Patients with hereditary antithrombin (AT) deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures. The trial is focusing on patients with confirmed hereditary antithrombin deficiency who are undergoing a surgical procedure or induced/spontaneous labor and delivery. The study will test the safety and efficacy of recombinant human antithrombin (rhAT) by infusing rhAT prior to, during and following the period of risk or surgical procedure.
Name: Recombinant Human Antithrombin (rhAT)Description: Biological/Vaccine: Recombinant human antithrombin(rhAT) Phase III clinical trial.Type: Biological
Recombinant Human Antithrombin (rhAT) infusion
Description: Observation for clinical signs and symptoms of thromboembolic events are evaluated for acute deep vein thrombosis (DVT) using duplex ultrasonography and/or other imaging tests to confirm clinical signs/symptoms. Duplex ultrasonography was performed at baseline, last day of dosing and day 7 (+ or -1 day).Measure: Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Vein Thrombosis (DVT). Time: Baseline, last day of dosing and day 7 (+ or - 1 day)
Description: The investigators evaluated patients for any clinical signs of thromboembolism by physical examination.Measure: Local Assessment of Thromboembolism by Physical Examination. Time: 30 days after last dose
Single Group Assignment
There is one SNP
Exclusion Criteria: - Patients who have a diagnosis of hereditary APC resistance, Factor V Leiden, Protein S or C deficiency, prothrombin gene mutation (G20210A), or acquired (lupus anticoagulant) thrombophilic disorder. --- G20210A ---