Clinical Data. Am J Perinatol. 2016 Mar;33(4):343–9.
Paidas, Michael J., et al. “Recombinant Human Antithrombin in Pregnant Patients with Hereditary Antithrombin Deficiency: Integrated Analysis of Clinical Data.Am J Perinatol, vol. 33, no. 4, Mar. 2016, pp. 343–49. Pubmed, doi:10.1055/s-0035-1564423.
Paidas MJ, Triche EW, James AH, DeSancho M, Robinson C, Lazarchick J, Ornaghi S, Frieling J. Recombinant Human Antithrombin in Pregnant Patients with Hereditary Antithrombin Deficiency: Integrated Analysis of Clinical Data. Am J Perinatol. 2016 Mar;33(4):343–349.
Journal cover image

Published In

Am J Perinatol

DOI

EISSN

1098-8785

Publication Date

March 2016

Volume

33

Issue

4

Start / End Page

343 / 349

Location

United States

Related Subject Headings

  • Young Adult
  • Venous Thrombosis
  • Recombinant Proteins
  • Pregnancy
  • Peripartum Period
  • Obstetrics & Reproductive Medicine
  • Internationality
  • Humans
  • Heparin, Low-Molecular-Weight
  • Female