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Can a Subset of Intracerebral Hemorrhage Patients Benefit From Hemostatic Therapy With Recombinant Activated Factor VII

Published on Mar 1, 2009in Stroke6.058
· DOI :10.1161/STROKEAHA.108.524470
Stephan A. Mayer71
Estimated H-index: 71
,
Stephen M. Davis Mpa Msw94
Estimated H-index: 94
+ 5 AuthorsThorsten Steiner48
Estimated H-index: 48
Abstract
Background and Purpose— In the Factor Seven for Acute Hemorrhagic Stroke (FAST) trial, 80 μg/kg of recombinant activated factor VII (rFVIIa) significantly reduced intracerebral hemorrhage (ICH) expansion when given within 4 hours of onset. However, in contrast to an earlier Phase 2b study, rFVIIa did not improve survival or functional outcome. In this exploratory analysis, we hypothesized that earlier treatment and exclusion of patients with a poor prognosis at baseline might enhance the benefit of rFVIIa treatment. Methods— Using the FAST data set, the impact of rFVIIa (80 μg/kg) on poor outcome at 3 months (modified Rankin Score of 5 or 6) was systematically evaluated within subgroups using clinically meaningful cut points in onset-to-treatment time, age, and baseline ICH and intraventricular hemorrhage volume. The effect of treatment on outcome was analyzed using logistic regression, and ICH volume was analyzed with linear mixed models. Results— A subgroup (n=160, 19% of the FAST population) was identi...
  • References (28)
  • Citations (111)
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References28
Newest
#1Stephan A. Mayer (Columbia University)H-Index: 25
#2Nikolai C. BrunH-Index: 9
Last. Thorsten SteinerH-Index: 48
view all 8 authors...
Background Intracerebral hemorrhage is the least treatable form of stroke. We performed this phase 3 trial to confirm a previous study in which recombinant activated factor VII (rFVIIa) reduced growth of the hematoma and improved survival and functional outcomes. Methods We randomly assigned 841 patients with intracerebral hemorrhage to receive pla­ cebo (268 patients), 20 μg of rFVIIa per kilogram of body weight (276 patients), or 80 μg of rFVIIa per kilogram (297 patients) within 4 hours after...
845 CitationsSource
#1Michael N. DiringerH-Index: 57
#2Brett E. SkolnickH-Index: 16
Last. Joseph P. BroderickH-Index: 112
view all 7 authors...
Background and Purpose— Recombinant activated factor VII (rFVIIa) reduces hematoma expansion and improves outcome after intracerebral hemorrhage (ICH), with an apparent increase in nonfatal thromboembolic events (TEs) with higher doses. Despite low incidences of such events in rFVIIa-treated hemophiliacs, the frequency in older patients with more atherosclerosis and immobility has yet to be defined. Methods— Data were pooled from 3 randomized placebo-controlled studies in patients diagnosed with...
60 CitationsSource
#1J.J. KimH-Index: 2
#2Andrew C. SmithH-Index: 9
Last. Max WintermarkH-Index: 61
view all 7 authors...
BACKGROUND AND PURPOSE: Recent studies of intracerebral hemorrhage (ICH) treatments have highlighted the need to identify reliable predictors of hematoma expansion. The goal of this study was to determine whether contrast extravasation on multisection CT angiography (CTA) and/or contrast-enhanced CT (CECT) of the brain is associated with hematoma expansion and increased mortality in patients with primary ICH. MATERIALS AND METHODS: All patients with primary ICH who underwent CTA and CECT, as wel...
129 CitationsSource
#1Joseph P. Broderick (UC: University of Cincinnati)H-Index: 112
#2Sander ConnollyH-Index: 5
Last. Mario ZuccarelloH-Index: 44
view all 11 authors...
Purpose— The aim of this statement is to present current and comprehensive recommendations for the diagnosis and treatment of acute spontaneous intracerebral hemorrhage. Methods— A formal literature search of Medline was performed through the end date of August 2006. The results of this search were complemented by additional articles on related issues known to the writing committee. Data were synthesized with the use of evidence tables. The American Heart Association Stroke Council’s Levels of E...
615 CitationsSource
#1Eric JüttlerH-Index: 26
#2Stefan SchützeH-Index: 81
Last. Werner HackeH-Index: 114
view all 9 authors...
Background and Purpose— Decompressive surgery (hemicraniectomy) for life-threatening massive cerebral infarction represents a controversial issue in neurocritical care medicine. We report here the 30-day mortality and 6- and 12-month functional outcomes from the DESTINY trial. Methods— DESTINY (ISRCTN01258591) is a prospective, multicenter, randomized, controlled, clinical trial based on a sequential design that used mortality after 30 days as the first end point. When this end point was reached...
