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  • 1
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    Safety and efficacy of minimally invasive surgery plus alteplase in intracerebral haemorrhage evacuation (MISTIE): a randomised, controlled, open-label, phase 2 trial
    Elsevier BV ; 2016
    In:  The Lancet Neurology Vol. 15, No. 12 ( 2016-11), p. 1228-1237
    Details
    In: The Lancet Neurology, Elsevier BV, Vol. 15, No. 12 ( 2016-11), p. 1228-1237
    Type of Medium: Online Resource
    ISSN: 1474-4422
    URL: Article
    DOI: 10.1016/S1474-4422(16)30234-4
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2016
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  • 2
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    Influence of Intracerebral Hemorrhage Location on Outcomes in Patients With Severe Intraventricular Hemorrhage
    Ovid Technologies (Wolters Kluwer Health) ; 2019
    In:  Stroke Vol. 50, No. 7 ( 2019-07), p. 1688-1695
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 50, No. 7 ( 2019-07), p. 1688-1695
    Abstract: We investigated the prognostic significance of spontaneous intracerebral hemorrhage location in presence of severe intraventricular hemorrhage. Methods— We analyzed diagnostic computed tomography scans from 467/500 (excluding primary intraventricular hemorrhage) subjects from the CLEAR (Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage) III trial. We measured intracerebral hemorrhage engagement with specific anatomic regions, and estimated association of each region with blinded assessment of dichotomized poor stroke outcomes: mortality, modified Rankin Scale score of 4 to 6, National Institutes of Health Stroke Scale score of 〉 4, stroke impact scale score of 〈 60, Barthel Index 〈 86, and EuroQol visual analogue scale score of 〈 50 and 〈 70 at days 30 and 180, respectively, using logistic regression models. Results— Frequency of anatomic region involvement consisted of thalamus (332 lesions, 71.1% of subjects), caudate (219, 46.9%), posterior limb internal capsule (188, 40.3%), globus pallidus/putamen (127, 27.2%), anterior limb internal capsule (108, 23.1%), and lobar (29, 6.2%). Thalamic location was independently associated with mortality (days 30 and 180) and with poor outcomes on most stroke scales at day 180 on adjusted analysis. Posterior limb internal capsule and globus pallidus/putamen involvement was associated with increased odds of worse disability at days 30 and 180. Anterior limb internal capsule and caudate locations were associated with decreased mortality on days 30 and 180. Anterior limb internal capsule lesions were associated with decreased long-term morbidity. Conclusions— Acute intracerebral hemorrhage lesion topography provides important insights into anatomic correlates of mortality and functional outcomes even in severe intraventricular hemorrhage causing obstructive hydrocephalus. Models accounting for intracerebral hemorrhage location in addition to volumes may improve outcome prediction and permit stratification of benefit from aggressive acute interventions. Clinical Trial Registration— URL: https://www.clinicaltrials.gov . Unique identifier: NCT00784134.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.118.024187
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2019
    detail.hit.zdb_id: 1467823-8
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  • 3
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    Abstract WP338: Effect of Thalamic Hemorrhage Localization on Level of Consciousness and Functional Outcomes in the CLEAR III Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2018
    In:  Stroke Vol. 49, No. Suppl_1 ( 2018-01-22)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 49, No. Suppl_1 ( 2018-01-22)
