Premium
Recombinant human FVIIa for reducing the need for invasive second‐line therapies in severe refractory postpartum hemorrhage: a multicenter, randomized, open controlled trial
Author(s) -
LavigneLissalde G.,
Aya A. G.,
Mercier F. J.,
RogerChristoph S.,
Chauleur C.,
Morau E.,
DucloyBouthors A. S.,
Mig A.,
Raucoules M.,
Bongain A.,
Boehlen F.,
Moerloose P.,
Bouvet S.,
FabbroPeray P.,
Gris J.C.
Publication year - 2015
Publication title -
journal of thrombosis and haemostasis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.947
H-Index - 178
eISSN - 1538-7836
pISSN - 1538-7933
DOI - 10.1111/jth.12844
Subject(s) - medicine , randomized controlled trial , pulmonary embolism , thrombosis , deep vein , refractory (planetary science) , surgery , venous thrombosis , physics , astrobiology
Summary Background Case reports on recombinant human factor VII a (rhu FVII a) 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 rhu FVII a infusion ( n = 42) or standard care (no rhu FVII a; 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 rhu FVII a infusion. Results rhu FVII a 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 rhu FVII a 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 rhu FVII a 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 rhu FVII a 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.