Recombinant Activated Factor VII for Acute Intracerebral Hemorrhage

Mayer, Stephan A.; Brun, Nikolai C.; Begtrup, Kamilla; Broderick, Joseph P.; Davis, Stephen M.; Diringer, Michael N.; Skolnick, Brett E.; Steiner, Thorsten

doi:10.1056/nejmoa042991

Cited by 1,159 publications

(685 citation statements)

References 19 publications

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“…2,4 Significant hematoma growth, which was defined as hematoma growth >33% or 12.5 mL has been reported in approximately one third of ICH patients. 7,[9][10][11] Because early hematoma growth is associated with poor functional outcome, identification of potential predictors for hematoma growth is crucial for early diagnosis and management.…”

Section: Discussionmentioning

confidence: 99%

Blend Sign on Computed Tomography

Zhang

Huang

et al. 2015

Stroke

251

115

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Background and Purpose-Early hematoma growth is not uncommon in patients with intracerebral hemorrhage and is an independent predictor of poor functional outcome. The purpose of our study was to report and validate the use of our newly identified computed tomographic (CT) blend sign in predicting early hematoma growth. Methods-Patients with intracerebral hemorrhage who underwent baseline CT scan within 6 hours after onset of symptoms were included. The follow-up CT scan was performed within 24 hours after the baseline CT scan. Significant hematoma growth was defined as an increase in hematoma volume of >33% or an absolute increase of hematoma volume of >12.5 mL. The blend sign on admission nonenhanced CT was defined as blending of hypoattenuating area and hyperattenuating region with a well-defined margin. Univariate and multivariable logistic regression analyses were performed to assess the relationship between the presence of the blend sign on nonenhanced admission CT and early hematoma growth. Results-A total of 172 patients were included in our study. Blend sign was observed in 29 of 172 (16.9%) patients with intracerebral hemorrhage on baseline nonenhanced CT scan. Of the 61 patients with hematoma growth, 24 (39.3%) had blend sign on admission CT scan. Interobserver agreement for identifying blend sign was excellent between the 2 readers (κ=0.957). The multivariate logistic regression analysis demonstrated that the time to baseline CT scan, initial hematoma volume, and presence of blend sign on baseline CT scan to be independent predictors of early hematoma growth. The sensitivity, specificity, positive and negative predictive values of blend sign for predicting hematoma growth were 39.3%, 95.5%, 82.7%, and 74.1%, respectively. Conclusions-The CT blend sign could be easily identified on regular nonenhanced CT and is highly specific for predicting hematoma growth.

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Section: Discussionmentioning

confidence: 99%

Blend Sign on Computed Tomography

Zhang

Huang

et al. 2015

Stroke

251

115

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“…Improved ischemic stroke care is due to both the widespread use of specific therapies, such as thrombolysis, and to the management of ischemic stroke at stroke units. Only recently has a new therapeutic approach shown promising data in patients with ICH [24, 25] – the use of activated factor VII.…”

Section: Discussionmentioning

confidence: 99%

Effect of On-Admission Antiplatelet Treatment on Patients with Cerebral Hemorrhage

et al. 2007

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Background: Antiplatelet treatment remains the first choice for primary and secondary prevention of vascular diseases; even so, expected benefits may be offset by risk of bleeding, particularly cerebral hemorrhage. The aim of this study was to assess the influence of antiplatelet treatment on clinical outcome at hospital discharge. Materials and Methods: Consecutive patients with first-ever stroke due to a primary intraparenchymal hemorrhage were prospectively identified over a 4-year period (2000–2003). Data on hemorrhage location, vascular risk factors, and antiplatelet and anticoagulant treatment were collected. At discharge, outcome was measured using the modified Rankin Scale (disabling stroke ≧3). Patients treated with anticoagulant therapy were excluded from the study. Results: Of 457 consecutive patients with cerebral hemorrhage, 94 (20.5%) had been taking antiplatelet agents. The treated patients (mean age for antiplatelet group 78.9 ± 9.0 years) were older than the nontreated patients (73.8 ± 9.4, p = 0.02). In-hospital mortality was 23.4 and 23.1% (p = n.s.) for patients who had been taking antiplatelet agents or no treatment. Poor outcome at discharge was found in 52.1 and 59.7% (p = n.s.), respectively. Univariate analysis showed that age and coma at admission were predictors of disability at discharge, but antiplatelet treatment was not. Additionally, age and coma were shown to be determinants of disability at discharge after multivariate analysis: OR 1.03 per year (95% CI: 1.018–1.049), p < 0.001 and OR 1.68 (95% CI: 1.138–2.503), p = 0.009, respectively. Conclusions: Hemorrhagic stroke continues to be responsible for a high percentage of disability and death. Furthermore, it was seen here that functional outcome was independent of previous antiplatelet treatment.

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“…Although a phase 2 randomized trial showed that treatment with rFVIIa within 4 hours after ICH onset limited hematoma growth and improved clinical outcome relative to placebo, a subsequent phase 3 trial did not find clinical benefit. 108,109 Use of rFVIIa was associated with an increased frequency of thromboembolic events compared with placebo (7% versus 2%) in the phase 2 trial and significantly more arterial events in the phase 3 trial. It remains to be determined whether rFVIIa might benefit a particular subset of patients with ICH, but currently its benefits in ICH patients, whether or not they are taking an OAC, remain unproven.…”

Section: Antiplatelet Medication-related Ichmentioning

confidence: 99%

Guidelines for the Management of Spontaneous Intracerebral Hemorrhage

Hemphill¹,

Greenberg²,

Anderson³

et al. 2015

Stroke

2,949

1,196

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2032Purpose-The aim of this guideline is to present current and comprehensive recommendations for the diagnosis and treatment of spontaneous intracerebral hemorrhage. Methods-A formal literature search of PubMed was performed through the end of August 2013. The writing committee met by teleconference to discuss narrative text and recommendations. Recommendations follow the American Heart Association/American Stroke Association methods of classifying the level of certainty of the treatment effect and the class of evidence. Prerelease review of the draft guideline was performed by 6 expert peer reviewers and by the members of the Stroke Council Scientific Oversight Committee and Stroke Council Leadership Committee. Results-Evidence-based guidelines are presented for the care of patients with acute intracerebral hemorrhage. Topics focused on diagnosis, management of coagulopathy and blood pressure, prevention and control of secondary brain injury and intracranial pressure, the role of surgery, outcome prediction, rehabilitation, secondary prevention, and future considerations. Results of new phase 3 trials were incorporated. Conclusions-Intracerebral hemorrhage remains a serious condition for which early aggressive care is warranted.These guidelines provide a framework for goal-directed treatment of the patient with intracerebral hemorrhage.

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Recombinant Activated Factor VII for Acute Intracerebral Hemorrhage

Abstract: Treatment with rFVIIa within four hours after the onset of intracerebral hemorrhage limits the growth of the hematoma, reduces mortality, and improves functional outcomes at 90 days, despite a small increase in the frequency of thromboembolic adverse events.

Cited by 1,159 publications

References 19 publications

Blend Sign on Computed Tomography

Blend Sign on Computed Tomography

Effect of On-Admission Antiplatelet Treatment on Patients with Cerebral Hemorrhage

Guidelines for the Management of Spontaneous Intracerebral Hemorrhage

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