ABSTRACT
OBJECTIVE: The utilization, during pregnancy, of low molecular weight heparin (enoxaparine) for obstetric thromboprophylaxis for patients with activated protein C resistance, following Factor V Leiden mutation. STUDY DESIGN: Prospective study enrolling 10 pregnant patients heterozygote or homozygote for Factor V Leiden mutation. They all had familial or personal history of severe thrombotic disease and received 40 mg per day of enoxaparine. RESULTS: No thrombosis or hemorrhage were recorded during pregnancies or deliveries. All the infants were doing well. After birth, low molecular, weight heparin were continued between 6 to 12 weeks accordingly allelic status and history. We reviewed the literature on this subject. CONCLUSION: This series confirmed the efficacy, safety and tolerance of low molecular weight heparins which will probably become the next gold standard for obstetric thromboprophylaxis.
Subject(s)
Activated Protein C Resistance/drug therapy , Anticoagulants/therapeutic use , Enoxaparin/therapeutic use , Pregnancy Complications, Hematologic/drug therapy , Venous Thrombosis/prevention & control , Activated Protein C Resistance/genetics , Adult , Factor V/genetics , Female , Humans , Point Mutation , Pregnancy , Pregnancy OutcomeABSTRACT
A double blind randomized cross-over multi-center study has been conducted to compare the pharmacokinetic and coagulation activation markers of high-purity factor IX concentrate subjected to both solvent/ detergent (SD) treatment and 15 nm-filtration (FIX-SD-15) with the licensed product subjected only to solvent-detergent (FIX-SD). This filtration process allows the elimination of small particles, such as non-enveloped viruses (i.e., hepatitis A and parvovirus B19). Eleven severe hemophilia B patients (FIX coagulant activity <2 IU/dl) received one infusion of 60 IU/kg of FIX-SD and one infusion of 60 IU/kg of FIX-SD-15 at least at 10 days interval. Blood samples were obtained before and at various time up to 72 h after infusion. The decay curves of factor IX (FIX:C and FIX:Ag) were evaluated by a model independent method. Bioequivalence was found between the two concentrates using the Schuirmann test. The mean FIX:C and FIX:Ag recovery of FIX-SD-15 was 1.08 and 0.89 IU/dl/IU/kg respectively with a mean half-life of 33.3 h for FIX:C and 25.6 h for FIX:Ag. Six months after initial enrollment, pharmacokinetic parameters were similar in the 7 patients tested. There was no significant variation of prothrombin fragment 1+2 and thrombin-antithrombin complexes measured up to 6 h after infusion, indicating that there was no activation process after administration of FIX. In conclusion, these data demonstrate that the introduction of a 15 nm filtration does not alter the pharmacokinetic profile of a well characterized SD FIX concentrate while providing additional viral safety.