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  • Ovid Technologies (Wolters Kluwer Health)  (51)
  • 11
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 51, No. 1 ( 2020-01), p. 121-128
    Abstract: Blend, black hole, island signs, and hypodensities are reported to predict hematoma expansion in acute intracerebral hemorrhage. We explored the value of these noncontrast computed tomography signs in predicting hematoma expansion and functional outcome in our cohort of intracerebral hemorrhage. Methods— The TICH-2 (Tranexamic acid for IntraCerebral Hemorrhage-2) was a prospective randomized controlled trial exploring the efficacy and safety of tranexamic acid in acute intracerebral hemorrhage. Baseline and 24-hour computed tomography scans of trial participants were analyzed. Hematoma expansion was defined as an increase in hematoma volume of 〉 33% or 〉 6 mL on 24-hour computed tomography. Poor functional outcome was defined as modified Rankin Scale of 4 to 6 at day 90. Multivariable logistic regression was performed to identify predictors of hematoma expansion and poor functional outcome. Results— Of 2325 patients recruited, 2077 (89.3%) had valid baseline and 24-hour scans. Five hundred seventy patients (27.4%) had hematoma expansion while 1259 patients (54.6%) had poor functional outcome. The prevalence of noncontrast computed tomography signs was blend sign, 366 (16.1%); black hole sign, 414 (18.2%); island sign, 200 (8.8%); and hypodensities, 701 (30.2%). Blend sign (adjusted odds ratio [aOR] 1.53 [95% CI, 1.16–2.03] ; P =0.003), black hole (aOR, 2.03 [1.34–3.08]; P =0.001), and hypodensities (aOR, 2.06 [1.48–2.89]; P 〈 0.001) were independent predictors of hematoma expansion on multivariable analysis with adjustment for covariates. Black hole sign (aOR, 1.52 [1.10–2.11]; P =0.012), hypodensities (aOR, 1.37 [1.05–1.78]; P =0.019), and island sign (aOR, 2.59 [1.21–5.55]; P =0.014) were significant predictors of poor functional outcome. Tranexamic acid reduced the risk of hematoma expansion (aOR, 0.77 [0.63–0.94]; P =0.010), but there was no significant interaction between the presence of noncontrast computed tomography signs and benefit of tranexamic acid on hematoma expansion and functional outcome ( P interaction all 〉 0.05). Conclusions— Blend sign, black hole sign, and hypodensities predict hematoma expansion while black hole sign, hypodensities, and island signs predict poor functional outcome. Noncontrast computed tomography signs did not predict a better response to tranexamic acid. Clinical Trial Registration— URL: https://www.isrctn.com . Unique identifier: ISRCTN93732214.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
    detail.hit.zdb_id: 1467823-8
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  • 12
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 37, No. 12 ( 2006-12), p. 2979-2983
    Abstract: Background and Purpose— Loss of motor function is common after stroke and leads to significant chronic disability. Stem cells are capable of self-renewal and of differentiating into multiple cell types, including neurones, glia, and vascular cells. We assessed the safety of granulocyte-colony–stimulating factor (G-CSF) after stroke and its effect on circulating CD34+ stem cells. Methods— We performed a 2-center, dose-escalation, double-blind, randomized, placebo-controlled pilot trial (ISRCTN 16784092) of G-CSF (6 blocks of 1 to 10 μg/kg SC, 1 or 5 daily doses) in 36 patients with recent ischemic stroke. Circulating CD34+ stem cells were measured by flow cytometry; blood counts and measures of safety and functional outcome were also monitored. All measures were made blinded to treatment. Results— Thirty-six patients, whose mean±SD age was 76±8 years and of whom 50% were male, were recruited. G-CSF (5 days of 10 μg/kg) increased CD34+ count in a dose-dependent manner, from 2.5 to 37.7 at day 5 (area under curve, P =0.005). A dose-dependent rise in white cell count ( P 〈 0.001) was also seen. There was no difference between treatment groups in the number of patients with serious adverse events: G-CSF, 7/24 (29%) versus placebo 3/12 (25%), or in their dependence (modified Rankin Scale, median 4, interquartile range, 3 to 5) at 90 days. Conclusions— G-CSF is effective at mobilizing bone marrow CD34+ stem cells in patients with recent ischemic stroke. Administration is feasible and appears to be safe and well tolerated. The fate of mobilized cells and their effect on functional outcome remain to be determined.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2006
