***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
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    Input: BACKGROUND & AIMS Upper gastrointestinal bleeding ( UGIB ) is a severe and frequent complication of cirrhosis . Recombinant coagulation factor VIIa ( rFVIIa ) has been shown to correct the prolonged prothrombin time in patients with cirrhosis and UGIB . This trial aim ed to determine efficacy and safety of rFVIIa in cirrhotic patients with variceal and nonvariceal UGIB . METHODS A total of 245 cirrhotic patients ( Child-Pugh < 13 ; Child-Pugh A = 20 % , B = 52 % , C = 28 % ) with UGIB ( variceal = 66 % , nonvariceal = 29 % , bleeding source unknown = 5 % ) were r and omized equally to receive 8 doses of 100 microg/kg rFVIIa or placebo in addition to pharmacologic and endoscopic treatment . The primary end point was a composite including : ( 1 ) failure to control UGIB within 24 hours after first dose , or ( 2 ) failure to prevent rebleeding between 24 hours and day 5 , or ( 3 ) death within 5 days . RESULTS Baseline characteristics were similar between rFVIIa and placebo groups . rFVIIa showed no advantage over st and ard treatment in the whole trial population . Exploratory analyses , however , showed that rFVIIa significantly decreased the number of failures on the composite end point ( P = 0.03 ) and the 24-hour bleeding control end point ( P = 0.01 ) in the subgroup of Child-Pugh B and C variceal bleeders . There were no significant differences between rFVIIa and placebo groups in mortality ( 5- or 42-day ) or incidence of adverse events including thromboembolic events . CONCLUSIONS Although no overall effect of rFVIIa was observed , exploratory analyses in Child-Pugh B and C cirrhotic patients indicated that administration of rFVIIa significantly decreased the proportion of patients who failed to control variceal bleeding . Dosing with rFVIIa appeared safe . Further studies are needed to verify these findings Background — Blood loss is a common complication of cardiac surgery . Evidence suggests that recombinant activated factor VII ( rFVIIa ) can decrease intractable bleeding in patients after cardiac surgery . Our objective was to investigate the safety and possible benefits of rFVIIa in patients who bleed after cardiac surgery . Methods and Results — In this phase II dose-escalation study , patients who had undergone cardiac surgery and were bleeding were r and omized to receive  placebo ( n=68 ) , 40 & mgr;g/kg rFVIIa ( n=35 ) , or 80 & mgr;g/kg rFVIIa ( n=69 ) . The primary end points were the number of patients suffering critical serious adverse events . Secondary end points included rates of reoperation , amount of blood loss , and transfusion of allogeneic blood . There were more critical serious adverse events in the rFVIIa groups . These differences did not reach statistical significance ( placebo , 7 % ; 40 & mgr;g/kg , 14 % ; P=0.25 ; 80 & mgr;g/kg , 12 % ; P=0.43 ) . After r and omization , significantly fewer patients in the rFVIIa group underwent a reoperation as a result of bleeding ( P=0.03 ) or required allogeneic transfusions ( P=0.01 ) . Conclusions — On the basis of this preliminary evidence , rFVIIa may be beneficial for treating bleeding after cardiac surgery , but caution should be applied and further clinical trials are required because there is an increase in the number of critical serious adverse events , including stroke , in those patients r and omized to receive rFVIIa BACKGROUND Coagulopathy caused by cirrhosis may contribute to excessive bleeding during hepatectomy . We evaluated the hemostatic effect and safety of recombinant factor VIIa ( rFVIIa ) in cirrhotic patients undergoing partial hepatectomy . METHODS Patients were r and omized to rFVIIa 50 or 100 mug/kg or placebo , administered intravenously 10 minutes before surgery and every second hour during surgery . The primary efficacy end points were the proportion of patients receiving red blood cell ( RBC ) transfusions and the amount of RBCs transfused . The RBC transfusion trigger was blood loss of 500 mL. Safety end points included thromboembolic and adverse events . RESULTS No statistically significant effect of rFVIIa treatment on efficacy end points was observed . Serious and thromboembolic adverse events occurred at similar incidences in the study groups . CONCLUSIONS Using blood loss as a transfusion trigger , the efficacy of rFVIIa in reducing the requirement for RBC transfusion was not established in this study . No safety concerns were identified Patients undergoing orthotopic liver transplantation ( OLT ) have excessive blood loss during surgery that requires blood transfusions , leading to increased postoperative morbidity and mortality . We studied the efficacy and safety of activated recombinant factor VII ( rFVIIa ) in reducing transfusion requirements in OLT . This multicenter , r and omized , double-blind , placebo-controlled trial enrolled patients undergoing OLT because of cirrhosis ( Child-Turcotte-Pugh class B or C ) . Patients received a repeated intravenous bolus regimen of rFVIIa 60 or 120 microg/kg or placebo . The primary efficacy endpoint was the total number of red blood cell ( RBC ) units transfused during the perioperative period . A total of 182 patients were analyzed for efficacy and 183 for safety . No significant effect of rFVIIa was observed on the number of RBC units transfused or intraoperative blood loss compared with the placebo group . A significantly higher number of patients in the rFVIIa study groups avoided RBC transfusion . Administration of rFVIIa but not placebo restored the preoperative prolonged prothrombin time to normal value during surgery . Patients receiving rFVIIa and placebo did not experience a significant difference in rate of thromboembolic events . Additionally , there was no statistically significant effect of rFVIIa treatment on hospitalization rate , total surgery time , and the proportion of patients undergoing retransplantation . In conclusion , use of rFVIIa during OLT significantly reduced the number of patients requiring RBC transfusion . There was no increase in thromboembolic events with rFVIIa administration compared with placebo Background and Purpose — Hematoma growth occurs in 38 % of intracerebral hemorrhage ( ICH ) patients scanned by computed tomography ( CT ) within 3 hours of onset . Activated recombinant factor VII ( rFVIIa ) promotes hemostasis at sites of vascular injury and may minimize hematoma growth after ICH . Methods — In this r and omized , double-blind , placebo-controlled , dose-escalation trial , 48 subjects with ICH diagnosed within 3 hours of onset were treated with placebo ( n=12 ) or rFVIIa ( 10 , 20 , 40 , 80 , 120 , or 160 & mgr;g/kg ; n=6 per group ) . The primary endpoint was the frequency of adverse events ( AEs ) . Safety assessment s included serial electrocardiography ( ECG ) , troponin I and coagulation testing , lower extremity Doppler ultrasonography , and calculation of edema : ICH volume ratios . Results — Mean age was 61 years ( range , 30 to 93 ) and 57 % were male . At admission , mean National Institutes of Health Stroke Scale ( NIHSS ) score was 14 ( range , 1 to 26 ) , median Glasgow Coma Scale score was 14 ( range , 6 to 15 ) , and mean ICH volume was 21 mL ( range , 1 to 151 ) . Mean time from onset to treatment was 181 minutes ( range , 120 to 265 ) . Twelve serious AEs occurred , including 5 deaths ( mortality 11 % ) . Six AEs were considered possibly treatment-related , including rash , vomiting , fever , ECG T-wave inversion , and 2 cases of deep vein thrombosis ( placebo and 20-&mgr;g/kg groups ) . No myocardial ischemia , consumption coagulopathy , or dose-related increase in edema : ICH volume occurred . Conclusion — This small phase II trial evaluated a wide range of rFVIIa doses in acute ICH and raised no major safety concerns . Larger studies are justified to determine whether rFVIIa can safely and effectively limit ICH growth BACKGROUND Activated recombinant coagulation factor VII ( rFVIIa ) effectively prevents and controls bleeding in patients with coagulopathy . Data show that rFVIIa may reduce blood loss and eliminate the need for transfusion in patients with normal haemostasis undergoing major surgery . We assessed the efficacy of rFVIIa in patients with normal haemostasis undergoing repair surgery of major traumatic fracture of the pelvis or the pelvis and acetabulum , who were expected to have a large volume of blood loss . METHODS We performed a double-blind , r and omized , placebo-controlled trial involving 48 patients undergoing major pelvic-acetabular surgery . Patients were r and omized to