BACKGROUND: Severe or massive postpartum hemorrhage (PPH) has remained a leading cause of maternal mortality for decades across the world and it results in critical obstetric complications. Recombinant activated factor VII (rFVIIa) has emerged as a gold standard adjunctive hemostatic agent for the treatment of life-threatening PPH refractory to conventional therapies although it remains off-licensed for use in PPH. We studied the effects of rFVIIa on coagulopathy, transfusion volume, prognosis, severity change in Korean PPH patients. METHODS: A retrospective review of medical records between December 2008 and March 2011 indicating use of rFVIIa in severe PPH was performed. We compared age, rFVIIa treatment, transfusion volume, and Sequential Organ Failure Assessment (SOFA) score at the time of arrival in the emergency department and after 24 hours for patients whose SOFA score was 8 points or higher. RESULTS: Fifteen women with SOFA score of 8 and above participated in this study and eight received rFVIIa administration whereas seven did not. Patients' mean age was 31.7 ± 7.5 years. There was no statistically significant difference in initial and post-24 hours SOFA scores between patients administered rFVIIa or not. The change in SOFA score between initial presentation and after 24 hours was significantly reduced after rFVIIa administration (P = 0.016). CONCLUSIONS: This analysis aimed to support that the administration of rFVIIa can reduce the severity of life-threatening PPH in patients. A rapid decision regarding the administration of rFVIIa is needed for a more favorable outcome in severe PPH patients for whom there is no effective standard treatment.
Emergency Service, Hospital ; Factor VIIa* ; Female ; Humans ; Maternal Death ; Maternal Mortality ; Medical Records ; Organ Dysfunction Scores ; Postpartum Hemorrhage* ; Postpartum Period* ; Prognosis ; Recombinant Proteins ; Retrospective Studies

BACKGROUND: Severe or massive postpartum hemorrhage (PPH) has remained a leading cause of maternal mortality for decades across the world and it results in critical obstetric complications. Recombinant activated factor VII (rFVIIa) has emerged as a gold standard adjunctive hemostatic agent for the treatment of life-threatening PPH refractory to conventional therapies although it remains off-licensed for use in PPH. We studied the effects of rFVIIa on coagulopathy, transfusion volume, prognosis, severity change in Korean PPH patients. METHODS: A retrospective review of medical records between December 2008 and March 2011 indicating use of rFVIIa in severe PPH was performed. We compared age, rFVIIa treatment, transfusion volume, and Sequential Organ Failure Assessment (SOFA) score at the time of arrival in the emergency department and after 24 hours for patients whose SOFA score was 8 points or higher. RESULTS: Fifteen women with SOFA score of 8 and above participated in this study and eight received rFVIIa administration whereas seven did not. Patients' mean age was 31.7 ± 7.5 years. There was no statistically significant difference in initial and post-24 hours SOFA scores between patients administered rFVIIa or not. The change in SOFA score between initial presentation and after 24 hours was significantly reduced after rFVIIa administration (P = 0.016). CONCLUSIONS: This analysis aimed to support that the administration of rFVIIa can reduce the severity of life-threatening PPH in patients. A rapid decision regarding the administration of rFVIIa is needed for a more favorable outcome in severe PPH patients for whom there is no effective standard treatment.
Emergency Service, Hospital ; Factor VIIa ; Female ; Humans ; Maternal Death ; Maternal Mortality ; Medical Records ; Organ Dysfunction Scores ; Postpartum Hemorrhage ; Postpartum Period ; Prognosis ; Recombinant Proteins ; Retrospective Studies

Diffuse alveolar hemorrhage (DAH) is a life-threatening pulmonary complication in patients with hematologic malignancies or autoimmune disorders. The current treatment options, which include corticosteroids, transfusions, extracorporeal membrane oxygenation (ECMO), and immunosuppressants, have been limited and largely unsuccessful. Recombinant activated factor VII (rFVIIa) has been successfully administered, either systemically or bronchoscopically, to adults for the treatment of DAH, but there are few data on its use in pediatric patients. The current literature in the PubMed database was reviewed to evaluate the efficacy and risk of rFVIIa treatment for DAH in pediatric patients. This review discusses the diagnosis and treatment of DAH, as well as a new treatment paradigm that includes rFVIIa. Additionally, the risks and benefits of off-label use of rFVIIa in pediatric patients are discussed.
Adrenal Cortex Hormones ; Adult ; Child ; Diagnosis ; Extracorporeal Membrane Oxygenation ; Factor VIIa* ; Hematologic Neoplasms ; Hemorrhage* ; Humans ; Immunosuppressive Agents ; Off-Label Use ; Risk Assessment

Diffuse alveolar hemorrhage (DAH) is a life-threatening pulmonary complication in patients with hematologic malignancies or autoimmune disorders. The current treatment options, which include corticosteroids, transfusions, extracorporeal membrane oxygenation (ECMO), and immunosuppressants, have been limited and largely unsuccessful. Recombinant activated factor VII (rFVIIa) has been successfully administered, either systemically or bronchoscopically, to adults for the treatment of DAH, but there are few data on its use in pediatric patients. The current literature in the PubMed database was reviewed to evaluate the efficacy and risk of rFVIIa treatment for DAH in pediatric patients. This review discusses the diagnosis and treatment of DAH, as well as a new treatment paradigm that includes rFVIIa. Additionally, the risks and benefits of off-label use of rFVIIa in pediatric patients are discussed.
Adrenal Cortex Hormones ; Adult ; Child ; Diagnosis ; Extracorporeal Membrane Oxygenation ; Factor VIIa* ; Hematologic Neoplasms ; Hemorrhage* ; Humans ; Immunosuppressive Agents ; Off-Label Use ; Risk Assessment