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  • 13
    In: Journal of Hypertension, Ovid Technologies (Wolters Kluwer Health), Vol. 30, No. Supplement 1 ( 2012-09), p. e102-
    Type of Medium: Online Resource
    ISSN: 0263-6352
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2012
    detail.hit.zdb_id: 2017684-3
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  • 14
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 47, No. suppl_1 ( 2016-02)
    Abstract: Introduction: International guidelines recommend the avoidance of DNAR in the first few days after haemorrhagic stroke. Methods: The ongoing TICH-2 records, at days 2 and 7, whether the participant has a DNAR order. Baseline characteristics and outcomes were compared between those that had a DNAR and those that did not. Outcomes included; early death (died on or before day 7), day 90 modified Rankin Scale (mRS), Barthel index (BI), cognition and Euroqol-5D. Results: Of the 926 participants in TICH-2 who reached day 90, 156 (16.8%) participants had a DNAR at day 2 increasing to 194 (21.0%) at day 7; giving a total of 210 (22.7%) people having a DNAR. The patients with a DNAR were found to be older (79 versus 67), more likely to be female (56.2% versus 41.1%) and their average baseline severity (National Institutes of Health Stroke Scale, NIHSS) was worse (19 versus 10). There were 96 early deaths, 92 (95.8%) had a DNAR. Only 4 people without a DNAR died early. Early death, day 90 mRS, BI and Euroqol-5D were significantly worse for the people who had a DNAR (all p-values 〈 0.0001). Cognition (p=0.0321) was also significant. All deaths by day 90 were analysed using a Cox proportional hazards model, giving a hazard ratio of 10.8 (7.2, 16.2), with p 〈 0.0001. All models were adjusted for age, NIHSS and mRS at baseline. Conclusion: Use of DNAR early after intracerebral haemorrhage is common and an independent predictor of death and poor outcome, although use of early DNAR in some patients maybe appropriate.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2016
    detail.hit.zdb_id: 1467823-8
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  • 15
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 47, No. suppl_1 ( 2016-02)
    Abstract: Introduction: After ischaemic stroke (IS) or TIA, recurrence and moderate/major bleeding are each associated with worse outcome. We compared baseline characteristics and outcomes for patients who did and did not have recurrence or bleeding using data from the ongoing TARDIS trial. Method: TARDIS is assessing the safety and efficacy of intensive vs guideline antiplatelet agents in 4,100 patients with acute non-cardioembolic IS or TIA. Information on bleeding, and recurrent IS and TIA is collected up to day 90. Functional outcome are assessed centrally with blinding to treatment assignment at day 90. Data are unadjusted odds ratio (OR) or mean difference (MD) with 95% confidence interval (CI), and do not take account of treatment assignment. Results: In 2697 recruited patients (of a planned 4100), recurrent events (178, 6.6%) were more common in patients with a qualifying event of TIA (p=0.017). Major (51 patients, 1.9%), including fatal (7 patients, 0.3%) bleeding were uncommon. Patients with a recurrence or moderate/major bleeding event had worse outcomes at day 90 than those without such events: more deaths, dependency (modified Rankin Scale), disability (Barthel Index), cognitive impairment (TICS-M), worse quality of life (EQ-5D HUS) and more mood disturbance (Zung depression scale) - all comparisons p 〈 0.001. Conclusion: Recurrent events are more common after TIA. Both recurrence and bleeding are associated with a worse outcome.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2016