525 CitationsSource
#1Joseph P. BroderickH-Index: 112
#2Sander ConnollyH-Index: 5
Last. Mario ZuccarelloH-Index: 44
view all 11 authors...
Purpose— The aim of this statement is to present current and comprehensive recommendations for the diagnosis and treatment of acute spontaneous intracerebral hemorrhage. Methods— A formal literature search of Medline was performed through the end date of August 2006. The results of this search were complemented by additional articles on related issues known to the writing committee. Data were synthesized with the use of evidence tables. The American Heart Association Stroke Council’s Levels of E...
627 CitationsSource
#2Erwin ChiqueteH-Index: 13
view all 5 authors...
Background and Purpose— This study aimed to independently derive an intracerebral hemorrhage grading scale (ICH-GS) for prediction of 3 outcome measures. Methods— We evaluated 378 patients with primary ICH at hospital arrival and during the next 30 days. Independent predictors were identified by multivariate models of in-hospital and 30-day mortality. Points were allotted to each predictor based on its prognostic performance. ICH-GS was also evaluated to predict good 30-day functional status and...
131 CitationsSource
#1Richard B. Welskopf (UCSF: University of California, San Francisco)H-Index: 51
Recombinant activated coagulation factor VII (rFVIIa) was developed initially for treatment of patients with hemophilia and neutralizing antibodies (“inhibitors”) to coagulation factors VIII or IX. Owing to the unique and selective mechanism of action of rFVIIa and encouraged by clinical experience with other circumstances of inadequate hemostasis, a broad development program has been pursued to test potential efficacy and evaluate safety of this biologic for indications other than hemophilia. T...
19 CitationsSource
#1Joshua N. GoldsteinH-Index: 41
#2L. E. FazenH-Index: 3
Last. Jonathan RosandH-Index: 70
view all 8 authors...
Background: Patients with acute intracerebral hemorrhage (ICH) presenting within 3 hours of symptom onset are known to be at increased risk of expansion. However, only a minority arrive within this time frame. Therefore, alternative markers for expansion risk are needed. Objective: To examine whether contrast extravasation on CT angiography (CTA) at presentation predicts subsequent hematoma expansion. Methods: Consecutive patients with primary ICH presenting to an urban tertiary care hospital we...
202 CitationsSource
#1Stephan A. Mayer (CUMC: Columbia University Medical Center)H-Index: 25
background Intracerebral hemorrhage is the least treatable form of stroke and is associated with high mortality. Among patients who undergo computed tomography (CT) within three hours after the onset of intracerebral hemorrhage, one third have an increase in the volume of the hematoma related to subsequent bleeding. We sought to determine whether recombinant activated factor VII (rFVIIa) can reduce hematoma growth after intracerebral hemorrhage. methods We randomly assigned 399 patients with int...
944 CitationsSource
Cited By111
Newest
#1Bin Cai (Peking Union Medical College Hospital)
#2Lin Peng (University of Bonn)
Last. Bin Peng (Peking Union Medical College Hospital)H-Index: 13
view all 5 authors...
Abstract Objectives: Although several studies have shown that interventions to lower blood lipid concentration may reduce the risk of coronary arterial disease and ischemic stroke, the correlation between serum lipid levels and hemorrhagic stroke remains controversial. To clarify any possible association between serum lipid and hematoma expansion, we examined various serum lipid indices in patients with and without early hematoma expansion. Methods: Data of 572 intracerebral hemorrhage (ICH) pat...
Source
#1Andrew N Hall (NU: Northwestern University)H-Index: 1
#2Bradley Weaver (NU: Northwestern University)
Last. Andrew M. Naidech (NU: Northwestern University)H-Index: 33
view all 7 authors...
BACKGROUND/OBJECTIVE: Demonstrating a benefit of acute treatment to patients with intracerebral hemorrhage (ICH) requires identifying which patients have a potentially modifiable outcome, where treatment could favorably shift a patient's expected outcome. A decision rule for which patients have a modifiable outcome could improve the targeting of treatments. We sought to determine which patients with ICH have a modifiable outcome. METHODS: Patients with ICH were prospectively identified at two in...
Source
#1Christine Lodberg Hvas (Aarhus University Hospital)H-Index: 4
#2Signe Voigt Lauridsen (Aarhus University Hospital)H-Index: 2
Last. Anne-Mette Hvas (AU: Aarhus University)H-Index: 8
view all 5 authors...
Abstract Background Rebleeding and hematoma growth are serious complications in subarachnoid hemorrhage (SAH) and intracerebral hemorrhage (ICH). As treatment options are sparse, a mechanistic approach may reveal new therapeutic targets. Aim Firstly, to evaluate hemostasis using a sensitive low tissue factor thromboelastometry (ROTEM®) assay in patients with SAH or ICH and compare them with healthy controls. Secondly, to investigate the ex vivo effect of hemostatic or antifibrinolytic medication...
