Abstract WP356: Eligibility Criteria in Clinical Trials on Intracerebral Hemorrhage Applied to an Unselected Cohort: The Lund Stroke Register

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Björn M Hansen ◽  
Natalie Ullman ◽  
Bo Norrving ◽  
Daniel F Hanley ◽  
Arne Lindgren
Keyword(s):  
Intracerebral Hemorrhage ◽  
Functional Outcome ◽  
Therapeutic Benefit ◽  
Inclusion Criteria ◽  
Poor Functional Outcome ◽  
Eligibility Criteria ◽  
Survival Status ◽  
Lower Baseline ◽  
Unselected Cohort ◽  
Stroke Register

Introduction: Strict patient selection in medical or surgical trials on intracerebral hemorrhage (ICH) is needed to optimize therapeutic benefit but limits trial enrolment as well as overall applicability of results. We studied the applicability of previous, current, and planned large interventional ICH trials by applying each trial’s defined inclusion criteria to an unselected cohort of ICH patients. Methods: Large interventional ICH trials were identified via trial registration databases. To estimate eligibility rates, each trial’s inclusion criteria were applied on an unselected consecutive group of first-ever ICH patients from the prospective hospital-based Lund Stroke Register. Subsequently, 30 day survival status was obtained from the National Census Office and 90 day poor functional outcome (modified Rankin Scale ≥4 or death) from the Swedish Stroke Register or medical files. Results: Among 253 included ICH patients, estimated eligibility rates ranged from 2-38% for the identified 11 large interventional ICH trials (Figure 1). Patients not eligible for any of the trials (N=91, 36%) had: more extensive intraventricular hemorrhage (p<0.001); lower baseline level of consciousness (p<0.001); higher rate of cerebellar ICH and lower rates of lobar ICH (p<0.001). No significant age, sex, or ICH volume differences were observed. The 30 day mortality rates among eligible patients were 0-33% depending on selected trial. The mortality rate for patients not eligible for any trial was 55% vs 19% for patients eligible in ≥1 trial (95% CI: 45-65% vs 13-25%; p<0.001). Non-eligible ICH patients more frequently had poor functional outcome (75% vs 49%; 95% CI: 65-85% vs 41-57%; p<0.001). Conclusions: There is great variation in proportions of unselected ICH patients eligible for inclusion in treatment trials. Even in trials with broad entry criteria only a minority is eligible, which need to be considered when translating ICH-trial results into clinical practice.

scholarly journals Intraventricular Extension of Supratentorial Intracerebral Hemorrhage: The Modified Graeb Scale Improves Outcome Prediction in Lund Stroke Register

2015 ◽  
Vol 46 (1) ◽  
pp. 43-50 ◽  
Author(s):  
Björn M. Hansen ◽  
Timothy C. Morgan ◽  
Joshua F. Betz ◽  
Pia C. Sundgren ◽  
Bo Norrving ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Functional Outcome ◽  
Outcome Prediction ◽  
Characteristic Analysis ◽  
Poor Functional Outcome ◽  
Survival Status ◽  
Prognostic Accuracy ◽  
Unselected Population ◽  
Stroke Register

Background/Aims: The modified Graeb Scale (mGS) is a semi-quantitative method to assess the extension of intraventricular hemorrhage (IVH) in patients with intracerebral hemorrhage (ICH). The mGS has been shown to prognosticate outcome after ICH in cohorts derived from convenience samples. We evaluated the external validity of mGS in supratentorial ICH-patients from an unselected cohort. Methods: ICH-patients were included prospectively and consecutively in Lund Stroke Register. Follow-up survival status was obtained from the National Census Office; functional outcome was obtained from the Swedish Stroke Register or medical records. Using multivariate analyses, we examined if mGS was related to 30-day survival or poor functional outcome (modified Rankin Scale ≥4) at 90 days. Results: Of 198 supratentorial ICH-patients, 86 (43%) had IVH (median mGS 12, range 1-28). In multivariate regression analyses, the mGS independently predicted 30-day mortality (per point; OR 1.16; 95% CI 1.06-1.27; p = 0.002) and poor functional outcome (OR 1.11; 95% CI 1.02-1.20; p = 0.011) after ICH. In receiver-operator characteristic analysis, the addition of mGS tended to be associated with a higher prognostic accuracy for survival (area under curve 0.886 vs. not including mGS 0.812; p = 0.053). Conclusions: The mGS improves outcome prediction after supratentorial ICH beyond other previously established factors in an unselected population.

scholarly journals Contrast extravasation and outcome of endovascular therapy in acute ischaemic stroke: a systematic review and meta-analysis