    detail.hit.zdb_id: 1467823-8
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  • 16
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 49, No. Suppl_1 ( 2018-01-22)
    Abstract: Background: The risk of recurrence following an ischaemic stroke (IS) or transient ischaemic attack (TIA) is high, especially immediately after the event. Intensive treatment might be more effective in preventing recurrence than guideline therapy providing bleeding does not become excessive. We tested this in a subgroup of patients enrolled with TIA into the TARDIS trial. Methods: TARDIS was an international multicentre prospective randomised open-label blinded-endpoint controlled trial. Patients with acute non-cardioembolic IS or TIA were randomised to intensive antiplatelet therapy (combined aspirin, clopidogrel and dipyridamole) or guideline antiplatelets (clopidogrel alone, or combined aspirin and dipyridamole) given for one month. The primary outcome was recurrent cerebral events and their severity (using modified Rankin Scale) at 3 months. Data are number (%), mean (standard deviation, SD) or odds ratio (OR) with 95% confidence interval (CI). Results: Of 3,096 patients, 953 (30.8%; intensive 480, guideline 473) were enrolled with TIA. At baseline: mean age 70 (SD 10); male 62%; onset to randomisation 〈 12 hours 17%, 〈 24 hours 48%. By day 90, no differences were present between the two treatment groups for the primary outcome, death or other functional outcomes. However, patients in the intensive arm were less likely to suffer a recurrent TIA than those on guideline treatment (OR 0.48, 95% CI 0.25-0.93). Conclusion: Patients with a qualifying event of TIA were less likely to suffer a recurrent TIA if they received intensive treatment rather than guideline. However, no differences were present for recurrent stroke events.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2018
    detail.hit.zdb_id: 1467823-8
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  • 17
    Online Resource
    Online Resource
    Ovid Technologies (Wolters Kluwer Health) ; 2015
    In:  Stroke Vol. 46, No. suppl_1 ( 2015-02)
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 46, No. suppl_1 ( 2015-02)
    Abstract: Background: High blood pressure (BP) is common during the acute phase of stroke and is associated with a poor outcome. Administration of glyceryl trinitrate (GTN), a nitric oxide donor that lowers BP, improved functional outcome in the small ambulance-based paramedic-delivered RIGHT trial. Methods: ENOS was an international prospective randomised single-blind blinded-endpoint trial. Patients with acute ( 〈 48 hours) stroke and systolic BP 140-220 mmHg were randomised to GTN (5 mg transdermal) or no GTN. Outcomes included shift in modified Rankin Scale (mRS, primary), Barthel Index (BI) and death at 3 months. Analyses are by regression (binary, ordinal or multiple) with adjustment for baseline covariates; results are odds ratio (OR)/mean difference (MD) with 95% confidence intervals (95% CI). Results: Of 4,011 enrolled patients, 273 were randomised (GTN 144, no GTN 129) within 6 hours of onset of stroke: age 70 (SD 13); BP 167 (18)/91 (13) mmHg; Scandinavian Stroke Scale 32 (12); ischaemic 76%, ICH 22%; stroke-randomisation 4.6 hours. Treatment with GTN was associated with improved mRS (OR 0.51, 95% CI 0.32-0.80), BI (MD 13.5, 95% CI 4.6 to 22.5), and reduced death (OR 0.31, 95% CI 0.11-0.91). Significant improvements in mood, quality of life and cognition were also seen. Summary: In the subgroup of patients randomised within 6 hours of stroke onset, treatment with GTN was associated with less dependency, disability and death. These positive results mirror those seen in the RIGHT pilot trial.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2015
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  • 18
    Online Resource
    Online Resource
    Ovid Technologies (Wolters Kluwer Health) ; 2016
    In:  Stroke Vol. 47, No. suppl_1 ( 2016-02)
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 47, No. suppl_1 ( 2016-02)
