Recombinant human FVIIa for reducing the need for invasive second-line therapies in severe refractory postpartum hemorrhage: a multicenter, randomized, open controlled trial
G Lavigne-Lissalde, A G Aya, F J Mercier, S Roger-Christoph, C Chauleur, E Morau, A S Ducloy-Bouthors, A Mignon, M Raucoules, A Bongain, F Boehlen, P de Moerloose, S Bouvet, P Fabbro-Peray, J-C Gris, G Lavigne-Lissalde, A G Aya, F J Mercier, S Roger-Christoph, C Chauleur, E Morau, A S Ducloy-Bouthors, A Mignon, M Raucoules, A Bongain, F Boehlen, P de Moerloose, S Bouvet, P Fabbro-Peray, J-C Gris
Abstract
Background: Case reports on recombinant human factor VIIa (rhuFVIIa) use in women with severe postpartum hemorrhage (PPH) showed encouraging results, but no randomized controlled trial (RCT) is available.
Patients and methods: Eighty-four women with severe PPH unresponsive to uterotonics were randomized to receive one early single rhuFVIIa infusion (n = 42) or standard care (no rhuFVIIa; n = 42). The primary efficacy outcome measure was the reduction of the need for specific second-line therapies, such as interventional hemostatic procedures, for blood loss and transfusions. The primary safety outcome measure was the number of deaths and thrombotic events during the 5 days following rhuFVIIa infusion.
Results: rhuFVIIa was associated with a reduction in the number of patients who needed second-line therapies compared with controls (standard care). Specifically, 39/42 (93%) patients in the standard care arm received second-line therapies and 22/42 (52%) patients in the rhuFVIIa arm (absolute difference, 41%; range, 18-63%; relative risk RR, 0.56 [0.42-0.76]). The delivery mode (vaginal or Cesarean section) did not affect the primary outcome. No death occurred. Two venous thrombotic events were recorded in the rhuFVIIa arm: one ovarian vein thrombosis and one deep vein thrombosis with a non-severe pulmonary embolism.
Conclusion: This open RCT in women with severe PPH refractory to uterotonics shows that rhuFVIIa reduces the need for specific second-line therapies in about one in three patients, with the occurrence of non-fatal venous thrombotic events in one in 20 patients.
Trial registration: ClinicalTrials.gov NCT00370877.
Keywords: FVIIa activated; hysterectomy; postpartum hemorrhage; treatment efficacy; treatment outcome.
© 2015 International Society on Thrombosis and Haemostasis.
Source: PubMed