    Abstract: Introduction: Thalamic hemorrhages account for 10-15% of intracerebral hemorrhages (ICH) and have a variety of clinical manifestations. We investigated the relationship between injury to thalamus and intra-thalamic regions with level of consciousness and functional outcomes among CLEAR-III trial participants. Methods: We analyzed diagnostic CT scans of 500 patients from CLEAR-III trial prior to randomization and identified the anatomic localization of ICH. Thalamic hemorrhages were further divided into 5 groups: dorsal, anterior, medial, central, and posterolateral. Blinded level of consciousness measures (Glasgow Coma Score (GCS) and question 1a of the National Institutes of Health Stroke Scale (NIHSS)) and stroke severity indices (including mortality and modified Rankin Scale (mRS)) were analyzed. We assessed association of each region with level of consciousness and stroke severity measures using multivariate logistic regression models. Major disability was defined as mRS 4-5. Outcome models were adjusted for ICH volume, IVH (intraventricular hemorrhage) volume, and age. Results: Thalamic ICH was present in 332 patients (71%, 33 with primary IVH were excluded). Initial median GCS was similar in patients with (10, IQR 7-14) and without (10, IQR 6-14) thalamic lesion (P=0.72). At day 30 and 180, thalamic ICH was associated with increased mortality (OR 2.48, CI 0.92-6.63 and OR 2.03, CI 1.02-4.06), major disability (OR 2.44, CI 0.87-6.81 and OR 2.50, CI 1.08-5.75), and death or major disability (OR 2.57, CI 0.91-7.19 and OR 2.71, CI 1.37-5.38), respectively. Thalamic ICH involved medial, central, posterolateral, dorsal, and anterior regions in 51.8%, 48.8%, 48.6%, 56.8%, and 47% of cases, respectively. On day 7, only involvement of the medial thalamus was associated with decreased consciousness defined as GCS 〈 =8 and NIHSS question 1a 〉 =2 (P=0.024 and 0.043, respectively). While all thalamic regions were associated with worse mRS, none were associated with decreased consciousness at day 180. Conclusion: Thalamic hemorrhages are associated with poor functional outcomes. Medial thalamus involvement affects consciousness acutely but not in the long term. The mechanism by which medial thalamus alters consciousness merits investigation.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.49.suppl_1.WP338
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2018
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  • 4
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    Abstract TP348: Predicting 365 Day Outcomes for Spontaneous Intracerebral Hemorrhage And Intraventricular Hemorrhage Survivors With Poor Outcome on Day 30
    Ovid Technologies (Wolters Kluwer Health) ; 2018
    In:  Stroke Vol. 49, No. Suppl_1 ( 2018-01-22)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 49, No. Suppl_1 ( 2018-01-22)
    Abstract: Objective: Prediction of long-term functional outcome in spontaneous intracerebral and intraventricular hemorrhage (ICH/IVH) is typically based on a limited number of severity factors known on admission. We investigated whether factors known at day 30 including medical comorbidities and in-hospital events in poor outcome survivors could accurately predict good vs. poor functional outcome at day 365. Methods: We explored the relationship between ICH severity factors, medical comorbidities, prospectively collected and adjudicated events during first 30 days post ictus, and outcomes using data from the Clot Lysis: Evaluating Accelerated Resolution of Hemorrhage with Alteplase (CLEAR III) trial. We defined outcome using blinded assessment of mortality and modified Rankin scale (mRS) at 30 and 365 days ( 〉 3 signifying poor outcome). Multivariable logistic regression was used to predict mRS at day 365 from poor outcome survivors at day 30. Results: Of 500 patients included in CLEAR III with ICH and severe IVH requiring external ventricular drainage, 345 (69%) had mRS 4 or 5 on day 30. The best performing model for distinguishing between patients with and without good outcome at 365 days included: age (Odds Ratio [OR], 0.93; 95% Confidence Interval [CI] , 0.90- 0.96), COPD (OR, 0.17; CI, 0.04-0.80), diabetes (OR, 0.50; CI, 0.25-0.98), hyperlipidemia (OR, 2.07; CI, 1.01-4.27), bacterial ventriculitis (OR, 0.34; CI, 0.13-0.91), cerebral perfusion pressure 〈 50 mmHg during first week (OR, 0.08; CI, 0.01-0.50), absent IVH on day 30 CT scan (OR, 3.08; CI, 1.69-5.62), enrollment (e) eICH volume (OR, 0.91; CI, 0.87-0.95), eIVH volume (OR, 0.97; CI, 0.95-0.99), thalamic ICH location (OR, 0.29; CI, 0.14-0.60), and eGlasgow Coma Scale (OR, 1.15; CI, 0.1.06-1.26). Cross-validated area under ROC curve (95%CI) was 0.81 (0.77-0.86) vs. 0.78 (0.73-0.82) for standard ICH prediction model with only enrollment predictors. Conclusions: Among patients with spontaneous ICH and IVH requiring external ventricular drainage, 30-day prediction models for long-term functional outcomes have substantial predictive capability. Addition of medical comorbidities and in-hospital events to models using well-known ICH severity factors is of some value.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.49.suppl_1.TP348