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e044917
Author(s):  
Tao Xu ◽  
You Wang ◽  
Jinxian Yuan ◽  
Yangmei Chen ◽  
Haiyan Luo
Keyword(s):  
Systematic Review ◽  
Ischaemic Stroke ◽  
Functional Outcome ◽  
Endovascular Therapy ◽  
Acute Ischaemic Stroke ◽  
Data Extraction ◽  
Meta Analysis ◽  
Poor Functional Outcome ◽  
Eligibility Criteria ◽  
Contrast Extravasation

ObjectiveContrast extravasation (CE) after endovascular therapy (EVT) is commonly present in acute ischaemic stroke (AIS) patients. Substantial uncertainties remain about the relationship between CE and the outcomes of EVT in patients with AIS. Therefore, we aimed to evaluate this association.DesignA systematic review and meta-analysis of published studies were performed.Data sourceWe systematically searched the Medline and Embase databases for relevant clinical studies. The last literature search in databases was performed in June 2020.Eligibility criteria for study selectionWe included studies exploring the associations between CE and the outcomes of EVT in patients with AIS undergoing EVT.Data extraction and synthesisTwo reviewers extracted relevant information and data from each article independently. We pooled ORs with CIs using a random-effects meta-analysis to calculate the associations between CE and outcomes of EVT. The magnitude of heterogeneity between estimates was quantified with the I2 statistic with 95% CIs.ResultsFifteen observational studies that enrolled 1897 patients were included. Patients with CE had higher risks of poor functional outcome at discharge (2.38, 95% CI 1.45 to 3.89 p=0.001; n=545) and poor functional outcome at 90 days (OR 2.16, 95% CI 1.20 to 3.90; n=1194). We found no association between CE and in-hospital mortality (OR 0.95, 95% CI 0.27 to 3.30; n=376) or 90-day mortality (OR 1.38, 95% CI 0.81 to 2.36; n=697) after EVT. Moreover, CE was associated with higher risks of post-EVT intracranial haemorrhage (ICH) (OR 6.68, 95% CI 3.51 to 12.70; n=1721) and symptomatic ICH (OR 3.26, 95% CI 1.97 to 5.40; n=1092).ConclusionsThis systematic review and meta-analysis indicates that in patients with AIS undergoing EVT, CE is associated with higher risks of unfavourable functional outcomes and ICH. Thus, we should pay more attention to CE in patients with AIS undergoing EVT.

Abstract 215: Does the CT Angiography Spot Sign Identify Intracerebral Hemorrhage Patients More Likely to Benefit From Intensive Blood Pressure Reduction?

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Andrea Morotti ◽  
Bart H Brouwers ◽  
Javier M Romero ◽  
Michael J Jessel ◽  
Anastasia Vashkevich ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Intracerebral Hemorrhage ◽  
Functional Outcome ◽  
Strong Predictor ◽  
Blood Pressure Reduction ◽  
Standard Group ◽  
Inclusion Criteria ◽  
Multivariable Logistic Regression Model ◽  
Spot Sign ◽  
Intensive Blood Pressure

Background and Purpose: the computed tomography angiography (CTA) spot sign is a strong predictor of intracerebral hemorrhage (ICH) expansion, and may mark those most likely to benefit from intensive blood pressure (BP) reduction. The Spot Sign score in restricting ICH growth (SCORE-IT) study analyzed whether intensive BP reduction improved outcome in Spot Sign positive patients enrolled in the Antihypertensive Treatment of Acute Cerebral Hemorrhage II (ATACH-2) clinical trial. Methods: In ATACH-2, patients with ICH were randomly assigned to intensive (systolic BP target: 110-139 mmHg) versus standard (systolic BP target: 140-179 mmHg) BP treatment within 4.5 h from stroke onset. This analysis included patients with a CTA performed within 8 hours from onset. The association between intensive BP lowering, ICH expansion and functional outcome was investigated with a multivariable logistic regression model. Results: 133 subjects met the inclusion criteria, of whom 53 (39.9%) had a spot sign and 24/123 (19.5%) experienced ICH expansion. A total of 56/123 patients had a 90 day modified Rankin scale (mRS) >3 (45.5%). Among Spot positive patients, 74.1% of those in the intensive BP lowering group had poor outcome, compared with 50.0% of those in the standard group (p=0.31). After adjustment for potential confounders, intensive BP lowering was not associated with a significant reduction of ICH expansion (odds ratio [OR] 0.83, 95% confidence interval [CI] 0.27 - 2.51, p = 0.74) or improved functional outcome (OR for mRS>3 1.24, 95% CI 0.53 - 2.91, p = 0.62) in spot sign positive ICH patients. Conclusions: We found no evidence that ICH patients with a spot sign specifically benefit from intensive BP reduction.

scholarly journals Prediabetes is associated with poor functional outcome in patients with intracerebral hemorrhage