BACKGROUND: Pulmonary hemorrhage in prematurity is a life-threatening complication and associated with a high mortality. Recombinant activated factor VII (rFVIIa) has been reported as hemostatic treatment in sick neonates with refractory bleeding events in many studies. We evaluated the efficacy and safety of rFVIIa in prematurity with pulmonary hemorrhage in our institution.METHODS: From the prematurities who were treated with rFVIIa to pulmonary hemorrhage from January 2010 to December 2015, we retrospectively analyzed the results of rFVIIa.RESULTS: Of the 29 prematurities who were treated with rFVIIa for pulmonary hemorrhage, fifteen were male and fourteen were female. The median gestational age was 27 1/7 weeks (range, 22 1/7-34 1/7 weeks) and median birth weight was 870 g (range, 470-2,070 g). One to eight doses of rFVIIa (median dose 115.6 µg/kg/dose) were administered, with 16 (55%) patients receiving a single dose. Hemostatic effect was achieved in 21 (72.4%) cases, but 6 of 21 patients died of unrelated cause, and overall mortality was 14 of 29 (48.3%). Thrombotic adverse event was not observed in any of our patients.CONCLUSION: Although the number of patients included in this study was small and the fact that this was a retrospective non-randomized control study, rFVIIa could be considered as a therapeutic option for pulmonary hemorrhage in prematurity.
Birth Weight ; Factor VIIa ; Female ; Gestational Age ; Hemorrhage ; Humans ; Infant, Newborn ; Infant, Premature ; Male ; Mortality ; Retrospective Studies

Factor VIIa ; Hemorrhage ; Humans ; Leukemia, Promyelocytic, Acute ; Recombinant Proteins

Congenital factor VII deficiency is a rare hemorrhagic disorder, and invasive procedures are likely to cause excessive bleeding in these patients. Endoscopic submucosal dissection (ESD) has been accepted as a curative treatment modality for gastric adenoma, early gastric cancer (EGC) and any other mucosal and submucosal tumors. The most important complications of ESD are bleeding and perforation. The use of antiplatelet agents or coagulopathies are risk factors for these complications. There are only few reports of successful ESD with coagulation disorders. We report a case of a 70-year-old female patient who was diagnosed with a gastric adenoma and factor VII deficiency. The patient was successfully treated with ESD. Before ESD, recombinant Coagulation factor VIIa was injected, and the procedure was performed successfully without any complications. In conclusion, ESD can be performed successfully in patients with factor VII deficiency, when recombinant human factor VIIa is administered properly.
Adenoma* ; Aged ; Endoscopy ; Factor VII Deficiency* ; Factor VIIa ; Female ; Hemorrhage ; Hemorrhagic Disorders ; Humans ; Platelet Aggregation Inhibitors ; Risk Factors ; Stomach Neoplasms

Development of inhibitors is currently one of the most serious complications of hemophilia treatment. Typically, the propensity to develop an inhibitor is likely influenced by both genetic and non-genetic factors. Hemophilia patients with inhibitors are partially or completely refractory to traditional replacement of the deficient clotting factors and are at increased risk of bleeding as compared to patients without inhibitors. Several cases of infant hemophilia A with inhibitor have been reported in other countries, but no such patient has so far been reported in South Korea. We report two infants affected by hemophilia A with inhibitors, both of whom had bleeding episodes that were successfully treated with recombinant activated factor VII. Clinicians should remain aware of potential inhibitor development in infant hemophilia A patients and such patients should be carefully monitored.
Factor VIIa ; Hemophilia A ; Hemorrhage ; Humans ; Infant ; Korea

Recombinant activated factor VII (rFVIIa) is a novel therapeutic agent for life-threatening massive gastrointestinal bleeding. We report a case of massive gastrointestinal bleeding in a 78-year-old female patient with respiratory and renal failure. After failure of management of the bleeding with routine pharmacotherapy, we gave the patient rFVIIa injection at the dose of 20 µg/kg and the bleeding was rapidly controlled. Adverse side effects of the drug were not observed in this patient.
Aged ; Factor VIIa ; therapeutic use ; Female ; Gastrointestinal Hemorrhage ; drug therapy ; Humans ; Recombinant Proteins ; therapeutic use ; Renal Insufficiency ; Respiratory Insufficiency

Glanzmann's thrombasthenia (GT) is a rare autosomal recessive disease and platelet function disorder, in which platelet membrane GP IIb/ IIIa complex is defective and platelet aggregation is undeveloped. GT is characterized by mucocutaneous hemorrhages, such as, epistaxis, purpura, gingival bleeding, and menorrhagia, severe bleeding complications during surgery. We report the case of a 6-year-old boy with GT who underwent tonsillectomy. Here, we focus on perioperative hemostatic management using recombinant factor VIIa, fibrin glue and hemostat materials.
Blood Platelets ; Child ; Epistaxis ; Factor VIIa ; Female ; Fibrin Tissue Adhesive ; Hemorrhage ; Hemostasis ; Humans ; Male ; Membranes ; Menorrhagia ; Platelet Aggregation ; Purpura ; Thrombasthenia ; Tonsillectomy