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2018
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  • 5
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    Abstract 215: Evaluation of Intracranial Pressure and Cerebral Perfusion Pressure in the Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Trial (CLEAR III)
    Ovid Technologies (Wolters Kluwer Health) ; 2016
    In:  Stroke Vol. 47, No. suppl_1 ( 2016-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 47, No. suppl_1 ( 2016-02)
    Abstract: Background: Elevated intracranial pressure (ICP) and inadequate cerebral perfusion pressure (CPP) are mechanisms causing poor outcomes in spontaneous intraventricular hemorrhage (IVH). We characterized intracranial hypertension in severe IVH requiring extraventricular drainage (EVD). Methods: Prospective analysis of ICP in all 500 patients enrolled in the CLEAR III trial, a multicenter, double-blind, randomized study comparing EVD + intraventricular recombinant tissue plasminogen activator (rtPA) vs. EVD + placebo for treatment of obstructive IVH and intracerebral hemorrhage (ICH) volume 〈 30cc. Maximum and minimum ICP/CPP were recorded every 4 hours until 7 days post randomization (rand), analyzed at pre-defined thresholds and compared by clinical and radiological variables. Results: of 23,406 ICP readings, maximum ICP ranged from 0-97 mmHg (median, IQR; 11,8); 90.7% (21,223) were ≤20mmHg, 1.8% 〉 30, 0.5% 〉 40, and 0.2% 〉 50mm Hg. Proportion of threshold events 〉 20mmHg were more frequent with persistent closure of the lower ventricular system after day 3 (p=0.02), and was correlated with initial and end of treatment (72 hours post rand) ICH volumes (p=0.01, p=0.04, respectively). ICP elevation 〉 20mmHg occurred during a required 1 hr EVD closure interval after 566/3712 (15.3%) study agent injections. Early re-opening of the EVD occurred in 3.9%. Shunting for hydrocephalus occurred in 18.6% over 1 year follow-up and was associated with % of high ICP events 〉 20 and 30 mmHg (p=0.01 for both). After adjustment for ICH severity factors and IVH volume, % of ICP readings 〉 20 mmHg was significantly associated with 30 and 180 day mortality (p=0.01; p=0.03 respectively), and borderline with modified Rankin Scale (mRS4-6) (p=0.09; p=0.11 respectively). Proportion of CPP readings 〈 70mmHg was associated with day 30 poor mRS (p=0.02), with a weaker association for day 180 mRS (p=0.07). Conclusions: Elevated ICP and inadequate CPP are not infrequent during monitoring and EVD drainage in severe IVH and predict higher short and long-term mortality. Early opening of the lower ventricular system may reduce high ICP events. These results permit future correlation of ICP and CPP with treatment rendered (thrombolysis vs placebo), with upcoming unblinding of the trial.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.47.suppl_1.215
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2016
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  • 6
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    Abstract 148: Evaluation of Sex, Racial and Geographic Demographics and Outcomes in Clinical Trials of Spontaneous Intracerebral Hemorrhage
    Ovid Technologies (Wolters Kluwer Health) ; 2017
    In:  Stroke Vol. 48, No. suppl_1 ( 2017-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 48, No. suppl_1 ( 2017-02)
