title: Recombinant Human Antithrombin in Pregnant Patients with Hereditary Antithrombin Deficiency: Integrated Analysis of Clinical Data.
abstract: OBJECTIVE
  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).
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Yale Women and Children's Center for Blood Disorders and Preeclampsia Advancement, Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Paidas
authors.affiliation: Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island.
authors.forename: Elizabeth W
authors.initials: EW
authors.lastname: Triche
authors.affiliation: Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina.
authors.forename: Andra H
authors.initials: AH
authors.lastname: James
authors.affiliation: Division of Hematology-Oncology, Weill Cornell Medical Center, New York, New York.
authors.forename: Maria
authors.initials: M
authors.lastname: DeSancho
authors.affiliation: Department of Obstetrics and Gynecology, University of South Carolina, Columbia, South Carolina.
authors.forename: Christopher
authors.initials: C
authors.lastname: Robinson
authors.affiliation: Department of Pathology and Laboratory Medicine, Medical University of South Carolina, Charleston, South Carolina.
authors.forename: John
authors.initials: J
authors.lastname: Lazarchick
authors.affiliation: Yale Women and Children's Center for Blood Disorders and Preeclampsia Advancement, Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Sara
authors.initials: S
authors.lastname: Ornaghi
authors.affiliation: Department of Clinical Development, rEVO Biologics, Framingham, Massachusetts.
authors.forename: Johan
authors.initials: J
authors.lastname: Frieling
mesh_terms: D000328:Adult; D000925:Anticoagulants / Q000008:administration & dosage*; D000990:Antithrombin III / Q000008:administration & dosage*; D020152:Antithrombin III Deficiency / Q000188:drug therapy*; D005260:Female; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D038622:Internationality; D058725:Peripartum Period; D011247:Pregnancy; D011994:Recombinant Proteins / Q000008:administration & dosage; D020246:Venous Thrombosis / Q000453:epidemiology / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D006495:Heparin, Low-Molecular-Weight; D011994:Recombinant Proteins; D000990:Antithrombin III