• Incidence of occurence of any thromboembolic event [ Time Frame: 7 days of discontinuation of treatment wth rhAT ] [ Designated as safety issue: No ]

  The first outcome assessment is a clinical diagnosis of the occurrence of acute DVT. An acute DVT will be considered to have occurred if, during rhAT treatment or within 7 days of discontinuation of treatment with rhAT.

  The second outcome assessment is a clinical diagnosis of the occurrence of a thromboembolic event other than DVT (e.g., pulmonary embolism). A thromboembolic event other than DVT will be considered to have occurred if, during rhAT treatment or within 7 days of discontinuation of treatment with rhAT.

  
  

Biological: Recombinant human antithrombin
Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient will receive an initial intravenous loading dose followed by a continuous intravenous infusion of rhAT that will target and maintain an AT activity that is > 80% and < 120% of normal. The dosing objective for all study patients is maintenance of the AT activity at > 80% and < 120% of normal during the high-risk period for thromboembolic events. Dosing and dose adjustments will be based on the results of AT activity determinations performed prior to and during treatment.
Other Name: ATryn

GTC will establish a clinical trial site in any location in Europe, Canada and the US depending on the needs of the physician and the patient. To provide this flexibility, GTC has an international clinical team to support site registration requirements once a patient has been identified for treatment. We also provide consultation to help evaluate patient eligibility.

In September 2006, GTC modified exclusion criteria 1 (below) to allow for the participation of previously excluded patients with the hereditary thrombophilic disorders Factor V Leiden and prothrombin gene mutation (G20210A).