scholarly journals Experience with recombinant activated factor VII for severe post-partum hemorrhage in Japan, investigated by Perinatology Committee, Japan Society of Obstetrics and Gynecology

2015 ◽  
Vol 41 (8) ◽  
pp. 1161-1168 ◽  
Author(s):  
Maki Murakami ◽  
Takao Kobayashi ◽  
Takahiko Kubo ◽  
Toshiyuki Hata ◽  
Satoru Takeda ◽  
...  
2013 ◽  
Vol 54 (5) ◽  
pp. 289 ◽  
Author(s):  
Navneet Magon ◽  
KM Babu ◽  
Sanjiv Chopra ◽  
GurdarshanSingh Joneja ◽  
Krishan Kapur

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4507-4507
Author(s):  
Juan Herrada ◽  
Jeff T. Jobe ◽  
Kristin Long ◽  
Jobee Alvarade ◽  
Carmen Galvan

Abstract Background: Recombinant activated factor VII (rFVIIa) is a novel hemostatic agent, originally developed for the treatment of hemorrhage in hemophiliacs with inhibitors, which has been successfully used recently in an increasing number of nonhemophilic bleeding conditions. We report on the use of this hemostatic agent in a case of severe postpartum bleeding, associated with disseminated intravascular coagulation, and unresponsive to standard treatment. Case report: A healthy 39-year-old female presented with vaginal bleed and underwent emergency cesarean delivery of a full term baby. During the surgical procedure she was found to have an abruptio placentae, complicated with uncontrollable uterine bleeding that required a total hysterectomy. During the immediate post operative period the patient continued with profuse bleeding from the surgical wound. The diagnosis of clinical disseminated intravascular coagulopathy (DIC) was confirmed by the presence of thrombocytopenia, and a marked elevation of both prothrombin time (PT) and partial thromboplastin time (PTT) levels (both more than 100 seconds). During the first two postoperative days the patient required multiple transfusions of platelets, packed red blood cells (about 30 units), fresh frozen plasma, and cryoprecipitate. On the third postoperative day, she was taken to the operative room and a massive retroperitoneal clot was evacuated, although no specific bleeding site was found during the surgical exploration. After the procedure, and in addition to the usual hemostatic interventions, the patient was given three doses of rFVIIa (each dose consisted of 4.8 mg given intravenously over 2 minutes) over an eight-hour period. During the four subsequent days, the patient’s coagulopathy gradually improved, and eventually corrected. Although the clinical course was complicated with sepsis, renal failure, and respiratory failure, the patient was finally discharged home on stable condition twenty-six days after delivery. She is currently without any sequelae. Conclusion: Severe post partum bleeding unresponsive to standard hemostatic therapy is associated with a high mortality. This case suggests a potential role of rFVIIa in the management of this complex medical condition.


Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4434-4434
Author(s):  
Giovanni Barillari ◽  
Maria Grazia Frigo ◽  
Maddalena Casarotto ◽  
Antonio Farnia ◽  
Barbara Massè ◽  
...  

Abstract Abstract 4434 Introduction Major Post-Partum Haemorrhage (PPH) is a life-threatening labour complication, which mainly occurs without warning, predictive signs or symptoms and often in absence of predisposing conditions. Severe PPH is defined by an estimated blood loss during the first 24 hours post-partum, of more than 500mL in case of natural delivery and of more than 1000mL in case of caesarean section. In developed countries PPH incidence is reported between 0.5% and 2%. In these countries it is the third cause of maternal mortality, after venous thromboembolism (VTE) and hypertension. In developing countries, major PPH is cause of 120-000-150.000 maternal deaths every year. Therapeutic strategies for severe PPH management are largely standardized. Recombinant activated factor VII (rFVIIa) is an activated factor VII form, produced from factor VII cDNA transfected into hamster kidneys. The first case of rFVIIa administration during perioperative bleeding has been reported in 1999, since this time rFVIIa has been used as adjunctive therapy in the management of patients with life-threatening and critical haemorrhages caused by trauma, abdominal or cardiac surgery or urological surgery, liver transplantation, post partum and any other bleeding condition leading to impairment of haemostasis Purpose To report the Italian real experience in clinical practice, in order to provide wide and detailed clinical information about use of rFVIIa in the management of massive primary PPH in our country and in order to evaluate the role of haemostatic therapy in the management of this severe life- threatening obstetric complication, so contributing to treatment protocols development. Methods An Italian retrospective survey of severe primary PPH cases treated with rFVIIa was performed. Anamnestic, clinical and haemostatic data about fourty-three patients with PPH, from 2005 to 2007, were collected. Coagulative parameters and transfusion requirements before and after rFVIIa treatment were compared. Results After rFVIIa administration INR was significantly decreased, while fibrinogen levels were markedly increased. Median of packed red blood cells units, platelets units, fresh frozen plasma, crystalloids and colloids needed, before and after rFVIIa administration, were significantly decreased (tab.1). Thirty-four of 43 patients needed surgical intervention before rFVIIa administration, 11/43 after treatment. Hysterectomies have been performed respectively in 12/43 cases before and in 7/43 cases after rFVIIa infusion. The response to rFVIIa is shown in table 2 No maternal deaths have been reported. No adverse events or thromboembolic complications were observed. Conclusion rFVIIa administration represents a safe haemostatic approach in the management of severe PPH cases, when other conventional medical, surgical and radiology interventional approaches have not been successful. Data from Italian Registry, as well as from other case series, demonstrate the rFVIIa efficacy to reduce or stop obstetric critical bleeding. The use of rFVIIa as lifesaving therapy in cases, in which medical and surgical standard approach have failed, should be always considered as life well as uterus lifesaving treatment. Disclosures: Off Label Use: Safety and efficacy of rFVIIa in postpartum hemorrhage.


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4065-4065
Author(s):  
Giovanni Barillari ◽  

Abstract Introduction: Major Post Partum Haemorrhage (PPH) is a life threatening complication of labor, which mainly occurs without warning, predictive signs and symptoms and often in absence of predisposing conditions. A retrospective survey of cases of severe primary PPH treated with Recombinant Activated Factor VII (rFVIIa) in Italy, Greece, Spain and Portugal was performed. The aim of our study was to report the south european real experience in clinical practice about the use rFVIIa in PPH treatment. Methods: anamnestic, clinical and haemostatic data about fortyfive patients, treated between 2005 and 2007, were collected. Coagulative parameters and transfusion requirements before and after rFVIIa treatment were compared. Results: INR significantly decreased, while levels of fibrinogen markedly increased after rFVIIa administration. The median need of packed red blood cells units, platelets units, fresh frozen plasma and crystalloids and colloids, before and after rFVIIa administration, dramatically reduced being respectively 6 and 2 units (p<1.2exp-6), 1.5 and 0 units (p = 0.001), 1250 and 0 mL (p<4.4exp-5), 3000 and 1250mL (p<0,0042). No cases of adverse effects or thromboembolic complications were observed. Conclusions: Our clinical and haemostatic data suggest that recombinant activated factor VII may be a safe and helpful adjunctive therapy in the management of postpartum haemorrhage.


2009 ◽  
Vol 124 (6) ◽  
pp. e41-e47 ◽  
Author(s):  
Giovanni Barillari ◽  
Maria Grazia Frigo ◽  
Maddalena Casarotto ◽  
Antonio Farnia ◽  
Barbara Massè ◽  
...  

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