A meta-analysis of the efficacy and safety of recombinant activated factor VII for patients with acute intracerebral hemorrhage without hemophilia

Yuan, Zhenting; Jiang, Jingxin; Huang, Weidong; Pan, Jianwei; Zhu, Jinhui; Wang, J.Z.

doi:10.1016/j.jocn.2009.11.020

Cited by 63 publications

(33 citation statements)

References 35 publications

(52 reference statements)

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“…This might be the main limitation of all the selected studies. Indeed, evidence from trials and related meta-analyses investigating recombinant factor VIIa in the setting of spontaneous ICH [29,30] showed that reducing or even stopping haematoma growth does not necessarily correspond to improving clinical outcome. Although such a result could be explained by inappropriate patient selection, it underlines the importance of identifying appropriate clinical outcomes to reflect expected effects of interventions.…”

Section: Discussionmentioning

confidence: 99%

Accuracy of the Spot Sign on Computed Tomography Angiography as a Predictor of Haematoma Enlargement after Acute Spontaneous Intracerebral Haemorrhage: A Systematic Review

Giudice

D'Amico²,

Sobesky

et al. 2014

Cerebrovasc Dis

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Background: A common early complication of intracerebral haemorrhage (ICH) is haematoma enlargement (HE), a strong independent predictor of a poor outcome. Therapeutic options to limit haematoma progression are currently scarce. Haemostatic therapy may be effective in patients with ICH, but it carries the risk of thromboembolic events in unselected patients. Accurate patient selection would, therefore, be of key importance for delivering potentially successful therapeutic strategies. Currently, there is no gold standard to accurately predict HE. The presence of contrast extravasation within the haematoma on computed tomography angiography (CTA), the ‘spot sign', has been reported in several studies and seems a particularly promising marker but lacks a standardised evaluation so far. Summary: We conducted a systematic review of published data to address the research question: In adults with acute spontaneous ICH, how accurately does the spot sign predict HE on follow-up imaging and thus poor functional outcome or mortality? We searched PubMed and Embase databases (from 1980 to May 2012), using a highly sensitive search strategy and including all studies involving adult patients with spontaneous ICH evaluated with CTA and follow-up CT scans, reporting any measure of clinical outcome, and reporting or allowing calculation of accuracy measures of the spot sign in predicting HE and clinical outcome. Baseline characteristics, accuracy measures and effect measures, as well as bias assessment, were reported according to PRISMA recommendations. The quality of the studies was appraised using an adapted version of the REMARK reporting recommendations. From 259 potentially relevant studies, we finally selected 6 studies (1 of them was a multicentre cohort study) covering a total of 709 patients. Studies varied substantially in terms of size, methodological quality, definitions of terms, outcomes selected and results. In particular, definition of the spot sign was not consistent in all studies. Furthermore, the only outcome measure consistently available was HE, while definitions and analyses of clinical outcomes seemed not adequate. Lastly, the choice of candidate variables for univariate and multivariate analyses did not include all determinants of HE and poor functional outcome. High heterogeneity was demonstrated (I²: 94% for HE) with substantial potential of bias. Key Messages: Studies of the spot sign are diverse and therefore complex to interpret. Our research question could not be answered due to heterogeneity and potential of bias in the selected studies. Further appropriately powered studies using standardised definitions and taking all predictors of HE and poor clinical outcome into account are required for a proper clinical implementation.

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Section: Discussionmentioning

confidence: 99%

Accuracy of the Spot Sign on Computed Tomography Angiography as a Predictor of Haematoma Enlargement after Acute Spontaneous Intracerebral Haemorrhage: A Systematic Review

Giudice

D'Amico²,

Sobesky

et al. 2014

Cerebrovasc Dis

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“…A meta-analysis of these and other randomized controlled trials concluded that, although rFVIIa could reduce hemorrhage progression in ICH, there is no significant improvement in mortality or function status and that it was associated with increased risk of thromboembolic events. 85 Note that patients on VKA were frequently excluded in rFVIIa trials mentioned earlier.…”

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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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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“…Several therapeutic measures to prevent hematoma expansion have been studied including aggressive blood pressure control, factor VII and surgery, some of which carry the risk of major adverse events with marginal if any treatment benefits [11][12][13]. Thus, it is important to tailor such therapies to a subgroup of ICH patients who are more likely to have hematoma expansion.…”

Section: Introductionmentioning

confidence: 99%

Hematoma expansion in spontaneous intracerebral hemorrhage: predictors and outcome

Yaghi

Dibu

Achi

et al. 2014

International Journal of Neuroscience

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A meta-analysis of the efficacy and safety of recombinant activated factor VII for patients with acute intracerebral hemorrhage without hemophilia

Cited by 63 publications

References 35 publications

Accuracy of the Spot Sign on Computed Tomography Angiography as a Predictor of Haematoma Enlargement after Acute Spontaneous Intracerebral Haemorrhage: A Systematic Review

Accuracy of the Spot Sign on Computed Tomography Angiography as a Predictor of Haematoma Enlargement after Acute Spontaneous Intracerebral Haemorrhage: A Systematic Review

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

Hematoma expansion in spontaneous intracerebral hemorrhage: predictors and outcome

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