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  • 1
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    Online Resource
    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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  • 2
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    Symptomatic Hemorrhagic Complications in Clot Lysis: Evaluation of Accelerated Resolution of Intraventricular Hemorrhage Phase III Clinical Trial (CLEAR III): A Posthoc Root-Cause Analysis
    Ovid Technologies (Wolters Kluwer Health) ; 2018
    In:  Neurosurgery Vol. 83, No. 6 ( 2018-12), p. 1260-1268
    Details
    In: Neurosurgery, Ovid Technologies (Wolters Kluwer Health), Vol. 83, No. 6 ( 2018-12), p. 1260-1268
    Type of Medium: Online Resource
    ISSN: 0148-396X , 1524-4040
    URL: Article
    DOI: 10.1093/neuros/nyx587
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2018
    detail.hit.zdb_id: 1491894-8
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  • 3
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    The Incidence of Catheter Tract Hemorrhage and Catheter Placement Accuracy in the CLEAR III Trial
    Springer Science and Business Media LLC ; 2018
    In:  Neurocritical Care Vol. 29, No. 1 ( 2018-8), p. 23-32
    Details
    In: Neurocritical Care, Springer Science and Business Media LLC, Vol. 29, No. 1 ( 2018-8), p. 23-32
    Type of Medium: Online Resource
    ISSN: 1541-6933 , 1556-0961
    URL: Article
    DOI: 10.1007/s12028-017-0492-6
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2018
    detail.hit.zdb_id: 2176033-0
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  • 4
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    Abstract W P252: Bleeding and Infection Risk with External Ventricular Drainage and Thrombolysis for Intraventricular Hemorrhage
    Ovid Technologies (Wolters Kluwer Health) ; 2014
    In:  Stroke Vol. 45, No. suppl_1 ( 2014-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 45, No. suppl_1 ( 2014-02)
    Abstract: Introduction: Retrospective series report varying rates of bleeding and infection with external ventricular drainage (EVD). There have been no prospective studies of these risks with systematic surveillance, threshold definitions or independent adjudication. Hypothesis: Risks of bleeding and infection in the ongoing CLEAR Phase III trial are not higher than those previously reported in EVD case series or earlier dose finding trials. Methods: Cases were prospectively enrolled after placement of EVD for obstructive IVH and randomized to receive thrice daily injections of 1mg/1ml of recombinant tissue plasminogen activator or placebo until clearance of the IVH or maximum 12 doses. All cases received daily CT scans and sampling of cerebrospinal fluid (CSF) for the first week. We counted any detected new hemorrhage or expansion of prior bleed on CT scan by 〉 5ml in volume or 〉 5mm in diameter, after placement of the EVD until 30 days after its removal. Symptomatic bleeds and infections were adjudicated by an independent committee, based on previously articulated criteria. Meta-analysis of published series of EVD placement was compiled using STATA software. Results: Growing or unstable hemorrhage was reported as a cause of exclusion from the trial in 42 of 3,794 cases (1.1%) screened for CLEAR III. The first 175 cases enrolled in CLEAR III have completed adjudication of adverse events. Twenty-five subjects (14.3%) experienced one or more new bleeds or expansions, including 2 symptomatic hemorrhages (1.1%). Four cases (2.3%) had culture proven bacterial meningitis or ventriculitis, although many manifested varying sterile CSF pleocytosis in reaction to IVH. These rates were at the lower respective ranges of confidence intervals presently defined in meta-analysis of published series of EVD. Conclusion: The rates of new bleeds and bacterial meningitis/ventriculitis are very low with EVD for IVH, despite multiple daily injections, blood in the ventricles, the use of thrombolysis in half the cases and generalization to 〉 60 trial sites. Any independent risk related to thrombolysis awaits unblinding of results at trial completion.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.45.suppl_1.wp252
