Recombinant human factor VIIa prevents hysterectomy in severe postpartum hemorrhage: single center study

Abstract

Objective: To evaluate the effectiveness of human recombinant activated factor VII (rhFVIIa, NovoSeven) in avoiding hysterectomy postpartum in the management of severe postpartum hemorrhage (PPH). Methods: We performed a prospective cohort study at our university tertiary care center. Patients with severe post partum hemorrhage (blood loss > 2000 mL) and failed medical and uterus-preserving surgical management, were treated with intravenous bolus administration of rhVIIa. Main outcome measures were cessation of bleeding, postpartum hysterectomy and thromboembolic events. Results: In 20/22 patients included, PPH was caused primarily by uterine atony, including 7 (32 % ) with additional lower genital tract lesion; in two women, it was due to pathologic placentation (placenta increta, 9 % ). One case of amniotic fl uid embolism and one woman with uterine inversion were included. Recombinant hFVIIa was successful in stopping the PPH and in preventing a hysterectomy in 20/22 women (91 % ). The remaining two patients with persistent bleeding despite rhFVIIa treatment, who underwent postpartum hysterectomy, had placenta increta. No thromboembolic event was noticed. Conclusions: This study describes the largest single center series of rhFVIIa treatment for fertility preservation in severe postpartum hemorrhage published to date. Our data suggest that administration of rhFVIIa is effective in avoiding postpartum hysterectomy after conservative medical and surgical measures have failed. Although randomized studies are lacking, rhFVIIa should be considered as a second-line therapeutic option of life-threatening postpartal bleeding, in particular if preservation of fertility is warranted and hysterectomy is to be avoided.

Patient blood management (PBM) in pregnancy and childbirth: literature review and expert opinion

“…If haemorrhage could not be controlled by other measures, rhFVIIa could lower the need of second-line therapies [101]. In a prospective cohort study with 22 patients with severe PPH rhVIIa contributed to the control of PPH and hysterectomy was avoided [102]. In life-threatening PPH, rFVIIa administration might be used.…”

Patient’s blood management in obstetric practice with placenta accrete

“…Отдельно следует сказать об использовании гемостатических препаратов направленного действия, каким является рекомбинантный активированный VII фактор коагуляции (rFVIIa), который стал использоваться в акушерской практике при развитии рефрактерных массивных кровотечений. Его применение показало снижение объема переливаемых компонентов крови и частоты выполнения гистерэктомии [20,21]. В настоящее время введение rFVIIa при жизнеугрожающих акушерских кровотечениях регламентировано рекомендациями Всемирной организации здравоохранения, Европейской ассоциации анестезиологов-реаниматологов, Британского королевского колледжа акушеров и гинекологов [22,23].…”

Use of Recombinant Factor VIIa in Obstetrics

“…The dose used in several reports where bleeding was successfully controlled with a dramatic reduction in transfusion requirements when other conventional treatments had failed varied from 20 to 120µgm/kg and there is no clear evidence of a dose-response relationship. 2,22,51,52,53 There have been no studies on the optimum dose of rFVIIa in obstetric haemorrhage. According to the consensus recommendations for the off-label use of rFVIIa therapy a mean dosage of 71µgm/kg was capable to arrest bleeding with the lowest dosage of 36 µgm/kg body weight.…”