Use of Recombinant Factor VIIa in Patients With Warfarin-Associated Intracranial Hemorrhage

Brody, David L.; Aiyagari, Venkatesh; Shackleford, Angela M.; Diringer, Michael N.

doi:10.1385/ncc:2:3:263

Cited by 132 publications

(87 citation statements)

References 18 publications

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“…74,75 Early reports of the off-label use of rFVIIa from one of our institutions as well as others on the successful management of warfarinassociated ICH with rFVIIa therapy led to the development of single-institution policies for oversight of its off-label use. [76][77][78][79][80] The value of rFVIIa in patients with spontaneous ICH who were not on warfarin anticoagulation underwent scrutiny in clinical trials in which it was shown to reduce growth of hematoma if administered within 4 hours of onset, 81 but it did not improve survival or functional outcome. 82 A subsequent post hoc analysis of these trials suggested that the use of rFVIIa was most beneficial and associated with improved outcomes in patients Յ 70 years old who had lower baseline hemorrhage volume and shorter time from onset to treatment.…”

Section: Prothrombin Complex Concentratesmentioning

confidence: 99%

“…Finally, 2 case series of patients with ICH who received rFVIIa for normalization of INR also had subgroups of patients who underwent neurosurgical procedures with adequate hemostasis. 76,97 Recently, Nishijima et al 98 studied 40 patients receiving warfarin who were admitted to the ED for traumatic ICH and reported that administration of rFVIIA was associated with shorter time to normal INR; however, there was no difference in mortality (or in thromboembolic complications) among patients who received rFVIIA and patients who did not.…”

Section: Prothrombin Complex Concentratesmentioning

confidence: 99%

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How I treat warfarin-associated coagulopathy in patients with intracerebral hemorrhage

Goodnough

Shander

2011

Blood

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Intracerebral hemorrhage in patients with warfarin-associated coagulopathy is an increasingly common life-threatening condition that requires emergent management. The evolution of therapeutic options in this setting, as well as recently published guidelines, has resulted in some heterogeneity in recommendations by professional societies. This heterogeneity can be attributed to lack of evidencebased support for plasma therapy; the variability in availability of prothrombin complex concentrates; the variability in the coagulation factor levels and contents of prothrombin complex concentrates; ambiguity about the optimal dose and route of administration of vitamin K; and the lack of standardized clinical care pathways, particularly in community hospitals, for the management of these critical care patients. In this review, we summarize the relevant literature about these controversies and present recommendations for management of patients with warfarin-associated coagulopathy and intracerebral hemorrhage.(Blood. 2011; 117(23):6091-6099)

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Section: Prothrombin Complex Concentratesmentioning

confidence: 99%

Section: Prothrombin Complex Concentratesmentioning

confidence: 99%

How I treat warfarin-associated coagulopathy in patients with intracerebral hemorrhage

Goodnough

Shander

2011

Blood

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“…30 -32 A recent review of 12 patients with acute warfarinassociated ICH over this same time period at one institution, all of whom received rFVIIa (30 -135 g/kg) as well as vitamin K (10 mg/day for 3 days) and fresh-frozen plasma (1307 Ϯ 652 mL) for treatment, found that treatment was associated with rapid correction of INR, and that single doses appeared safe in this high-risk population. 32 These observations indicate that rFVIIa may be used to reverse the effect of warfarin or other vitamin K-antagonist therapy in cases in which the administration of vitamin K alone has been found to be insufficient. In contrast, the risk of TAEs observed in clinical trials evaluating off-label uses of rFVIIa has raised concerns.…”

Section: Rfviia Use In Spontaneous Ichmentioning

confidence: 99%

Recombinant Factor VIIa: An Assessment of Evidence Regarding Its Efficacy and Safety in the Off-Label Setting

