Recombinant human FVIIa for reducing the need for invasive second‐line therapies in severe refractory postpartum hemorrhage: a multicenter, randomized, open controlled trial

Summary 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...

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Bibliographic Details
Published in:Journal of thrombosis and haemostasis 2015-04, Vol.13 (4), p.520-529
Main Authors: Lavigne‐Lissalde, G., Aya, A. G., Mercier, F. J., Roger‐Christoph, S., Chauleur, C., Morau, E., Ducloy‐Bouthors, A. S., Mignon, A., Raucoules, M., Bongain, A., Boehlen, F., Moerloose, P., Bouvet, S., Fabbro‐Peray, P., Gris, J.‐C.
Format: Article
Language:English
Subjects:
Adult
Coagulants - administration & dosage
Coagulants - adverse effects
Coagulants - therapeutic use
Compassionate Use Trials
Dinoprostone - analogs & derivatives
Dinoprostone - therapeutic use
Drug Administration Schedule
Factor XIIa
Female
France
FVIIa activated
Hematology
Hemostatic Techniques - adverse effects
Human health and pathology
Humans
Hysterectomy
Infusions, Intravenous
Life Sciences
postpartum hemorrhage
Postpartum Hemorrhage - diagnosis
Postpartum Hemorrhage - drug therapy
Postpartum Hemorrhage - mortality
Pregnancy
Risk Factors
Severity of Illness Index
Switzerland
Time Factors
treatment efficacy
Treatment Failure
treatment outcome
Venous Thrombosis - chemically induced
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Summary:Summary 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.
ISSN:1538-7933
1538-7836
1538-7836
DOI:10.1111/jth.12844