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2014
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  • 5
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    Abstract WMP98: Post-Stroke Depression Predictors Among Intracerebral Hemorrhage Survivors
    Ovid Technologies (Wolters Kluwer Health) ; 2020
    In:  Stroke Vol. 51, No. Suppl_1 ( 2020-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 51, No. Suppl_1 ( 2020-02)
    Abstract: Introduction: Post-stroke depression (PSD) in ischemic stroke is well-documented in the literature, but much less in intracerebral hemorrhage (ICH). We aimed to evaluate the clinical predictors of PSD in a cohort of ICH patients. Methods: 499 randomized ICH subjects in MISTIE-III trial were followed for 1 year. Center for Epidemiologic Studies Depression Scale (CES-D) was assessed at 180 days (D180) post-ICH. A score of CES-D ≥16 were considered depressed. 300 out of 379 survivors responded. Multivariable logistic regression analysis was performed to identify independent predictors of depression at D180 with adjustment for baseline demographic characteristics, ICH hemisphere and severity, and functional recovery, cognition status and patient disposition at day 30 (Model 1) and day 180 (Model 2). Good functional outcome was defined as modified Rankin Scale (mRS) 0-3 vs. 4-5 (poor mRS), cognitive impairment status was defined as screening Mini-Mental State Examination (MMSE) 〈 24 and good patient disposition was defined as patient location at home. Prior use of antidepressants was too small to consider. Results: Using CES-D, 106/300 subjects (35%) were considered depressed at day 180. Both models found that female gender, Hispanic ethnicity, and right hemisphere ICH location were statistically significant predictors of PSD. Poor mRS at D180 was statistically significant D180. Early (D30), but not late cognitive impairment was also significant. Conclusion: Almost 4 out of 10 ICH survivors displayed significant depression as defined by CES-D. Race/ethnicity, gender, ICH hemisphere, and poor functional recovery appear to influence post-stroke depression, while later cognitive impairment, volumetric, age, and later home location were less important.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.51.suppl_1.WMP98
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
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  • 6
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    Abstract 216: Incidence and Severity of Catheter Tract Hemorrhage and EVD Placement Accuracy in the CLEAR-III Trial
    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: Introduction: CLEAR III trial is a multicenter, double-blind, randomized trial comparing external ventricular drainage (EVD) plus intraventricular recombinant tissue plasminogen activator (rtPA) vs. EVD plus placebo for treatment of IVH in patients with obstructive IVH and intracerebral hemorrhage (ICH) volume 〈 30cc. New hemorrhage along the catheter tract (CTH) associated with EVD placement is known to occur but magnitude and significance of CTH is not well understood. We investigated incidence and severity risk factors for CTH in the CLEAR-III trial. Methods: Retrospective analysis of 4698 CT scans from EVD placement through EVD removal in all 500 patients enrolled in CLEAR III. CTH was characterized using an ordinal severity scale and quantified using both manual and threshold based segmentation to calculate a volume. EVD location was graded using a modification of the Kakarla scale for each CT scan. Demographic and clinical data were assessed for pre-specified associations. Results: Incidence of CTH was 44.8% (224/500) which included 318 CTHs (single:160 patients; two:51; three:8; four:8). CTH occurred within first 24 hours of placement in 102 (32%), after 24 hours in 132 (41%), after EVD repositioning/manipulation