2020 ◽  
Vol 10 (4) ◽  
Author(s):  
Qiongzhang Wang ◽  
Guiqian Huang ◽  
Fei Chen ◽  
Pinglang Hu ◽  
Wenwei Ren ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Functional Outcome ◽  
Poor Functional Outcome

Prognostic Significance of Serum Magnesium in Acute Intracerebral Hemorrhage Patients

2019 ◽  
Vol 16 (2) ◽  
pp. 123-128 ◽  
Author(s):  
Xianjun Han ◽  
Shoujiang You ◽  
Zhichao Huang ◽  
Qiao Han ◽  
Chongke Zhong ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Functional Outcome ◽  
Clinical Outcomes ◽  
Serum Magnesium ◽  
Prognostic Significance ◽  
Stroke Severity ◽  
Linear Regression Models ◽  
Poor Functional Outcome ◽  
All Cause Mortality ◽  
Acute Intracerebral Hemorrhage

Background: Experimental animal model studies have shown neuroprotective properties of magnesium. We assessed the relationship between admission magnesium and admission stroke severity and 3-month clinical outcomes in patients with acute intracerebral hemorrhage (ICH). Methods: The present study included 323 patients with acute ICH who were prospectively identified. Demographic characteristics, lifestyle risk factors, National Institute of Health Stroke Scale (NIHSS) score, hematoma volumes, and other clinical features were recorded at baseline for all participants. Patients were divided into three groups based on the admission magnesium levels (T1: <0.84; T2: 0.84-0.91; T3: =0.91 mmol/L). Clinical outcomes were death, poor functional outcome (defined by modified rankin ccale [mRS] scores 3-6) at 3 months. Results: After 3-month follow-up, 40 (12.4%) all-cause mortality and 132 (40.9%) poor functional outcome were documented. Median NIHSS scores for each tertile (T1 to T3) were 8.0, 5.5, and 6.0, and median hematoma volumes were 10.0, 8.05, and 12.4 ml, respectively. There was no significant association between baseline NIHSS scores (P=0.176) and hematoma volumes (P=0.442) in T3 and T1 in multivariable linear regression models. Compared with the patients in T1, those in T3 were associated with less frequency of all-cause mortality [adjusted odds ratio (OR), 0.10; 95% confidence interval (CI), 0.02-0.54; P-trend=0.010] but not poor functional outcome (adjusted OR, 1.80; 95%CI, 0.71-4.56; P-trend=0.227) after adjustment for potential confounders. Conclusion: Elevated admission serum magnesium level is associated with lower odds of mortality but not poor functional outcome at 3 months in patients with acute ICH.

Abstract P440: Inpatient Blood Pressure Variability is Associated With Mortality and Poor Functional Outcome in Patients With Intracerebral Hemorrhage

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Evangelos Pavlos Myserlis ◽  
Jessica R Abramson ◽  
Haitham Alabsi ◽  
Christopher D Anderson ◽  
Alessandro Biffi ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Intracerebral Hemorrhage ◽  
Functional Outcome ◽  
Blood Pressure Variability ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Poor Functional Outcome ◽  
Logistic Regression Models ◽  
Established Risk Factor ◽  
The Impact

Introduction: Although elevated blood pressure (BP) is an established risk factor for intracerebral hemorrhage (ICH), the impact of acute BP fluctuations on ICH outcomes remains unclear. In this study, we sought to investigate the effect of acute BP variability (BPV) on mortality and functional outcome in ICH survivors. Methods: Subjects were consecutive ICH patients ≥ 18 years with available inpatient BP data, who survived hospitalization. Four measures of systolic BPV were calculated: standard deviation (SD), coefficient of variation (CoV), average real variability (ARV), and successive variation (SV). Our outcomes were (1) death and (2) poor functional outcome, defined as a modified Rankin Score (mRS) of 3-6 in a period between 60-120 days after discharge. We assessed the effect of hyperacute (ICH event-72 hours) and acute/subacute (72 hours-discharge) BPV on outcomes. We constructed Cox proportional hazards and logistic regression models to investigate the associations of BPV (per 10 mmHg increase) with mortality and poor functional outcome, respectively, after adjustment for potential confounders. Results: We included 345 patients, 120 of whom had available mRS data. 151 (43.8%) patients were female and 280 (81.2%) were white; mean age was 71 (±13) years. SBP ARV and SBP SV were the strongest predictors of mortality (HR 2.53-2.91 per 10 mmHg increase), while SBP SD, CoV, and SV were the strongest predictors of poor functional outcome (OR 2.89-5.14 per 10 mmHg increase) (Table) . These associations remained significant when analyzing both hyperacute as well as acute/subacute BPV. Compared to hyperacute BPV, acute/subacute BPV was more strongly associated with both mortality and poor functional outcome. Conclusion: Inpatient blood pressure variability is an important determinant of mortality and poor functional outcome in ICH survivors. Further studies are needed to investigate the role of addressing BPV as a potential target for intervention.