    Abstract: Introduction: As large clinical trials for spontaneous intracerebral hemorrhage (ICH) increasingly influence management, recruitment of diverse populations must be ensured to fully understand the disease process and benefit of interventions to the general public. There is little data on sex, race and outcomes in ICH trials. We hypothesize that women and geographic minorities are underrepresented in ICH clinical trials and that there exist population specific differences in mortality, functional outcomes and response to interventions. Methods: Pooled analysis of 5456 subjects from the following clinical trials: VISTA (985), INTERACT I (404) and II (2829), STICH II (597), MISTIE II (141) and CLEAR III (500). Patients were grouped by sex, race, and geographic location. Modified Rankin Scale [mRS] was obtained at 30 days and 3 months. Results: More men than women participated in ICH trials (61.9% vs. 38.1%); women were older and more likely to have hypertension; men had more coronary artery disease. Women presented with lower Glasgow Coma scale, higher ICH score and more intraventricular hemorrhage. Day 90 mortality was 13.9% in women and 16.6 % in men (p=0.01); 90 day poor outcome (mRS 3-5) was 57.2% in women and 51.0% in men (p 〈 0.001). Only mortality was significantly different between sexes after adjustment for ICH score. Race representation varied in these clinical trials: 1.5% Hispanic; 6.6% black; 14% Arabic; 31% white and 43.4% Asian. Day 90 mortality and mRS 3-5 were highest in Hispanics (22.1%, 78.3%, respectively) and lowest in Asians (9.5%, 43.8%). Hispanics had higher ICH score, but blacks and Hispanics had lower day 90 mortality compared to whites in adjusted models. Asians had both lower mortality and less day 90 mRS 3-5 vs. whites while Arabics and blacks were more likely to have day 90 mRS 3-5. Study interventions were well balanced by sex and race. Conclusions: Sex and race representation in ICH clinical trials only partially equate to current understanding of epidemiology of ICH. There is a lack of trial evidence from Africa and South America and under-representation of women, Hispanics and blacks. Despite higher ICH severity, Hispanics had lower adjusted mortality risk while males had higher risk and Arabics and blacks had worse adjusted poor outcomes.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.48.suppl_1.148
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2017
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  • 7
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    Abstract WMP86: Evaluation of Cerebrospinal Fluid Dynamics and External Ventricular Drain Management in the Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage trial (CLEAR III)
    Ovid Technologies (Wolters Kluwer Health) ; 2016
    In:  Stroke Vol. 47, No. suppl_1 ( 2016-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 47, No. suppl_1 ( 2016-02)
    Abstract: Background: Acute obstructive hydrocephalus secondary to spontaneous intracerebral/intraventricular hemorrhage (ICH/IVH) requires early cerebrospinal fluid (CSF) drainage to reduce intracranial pressure (ICP). Extensive CSF drainage may reduce IVH clot burden. We characterize CSF dynamics, strategies and impact on end of treatment (EOT) IVH volume (72 hours post randomization [Rand]) in the CLEAR III trial. Methods: Prospective analysis of CSF output in all 500 patients enrolled in the CLEAR III trial, a multicenter, double-blind, randomized study comparing EVD + intraventricular recombinant tissue plasminogen activator (rtPA) vs. EVD + placebo for treatment of obstructive IVH and intracerebral hemorrhage (ICH) volume 〈 30cc. CSF output was recorded every 4 hours until 7 days post Rand, and compared by clinical and radiological variables. Results: Daily median CSF output in the first week was 188cc (IQR: 125, 252). Maximum daily EVD drip settings were 〈 10mmHg in 27.8%, =10 in 44.1% and 〉 10 in 28.1%. Independent predictors of higher daily CSF output after adjustment for initial IVH volume (p=0.04) were lower drip setting (p 〈 0.001), lower age (p 〈 0.001), male sex (p=0.03), dual EVD (p=0.005), CSF protein (p 〈 0.001) and ICP 〉 20mmHg (P=0.007). Both EOT IVH volume and change in IVH volume (ChgIVH) (over 1 st week) were independently associated with total CSF output (P=0.004/ 〈 0.001, respectively), and initial IVH volume (P 〈 0.001/ 〈 0.001)). Early opening of 3 rd and 4 th ventricle (P=0.03) was associated with lower EOT volumes, while CSF protein (P=0.02), and side of EVD ipsilateral to largest IVH (P=0.04) were associated with ChgIVH. Shunting for hydrocephalus was performed in 18.6% over 1 year follow-up and was associated with higher total CSF output over first week (P 〈 0.001). Conclusions: CSF circulation in severe IVH can be assessed by CSF output which is associated with EVD drip management and other clinical variables. EOT IVH volume and IVH volume reduction are important surrogate endpoints which are related to CSF dynamics. VP shunt requirement in spontaneous IVH is associated with early CSF output levels. These results permit future correlation of CSF output with treatment rendered (thrombolysis versus placebo) with upcoming unblinding of the trial.