in 19 (6%), after EVD replacement in 15 (5%), and after EVD removal in 50 (16%). The mean CTH volume was 2.01 ml with a range of 0.1 ml - 57.95 ml. CTH volume was not associated with EVD accuracy, nor number of doses given but increased significantly with the number of catheters placed per patient (p 〈 0.001). Furthermore, Grade 2 or 3 CTH (larger than trace, with or without edema) occurred in 31.8% and were significantly associated with lower platelet count (p=0.047) while grade 2/3 CTH on initial placement were significantly associated with pre-admission antiplatelet agent use (p=0.02). Conclusion: Our data suggest that EVD tract hemorrhages can occur at any point within the acute treatment period with varying severity. Hematologic factors, especially history of antiplatelet agent use may increase risk of larger potentially symptomatic CTH.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.47.suppl_1.216
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2016
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  • 7
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    Bleeding and Infection With External Ventricular Drainage : A Systematic Review in Comparison With Adjudicated Adverse Events in the Ongoing Clot Lysis Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR-III IHV) Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2015
    In:  Neurosurgery Vol. 76, No. 3 ( 2015-03), p. 291-301
    Details
    In: Neurosurgery, Ovid Technologies (Wolters Kluwer Health), Vol. 76, No. 3 ( 2015-03), p. 291-301
    Type of Medium: Online Resource
    ISSN: 0148-396X
    URL: Article
    DOI: 10.1227/NEU.0000000000000624
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2015
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  • 8
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    Prior antiplatelet therapy and haematoma expansion after primary intracerebral haemorrhage: an individual patient-level analysis of CLEAR III, MISTIE III and VISTA-ICH
    BMJ ; 2021
    In:  Journal of Neurology, Neurosurgery & Psychiatry Vol. 92, No. 4 ( 2021-04), p. 364-369
    Details
    In: Journal of Neurology, Neurosurgery & Psychiatry, BMJ, Vol. 92, No. 4 ( 2021-04), p. 364-369
    Abstract: To evaluate the relationship between prior antiplatelet therapy (APT) and outcomes after primary intracerebral haemorrhage (ICH), and assess if it varies by haematoma location. Methods We pooled individual patient data from the Virtual International Stroke Trials Archive-ICH trials dataset, Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage III trial and the Minimally Invasive Surgery Plus Alteplase for Intracerebral Hemorrhage Evacuation Phase III trial. The exposure was APT preceding ICH diagnosis. The primary outcome was haematoma expansion at 72 hours. Secondary outcomes were admission haematoma volume, all-cause mortality, death or major disability (modified Rankin Scale (mRS) score ≥4) and shift in mRS distribution. Mixed-effects models were used to assess the relationship between APT and outcomes. Secondary analyses were stratified by ICH location and study cohort. Results Among 1420 patients with ICH, there were 782 (55.1%) lobar and 596 (42.0%) deep haemorrhages. APT was reported in 284 (20.0%) patients. In adjusted regression models, prior APT was not associated with haematoma expansion (OR, 0.97; 95% CI 0.60 to 1.57), major disability or death (OR, 1.05; 95% CI 0.61 to 1.63), all-cause mortality (OR, 0.89; 95% CI 0.47 to 1.85), admission haematoma volume (beta, −0.17; SE, 0.09; p=0.07) and shift in mRS (p=0.43). In secondary analyses, APT was associated with admission haematoma volume in lobar ICH (beta, 0.25; SE, 0.12; p=0.03), but there was no relationship with other ICH outcomes when stratified by haematoma location or study cohort. Conclusions In a large heterogeneous cohort of patients with ICH, prior APT was not associated with haematoma expansion or functional outcomes after ICH, regardless of haematoma location. APT was associated with admission haematoma volumes in lobar ICH.