Logan

Goodnough

2010

Hematology

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Recombinant human factor VIIa (rFVIIa) is approved by the US Food and Drug Administration for use in the setting of hemorrhage associated with factor VIII or factor IX inhibitors in patients with congenital or acquired hemophilia. This indication represents only a small number of bleeding conditions. Since it became available, rFVIIa has been increasingly used in the management of off-label indications, ranging from emergent hemostasis in traumatic hemorrhage to prophylactic hemostasis in patients undergoing major surgery. Prominent off-label indications include the management of patients with coagulopathies, such as occurs in trauma patients experiencing massive and uncontrolled hemorrhage, and in patients undergoing cardiovascular surgery with cardiopulmonary bypass. Other occasions for use occur in patients with intact coagulation systems, with nontraumatic intracranial hemorrhage being the most common in this group. Uncertainties regarding the efficacy and safety associated with use of rFVIIa in these off-label scenarios have led to evidence-based assessments of patient outcomes, including mortality, the rate of thromboembolic adverse events, and posttreatment functional status. We review the evidence regarding the efficacy and safety of this important, but controversial, hemostatic agent in the off-label setting.

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“…The ability of rFVIIa to effect hemostasis in other clinical settings has also been demonstrated in case reports and clinical trials. [23][24][25][26] In a randomized, controlled trial investigating the safety and efficacy of rFVIIa in patients with upper gastrointestinal bleeding (UGIB) and cirrhosis, there was no significant effect of rFVIIa treatment on the number of 5-day failures in the total population. 8 However, a finding from posthoc analysis was that rFVIIa significantly reduced the number of 5-day failures and improved 24-hour bleeding control in the subgroup of Child-Pugh B and C patients with variceal bleeding, which were the patients with greater impairment of hemostatic parameters.…”

mentioning

confidence: 99%

Recombinant factor VIIa for variceal bleeding in patients with advanced cirrhosis: A randomized, controlled trial

et al. 2008

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on behalf of the International Study Group on rFVIIa in UGI Hemorrhage A beneficial effect of recombinant activated factor VII (rFVIIa) in Child-Pugh class B and C patients with cirrhosis who have variceal bleeding has been suggested. This randomized controlled trial assessed the efficacy and safety of rFVIIa in patients with advanced cirrhosis and active variceal bleeding. At 31 hospitals in an emergency setting, 256 patients (Child-Pugh > 8; Child-Pugh B ‫؍‬ 26%, C ‫؍‬ 74%) were randomized equally to: placebo; 600 g/kg rFVIIa (200 ؉ 4؋ 100 g/kg); or 300 g/kg rFVIIa (200 ؉ 100 g/kg). Dosing was intravenous at 0, 2, 8, 14, and 20 hours after endoscopy, in addition to standard vasoactive, prophylactic antibiotic, and endoscopic treatment. The primary composite endpoint consisted of failure to control 24-hour bleeding, or failure to prevent rebleeding or death at day 5. Secondary endpoints included adverse events and 42-day mortality. Baseline characteristics were comparable between groups. Administration of rFVIIa had no significant effect on the composite endpoint compared with placebo (P ‫؍‬ 0.37). There was no significant difference in 5-day mortality between groups; however, 42-day mortality was significantly lower with 600 g/kg rFVIIa compared with placebo (odds ratio 0.31, 95% confidence interval ‫؍‬ 0.13-0.74), and bleeding-related deaths were reduced from 12% (placebo) to 2% (600 g/kg). A marked heterogeneity in the failure rate in all treatment groups was observed across participating centers. Adverse events, including overall thromboembolic events, were comparable between groups. Conclusion: Treatment with rFVIIa had no significant effect on the primary composite endpoint compared with placebo. Therefore, decision on the use of this hemostatic agent in acute variceal bleeding should be carefully considered, because results of this study do not support the routine use of rFVIIa in this setting. Adverse events were comparable across groups. (HEPATOLOGY 2008;47:1604-1614

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Use of Recombinant Factor VIIa in Patients With Warfarin-Associated Intracranial Hemorrhage

Cited by 132 publications

References 18 publications

How I treat warfarin-associated coagulopathy in patients with intracerebral hemorrhage

How I treat warfarin-associated coagulopathy in patients with intracerebral hemorrhage

Recombinant Factor VIIa: An Assessment of Evidence Regarding Its Efficacy and Safety in the Off-Label Setting

Recombinant factor VIIa for variceal bleeding in patients with advanced cirrhosis: A randomized, controlled trial

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