Abstract T MP65: Rate of Peri-Hematomal Edema Expansion Predicts Outcome After Intracerebral Hemorrhage

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Sebastian Urday ◽  
Lauren A Beslow ◽  
David Goldstein ◽  
Feng Dai ◽  
Fan Zhang ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Functional Outcome ◽  
Symptom Onset ◽  
Intraventricular Hemorrhage ◽  
Strong Association ◽  
Expansion Rate ◽  
Multivariable Model ◽  
Hematoma Volume ◽  
Poor Functional Outcome ◽  
The Relationship

Background and Purpose: There have been conflicting reports regarding the association between peri-hematomal edema (PHE) in spontaneous intracerebral hemorrhage (ICH) and outcome. We hypothesized that PHE expansion rate from baseline to 24 hours predicts mortality and poor functional outcome after ICH. Methods: ICH, PHE and intraventricular hemorrhage volumes were measured for 139 subjects who presented with primary ICH and received head computed tomography scans at baseline and 24-hours post-ICH. Subjects were retrospectively identified from a prospective cohort study of ICH. Inclusion criteria were age over 18 years with primary spontaneous supratentorial ICH. Exclusion criteria were infratentorial hemorrhage, primary intraventricular hemorrhage, or any suspected cause of secondary ICH. Logistic regression was performed to evaluate the relationship between PHE expansion rate and 90-day mortality and functional outcome. Poor functional outcome was defined as a modified Rankin Scale (mRS) score > 2. Results: There was a strong association between PHE expansion rate and mortality (OR 1.42, p = 0.0025) and a trend in the correlation between PHE expansion rate and poor outcome (OR 1.50, p = 0.07). In a multivariable model accounting for hematoma volume and time from symptom onset to 24 hour scan, PHE expansion rate was a significant predictor of mortality (OR 1.07, p = 0.032). In a multivariable model accounting for hematoma volume, age, Glasgow Coma Scale score, presence of intraventricular hemorrhage and time from symptom onset to 24 hour scan, PHE expansion rate predicted poor functional outcome (OR 2.58, p = 0.05). Conclusions: PHE expansion rate predicts outcome in ICH and may represent a novel therapeutic target.

scholarly journals Low hemoglobin is associated with poor functional outcome after non-traumatic, supratentorial intracerebral hemorrhage

Critical Care ◽  
2010 ◽  
Vol 14 (2) ◽  
pp. R63 ◽  
Author(s):  
Jennifer Diedler ◽  
Marek Sykora ◽  
Philipp Hahn ◽  
Kristin Heerlein ◽  
Marion N Schölzke ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Functional Outcome ◽  
Poor Functional Outcome

Prognostic Significance of Estimated Glomerular Filtration Rate and Cystatin C in Patients with Acute Intracerebral Hemorrhage

2016 ◽  
Vol 42 (5-6) ◽  
pp. 455-463 ◽  
Author(s):  
Shoujiang You ◽  
Luyao Shi ◽  
Chongke Zhong ◽  
Jiaping Xu ◽  
Qiao Han ◽  
...  
Keyword(s):  
Glomerular Filtration Rate ◽  
Intracerebral Hemorrhage ◽  
Functional Outcome ◽  
Glomerular Filtration ◽  
Cystatin C ◽  
Filtration Rate ◽  
Estimated Glomerular Filtration Rate ◽  
Poor Functional Outcome ◽  
Increased Risk ◽  
All Cause Mortality

Background: The effects of the estimated glomerular filtration rate (eGFR) and cystatin C on clinical outcomes on intracerebral hemorrhage (ICH) remain unclear. We investigated the associations of eGFR and cystatin C with 3-month functional outcome and all-cause mortality in acute ICH patients. Methods: A total of 365 patients with acute ICH were enrolled. Serum creatinine and cystatin C levels were measured within 24 h of admission. Outcomes at 3-month were evaluated by interviews with patients or their family members. Poor functional outcome was defined as a modified Rankin Scale score ≥3. Results: During the 3-month follow-up, 154 patients experienced poor functional outcome, and 48 patients died from all causes. Low eGFR level was associated with poor outcome (adjusted OR 8.95; 95% CI 2.13-37.66; p-trend = 0.045) and all-cause mortality (adjusted hazards ratio (HR) 5.10; 95% CI 2.00-13.03; p-trend = 0.001). Additionally, a high cystatin C level was also found to be associated with all-cause mortality (adjusted HR 4.01; 95% CI 1.09-14.72; p-trend = 0.015). However, no significant association between cystatin C and poor functional outcome was observed (p-trend = 0.615). Conclusions: Low eGFR at baseline predicts poor functional outcome and all-cause mortality at 3-month in acute ICH patients. Also, high cystatin C was associated with increased risk of mortality but not with poor functional outcome.

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