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.47.suppl_1.wmp86
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2016
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  • 8
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    Abstract 94: Mortality Review For The First 400 Patients Enrolled In The Clot Lysis: Evaluation Of Accelerated Resolution Of Intraventricular Hemorrhage Trial (CLEAR III)
    Ovid Technologies (Wolters Kluwer Health) ; 2015
    In:  Stroke Vol. 46, No. suppl_1 ( 2015-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 46, No. suppl_1 ( 2015-02)
    Abstract: Objective: CLEAR III is a Phase III, 500-subject, multicenter, double-blind, randomized study comparing extraventricular drainage (EVD) plus intraventricular recombinant tissue plasminogen activator (rtPA) vs. EVD plus placebo for treatment of intraventricular hemorrhage (IVH) in patients with intracerebral hemorrhage (ICH) volume 〈 30cc. We compared proximate causes of death in the acute and post-hospitalization phase of the first 400 subjects enrolled. Methods: We reviewed serious adverse event (SAE) reports for 106 events that resulted in death within 1 year follow-up. We recorded clinical and volumetric data including ICH and IVH volumes on diagnostic, stability, and end-of-treatment (EOT) computed tomography (CT) scans. EOT was defined as the CT at 72 hours post administration of last dose of test article. Results: Of the first 400 subjects enrolled, 27% (106) died, 12% (47) within 30 days of symptom onset. Median [iqr] time to death was 41.5 [71] days. Mean age (±SEM) was 64.0(±1.0) years. Proximate cause of death was neurologic in 52.8% (56), followed by respiratory (14.1%; 15), cardiac (10.4%; 11), multi-organ failure (5.7%; 6), infection (3.8%; 4) and unknown (11.3%; 12). Withdrawal of care (WOC) occurred in 46.2% (49); the majority of deaths were neurologic. Median time to death depended on proximate cause (p=0.0005): Neurologic deaths occurred at 25.5 [36] days vs. 67 [102] days for non-neurologic deaths (p=0.0002). WOC led to death 22 [53] days after ICH and cardiac arrest at 27 [25] days. Patients with no WOC and non-neurologic death died at 76 [106.5] days after ICH. After adjusting for diagnostic IVH volume, age and WOC, factors independently associated with early (≤30d) vs. later ( 〉 30-365d) death were male gender (p=0.01), lower admission Glasgow coma scale (p=0.02), no pneumonia (p=0.02) and higher EOT IVH volume (trend p=0.06). Conclusion: The CLEAR III mortality rate for the first 400 subjects enrolled remains below literature estimates for severe IVH and is below the pre-specified recruitment suspension threshold of 40%. Approximately half of known causes of death are directly due to neurologic events and occur significantly earlier than non-neurologic causes. Reduction in IVH volume may lower early mortality risk.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.46.suppl_1.94
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2015
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  • 9
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    Permanent CSF shunting after intraventricular hemorrhage in the CLEAR III trial
    Ovid Technologies (Wolters Kluwer Health) ; 2017
    In:  Neurology Vol. 89, No. 4 ( 2017-07-25), p. 355-362
    Details
    In: Neurology, Ovid Technologies (Wolters Kluwer Health), Vol. 89, No. 4 ( 2017-07-25), p. 355-362