    Type of Medium: Online Resource
    ISSN: 0022-3050 , 1468-330X
    URL: Article
    DOI: 10.1136/jnnp-2020-323458
    RVK:
    XA 10000
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 1480429-3
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  • 9
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    Abstract WMP108: A Root-Cause Analysis of Symptomatic Rebleeding With Clot Lysis: Evaluation of Accelerated Resolution of Intraventricular Hemorrhage Phase III Clinical Trial (CLEAR III)
    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: Background: Thrombolytic therapy after intraventricular hemorrhage (IVH) is being used with increasing frequency in recent years, and was recently evaluated in a randomized, placebo controlled blinded prospective clinical trial (CLEAR III). Hemorrhagic complications have remained a concern with thrombolysis in hemorrhagic stroke. We herein present a root case analysis of all cases with adjudicated symptomatic rebleeding identified in the CLEAR III Trial. Methods: We reviewed safety reports on symptomatic rebleeding events encountered within one year from randomization among subjects enrolled in CLEA III trial, with prospectively articulated definitions and reporting standards. Medical and imaging data were retrieved through the trial database. We analyzed clinical presentation, baseline and follow-up imaging, laboratory abnormalities, medical and surgical management aspects that may have contributed to rebleeding. Subjects were individually analyzed and classified according to onset of (dosing period, early post-dosing and delayed) rebleeding, pattern of bleeding and treatment rendered (alteplase vs. saline), and potential factors contributing the rebleeding. Results: Twenty-one subjects developed a secondary symptomatic hemorrhage constituting 4% of subjects in the trial. Symptomatic rebleeding events took place during the dosing protocol (n=9, 6 in the alteplase group), early after the protocol (n=6, 2 in the alteplase group) and late (n=6, none in the alteplase group). Catheter-related hemorrhages were the most common (n=7, 33%) followed by intraventricular (n=6, 30%) and intracerebral hemorrhage (n=5, 25%). Rebleeding during the dosing period resulted from a combination of treatment- and patient-related factors and could be partially attributable to alteplase in 6 of 9 cases. Rebleeding after the dosing protocol was primarily dependent on patients’ risk factors. Conclusion: Overall risk of symptomatic hemorrhagic complications are low after intraventricular thrombolysis for IVH as long as safety protocols are followed as deployed in the clinical trial. Secondary prevention strategies are needed following the acute care phase to minimize rebleeds.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.48.suppl_1.wmp108
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2017
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  • 10
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    Abstract WMP100: Prior Antiplatelet Use and Outcomes After Lobar, Deep, and Intraventricular Hemorrhage
    Ovid Technologies (Wolters Kluwer Health) ; 2019
    In:  Stroke Vol. 50, No. Suppl_1 ( 2019-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 50, No. Suppl_1 ( 2019-02)
    Abstract: Introduction: We examined the association between prior antiplatelet therapy and outcomes in patients with lobar versus deep intracerebral hemorrhage (ICH) versus intraventricular hemorrhage (IVH). Methods: We performed a retrospective cohort study using data from patients with lobar and deep ICH registered in the Virtual International Stroke Trials Archive (VISTA-ICH), and patients with IVH enrolled in the Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (CLEAR) III trial. We excluded patients in the intervention arms of the trials, and those on prior anticoagulation therapy. The exposure was antiplatelet therapy prior to ICH/IVH. Primary outcomes were hematoma expansion and death/major disability in the VISTA-ICH cohort, and ventriculostomy tract hemorrhage, hematoma expansion, and death/major disability in the CLEAR III cohort. We used separate sets of logistic regression models in each group—lobar ICH, deep ICH, and IVH—to examine the association between antiplatelet therapy and our outcomes. Results: Among 548 ICH patients in the VISTA-ICH cohort, there were 416 (75.9%) lobar and 121 (22.1%) deep hematomas. Median baseline ICH volumes were 19 ml (IQR, 11-26) in lobar and 8 ml (IQR, 4-13) in deep bleeds. Prior antiplatelet therapy was reported in 92 patients with lobar (22.1%) and 26 patients (20.8%) patients with deep ICH. After adjustment for demographics, comorbidities, and hematoma characteristics, antiplatelet therapy was not associated with hematoma expansion or poor functional outcomes after lobar (OR, 0.8; 95% CI, 0.5-1.8) or deep (OR, 1.3; 95% CI, 0.4-3.8) ICH. In the CLEAR cohort, the 62 of 222 IVH patients (27.9%) with prior antiplatelet therapy had similar odds of hematoma expansion (OR, 0.6; 95% CI, 0.2-1.7) or poor functional outcomes (OR, 0.9; 95% CI, 0.4-2.1), but higher odds of ventriculostomy tract hemorrhage (OR, 3.2; 95% CI, 1.3-7.7). Conclusions: Prior antiplatelet therapy was not associated with hematoma expansion or functional outcomes after lobar or deep ICH or IVH, but was associated with ventriculostomy tract hemorrhage.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.50.suppl_1.WMP100
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2019
    detail.hit.zdb_id: 1467823-8
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