Source
#1Audrey C Leasure (Yale University)H-Index: 6
#2Adnan I. QureshiH-Index: 57
Last. Guido J. Falcone (Yale University)H-Index: 23
view all 13 authors...
Importance Hypertension is the strongest risk factor for spontaneous intracerebral hemorrhage (ICH) involving deep brain regions, but it appears to be unknown if intensive blood pressure reduction in the acute care setting decreases hematoma expansion or improves outcomes in patients with deep ICH. Objective To determine whether intensive blood pressure reduction is associated with decreased risk of hematoma expansion and changes in 90-day modified Rankin Scale scores and if these associations a...
1 CitationsSource
#1Qiuguang He (CQMU: Chongqing Medical University)
#2You Zhou (CQMU: Chongqing Medical University)
Last. Zongyi Xie (CQMU: Chongqing Medical University)H-Index: 4
view all 6 authors...
Abstract Background: Hematoma expansion after acute spontaneous intracerebral hemorrhage (ICH) is well established to result in poor prognosis. Recent studies have demonstrated that the ABO blood type system has potential implications on hemostatic properties. The purpose of this study was to explore the potential association of blood type O with hematoma expansion in patients with ICH and validate the usefulness in predicting early hematoma expansion. Methods: We retrospectively enrolled consec...
Source
#1Ranier Reyes (UTSW: University of Texas Southwestern Medical Center)
#2Meera Viswanathan (UTSW: University of Texas Southwestern Medical Center)
Last. Venkatesh Aiyagari (UTSW: University of Texas Southwestern Medical Center)H-Index: 20
view all 3 authors...
ABSTRACTIntroduction: Intracerebral hemorrhage remains one of the leading causes of death and disability worldwide with few established interventions that improve neurologic outcome. Research dedic...
Source
#1P. Irimia Sieira (University of Navarra)H-Index: 1
#2I. Esparragosa (University of Navarra)
Last. Eduardo Martínez-Vila (University of Navarra)H-Index: 25
view all 4 authors...
Resumen La hemorragia intracerebral (HIC) representa un 20% de todos los ictus, y se produce por la extravasacion de sangre dentro del parenquima encefalico, producida por la ruptura de un vaso sanguineo. Las causas mas frecuentes son las denominadas primarias, en las que la pared de los vasos se debilita por la hipertension art erial cronica o por causas degenerativas como la angiopatia amiloide. Las causas secundarias incluyen las malformaciones vasculares, tumores o hemorragias inducidas por ...
Source
#1Charlotte Cordonnier (university of lille)H-Index: 35
#2Andrew M. Demchuk (U of C: University of Calgary)H-Index: 63
Last. Craig S. Anderson (PKU: Peking University)H-Index: 80
view all 4 authors...
Summary Acute spontaneous intracerebral haemorrhage is a life-threatening illness of global importance, with a poor prognosis and few proven treatments. As a heterogeneous disease, certain clinical and imaging features help identify the cause, prognosis, and how to manage the disease. Survival and recovery from intracerebral haemorrhage are related to the site, mass effect, and intracranial pressure from the underlying haematoma, and by subsequent cerebral oedema from perihaematomal neurotoxicit...
32 CitationsSource
#1Jun Zheng (Sichuan University)H-Index: 7
#2Zhiyuan Yu (Sichuan University)H-Index: 5
Last. Lu Ma (Sichuan University)H-Index: 7
view all 6 authors...
Objective Hematoma expansion is related to unfavorable prognosis in intracerebral hemorrhage (ICH). The black hole sign is a novel marker on non–contrast computed tomography for predicting hematoma expansion. However, its predictive values are different in previous studies. Thus, this meta-analysis was conducted to evaluate the predictive significance of the black hole sign for hematoma expansion in ICH. Methods A systematic literature search was performed. Original researches on the association...
3 CitationsSource
#1Christian Ovesen (Copenhagen University Hospital)H-Index: 5
#2Janus Christian Jakobsen (Copenhagen University Hospital)H-Index: 17
Last. Helen Christensen (Copenhagen University Hospital)H-Index: 103
view all 10 authors...
Objective We present the statistical analysis plan of a prespecified Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 sub-study aiming to investigate, if tranexamic acid has a different effect in intracerebral haemorrhage patients with the spot sign on admission compared to spot sign negative patients. The TICH-2 trial recruited above 2000 participants with intracerebral haemorrhage arriving in hospital within 8 h after symptom onset. They were included irrespective of r...
1 CitationsSource