    Abstract: To study factors associated with permanent CSF diversion and the relationship between shunting and functional outcomes in spontaneous intraventricular hemorrhage (IVH). Methods: Clot Lysis Evaluation of Accelerated Resolution of Intraventricular Hemorrhage (CLEAR III), a randomized, multicenter, double-blind, placebo-controlled trial, was conducted to determine if pragmatically employed external ventricular drainage (EVD) plus intraventricular alteplase improved outcome, in comparison to EVD plus saline. Outcome measures were predictors of shunting and blinded assessment of mortality and modified Rankin Scale at 180 days. Results: Among the 500 patients with IVH, CSF shunting was performed in 90 (18%) patients at a median of 18 (interquartile range [IQR] 13–30) days. Patient demographics and IVH characteristics were similar among patients with and without shunts. In the multivariate analysis, black race (odds ratio [OR] 1.98; 95% confidence interval [CI] 1.18–3.34), duration of EVD (OR 1.10; CI 1.05–1.15), placement of more than one EVD (OR 1.93; CI 1.13–3.31), daily drainage CSF per 10 mL (OR 1.07; CI 1.04–1.10), and intracranial pressure 〉 30 mm Hg (OR 1.70; CI 1.09–2.88) were associated with higher odds of permanent CSF shunting. Patients who had CSF shunts had similar odds of 180-day mortality, while survivors with shunts had increased odds of poor functional outcome, compared to survivors without shunts. Conclusions: Among patients with spontaneous IVH requiring emergency CSF diversion, those with early elevated intracranial pressure, high CSF output, and placement of more than one EVD are at increased odds of permanent ventricular shunting. Administration of intraventricular alteplase, early radiographic findings, and CSF measures were not useful predictors of permanent CSF diversion.
    Type of Medium: Online Resource
    ISSN: 0028-3878 , 1526-632X
    URL: Article
    DOI: 10.1212/WNL.0000000000004155
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2017
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  • 10
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    A randomized 500-subject open-label phase 3 clinical trial of minimally invasive surgery plus alteplase in intracerebral hemorrhage evacuation (MISTIE III)
    SAGE Publications ; 2019
    In:  International Journal of Stroke Vol. 14, No. 5 ( 2019-07), p. 548-554
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 14, No. 5 ( 2019-07), p. 548-554
    Abstract: Surgical removal of spontaneous intracerebral hemorrhage may reduce secondary destruction of brain tissue. However, large surgical trials of craniotomy have not demonstrated definitive improvement in clinical outcomes. Minimally invasive surgery may limit surgical tissue injury, and recent evidence supports testing these approaches in large clinical trials. Methods and design MISTIE III is an investigator-initiated multicenter, randomized, open-label phase 3 study investigating whether minimally invasive clot evacuation with thrombolysis improves functional outcomes at 365 days compared to conservative management. Patients with supratentorial intracerebral hemorrhage clot volume ≥ 30 mL, confirmed by imaging within 24 h ofknown symptom onset,and intact brainstem reflexes were screened with a stability computed tomography scan at least 6 h after diagnostic scan. Patients who met clinical and imaging criteria (no ongoing coagulopathy; no suspicion of aneurysm, arteriovenous malformation, or any other vascular anomaly; and stable hematoma size on consecutive scans) were randomized to either minimally invasive surgery plus thrombolysis or medical therapy. The sample size of 500 was based on findings of a phase 2 study. Study outcomes The primary outcome measure is dichotomized modified Rankin Scale 0–3 vs. 4–6 at 365 days adjusting for severity variables. Clinical secondary outcomes include dichotomized extended Glasgow Outcome Scale and all-cause mortality at 365 days; rate and extent of parenchymal blood clot removal; patient disposition at 365 days; efficacy at 180 days; type and intensity of ICU management; and quality of life measures. Safety was assessed at 30 days and throughout the study.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/1747493019839280
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2019
    detail.hit.zdb_id: 2211666-7
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