2015
DOI: 10.1111/jth.12844
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Recombinant human FVIIa for reducing the need for invasive second‐line therapies in severe refractory postpartum hemorrhage: a multicenter, randomized, open controlled trial

Abstract: 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, suc… Show more

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Cited by 71 publications
(37 citation statements)
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“…A recent RCT of rFVIIa (60 mcg/kg) use in women with PPH refractory to uterotonics demonstrated reduced need for interventional secondline therapies in a third of patients, with nonfatal venous thrombosis in 1 in 20. 67 Platelet and fibrinogen thresholds of .50 3 10 9 /L and .1 g/L, respectively, were ensured. rFVIIa is used occasionally in our center when hemorrhage has not been controlled by other means and has avoided the need for hysterectomy.…”
Section: Recombinant Fviiamentioning
confidence: 99%
“…A recent RCT of rFVIIa (60 mcg/kg) use in women with PPH refractory to uterotonics demonstrated reduced need for interventional secondline therapies in a third of patients, with nonfatal venous thrombosis in 1 in 20. 67 Platelet and fibrinogen thresholds of .50 3 10 9 /L and .1 g/L, respectively, were ensured. rFVIIa is used occasionally in our center when hemorrhage has not been controlled by other means and has avoided the need for hysterectomy.…”
Section: Recombinant Fviiamentioning
confidence: 99%
“…To be effective, rhVIIa requires correction of hypothermia, acidosis, fibrinogen levels, and anaemia [100]. 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].…”
Section: Recombinant Activated Human Factor VII (Rhfviia)mentioning
confidence: 99%
“…Randomized trials investigating PPH treatments have used a range of blood loss volumes in their inclusion criteria, to identify women that could benefit from treatment: 500 ml [11], [12], [13], [14], 700 ml [15], [16], 800 ml [17], 1000 ml [18] and 1500 ml [19]. Other authors have used a fall in haemoglobin or haematocrit as a definition, to avoid the difficulties of measurement or estimation of blood loss [20], [21].…”
Section: Preamblementioning
confidence: 99%