receive an i.v . bolus injection of rFVIIa 90 microg kg(-1 ) or placebo as add-on therapy at the time of the first skin incision . All patients also received intraoperative salvaged red blood cells ( RBC ) . RESULTS There was no significant difference in the total volume of perioperative blood loss , the primary outcome variable , between the rFVIIa and placebo groups . In addition , there were no differences between the two groups in the total volume of blood components , including salvaged RBC transfused , number of patients requiring allogeneic blood components , total volume of fluids infused , total operating time , time taken after entry to the intensive care unit to reach normal body temperature and acid-base status , and time spent in hospital . No adverse events , in particular thromboembolic events , were reported in either group . CONCLUSIONS In patients with normal haemostasis undergoing repair surgery of traumatic pelvic-acetabular fracture , the prophylactic use of rFVIIa does not decrease the volume of perioperative blood loss Orthotopic liver transplantation ( OLT ) can be associated with excessive blood loss . As a result , there may be increased risk of adverse outcomes . Activated recombinant factor VII ( rFVIIa ) has demonstrated the ability to improve hemostasis in a variety of disorders ; however , there has been a limited amount of research into its use in OLT . The purpose of this dose-finding study was to examine the efficacy and safety of rFVIIa in the reduction of bleeding in patients undergoing OLT . In this double-blind trial , patients with end-stage liver disease scheduled for OLT were r and omized to 1 of 4 parallel study groups . They received a single intravenous bolus of rFVIIa ( 20 , 40 , or 80 microg/kg ) or placebo prior to surgery . The primary assessment endpoint was the total number of red blood cell ( RBC ) units transfused perioperatively . Safety was evaluated by adverse events reported . Eighty-three comparable patients were r and omized to receive study product , with 82 ultimately undergoing OLT . There were no significant differences in required RBC units between the placebo and rFVIIa study groups . The number of adverse events was comparable between study groups . In conclusion , rFVIIa has a good safety profile in patients undergoing OLT . However , the doses studied did not have any effect on the number of RBC transfusions required BACKGROUND Recombinant activated factor VII ( factor VIIa ) has prohaemostatic effects in bleeding patients with coagulation abnormalities . We aim ed to test the hypothesis that recombinant factor VIIa could reduce perioperative blood loss in patients with normal coagulation systems . Therefore , we assessed safety and efficacy of this drug in patients undergoing retropubic prostatectomy , which is often associated with major blood loss and need for transfusion .  METHODS In a double-blind , r and omised placebo-controlled trial , we recorded blood loss and transfusion requirements in 36 patients undergoing retropubic prostatectomy , who were r and omised to receive an intravenous bolus of recombinant factor VIIa ( 20 microg/kg or 40 microg/kg ) or placebo in the early operative phase . FINDINGS Median perioperative blood loss was 1235 mL ( IQR 1025 - 1407 ) and 1089 mL ( 928 - 1320 ) in groups given recombinant factor VIIa 20 microg/kg and 40 microg/kg , respectively , compared with 2688 mL ( 1707 - 3565 ) in the placebo group ( p=0.001 ) . Seven of twelve placebo-treated patients were transfused , whereas no patients who received 40 microg/kg recombinant factor VIIa needed transfusion . The odds ratio for receiving any blood product in patients treated with recombinant factor VIIa compared with control patients was 0 ( 95 % CI 0.00 - 0.33 ) No adverse events arose . INTERPRETATION An injection of recombinant factor VIIa can reduce perioperative blood loss and eliminate the need for transfusion in patients undergoing major surgery BACKGROUND & AIMS Activated recombinant factor VII ( rFVIIa ) has been shown to be effective in correcting prolonged prothrombin time ( PT ) in cirrhotic patients . The main objective of this study 
    Output:
    
INTERPRETATION Clinical ly significant benefits of recombinant factor VIIa as a general hemostatic agent in patients without hemophilia remain unproven .