Exploring the Role of Antithrombin Replacement for the Treatment of Preeclampsia: A Prospective Randomized Evaluation of the Safety and Efficacy of Recombinant Antithrombin in Very Preterm Preeclampsia (PRESERVE-1)

Problem Antithrombin (AT) replacement has been described in patients with hereditary AT deficiency undergoing delivery; however, the kinetics of AT replacement in preeclampsia is not adequately understood. Therefore, the Prospective Randomized Evaluation of the Safety and Efficacy of Recombinant Antithrombin in Very Preterm Preeclampsia (PRESERVE‐1) study has been proposed. Methods Sixty women aged ≥18 years at 24 0/7–28 0/7 weeks' gestation and with hypertension and proteinuria will be enrolled and randomly assigned to receive recombinant human AT or placebo until fetal and/or maternal indications cause cessation of expectant management or until 34 0/7 weeks' gestation. The primary endpoint is the increase in gestational age from randomization to delivery. Safety assessments and laboratory assays will also be performed. Results PRESERVE‐1 study enrollment will begin during the second half of 2013. Conclusion The PRESERVE‐1 study will provide further insight into the pharmacokinetic activity and safety of AT therapy in preeclampsia.