    Abstract: Introduction: There are very few population-based studies on the incidence of stroke in women of childbearing age, stratifying by stroke types and pregnancy-related periods. Methods: We used an open cohort study design including all women aged 15-49 years from UK linked primary (Clinical Practice Research Datalink) and secondary (Hospital Episode Statistics) care records in 1997-2014. The exposure of our study was pregnancy resulting in a live or a stillbirth and associated antenatal and postpartum periods. The outcome of the study was the first ever stroke diagnosis, defined using ICD-10 codes (I60-I64, O22.5 and O87.3) or relevant Read codes, and classified as having ischaemic stroke (IS), intracerebral haemorrhage (ICH), subarachnoid haemorrhage (SAH) or unspecified. We calculated the absolute rates of stroke per 100,000 person-years and 95% confidence intervals (95%CI) for different exposure periods. We stratified the analysis by maternal age and types of stroke. Results: Of 2,047,858 women, we identified 336,957 women with 453,776 deliveries. There were totally 2,526 women with a first incidence of stroke: IS 1,140 (45.1%), SAH 684 (27.1%), ICH 368 (14.6%) and unspecified 334 (13.2%). The overall incidence rate of stroke was 24.9 (95%CI 23.6-26.2) per 100,000 person-years in the non-pregnant period (IS 11.2 [10.4-12.1], ICH 3.6 [3.2-4.2] , SAH 6.8 [6.2-7.5] and unspecified 3.3 [2.9-3.8] ). The incidence was however higher around delivery (281.9 [141.6-561.2]) and in the first six weeks postpartum (43.8 [25.3-75.9] ) and the rate ratios compared to the non-pregnant period after adjusting for age were 19.2 (9.6-38.3) and 3.0 (1.7-5.2) respectively. Conclusions: Although the incidence of stroke for young women was relatively low, the incidence around delivery or in the early postpartum was significantly higher compared to other periods, regardless of maternal age.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2016
    detail.hit.zdb_id: 1467823-8
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  • 19
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 53, No. 4 ( 2022-04), p. 1141-1148
    Abstract: Seeking consent rapidly in acute stroke trials is crucial as interventions are time sensitive. We explored the association between consent pathways and time to enrollment in the TICH-2 (Tranexamic Acid in Intracerebral Haemorrhage-2) randomized controlled trial. Methods: Consent was provided by patients or by a relative or an independent doctor in incapacitated patients, using a 1-stage (full written consent) or 2-stage (initial brief consent followed by full written consent post-randomization) approach. The computed tomography-to-randomization time according to consent pathways was compared using the Kruskal-Wallis test. Multivariable logistic regression was performed to identify variables associated with onset-to-randomization time of ≤3 hours. Results: Of 2325 patients, 817 (35%) gave self-consent using 1-stage (557; 68%) or 2-stage consent (260; 32%). For 1507 (65%), consent was provided by a relative (1 stage, 996 [66%]; 2 stage, 323 [21%] ) or a doctor (all 2-stage, 188 [12%] ). One patient did not record prerandomization consent, with written consent obtained subsequently. The median (interquartile range) computed tomography-to-randomization time was 55 (38–93) minutes for doctor consent, 55 (37–95) minutes for 2-stage patient, 69 (43–110) minutes for 2-stage relative, 75 (48–124) minutes for 1-stage patient, and 90 (56–155) minutes for 1-stage relative consents ( P 〈 0.001). Two-stage consent was associated with onset-to-randomization time of ≤3 hours compared with 1-stage consent (adjusted odds ratio, 1.9 [95% CI, 1.5–2.4]). Doctor consent increased the odds (adjusted odds ratio, 2.3 [1.5–3.5] ) while relative consent reduced the odds of randomization ≤3 hours (adjusted odds ratio, 0.10 [0.03–0.34]) compared with patient consent. Only 2 of 771 patients (0.3%) in the 2-stage pathways withdrew consent when full consent was sought later. Two-stage consent process did not result in higher withdrawal rates or loss to follow-up. Conclusions: The use of initial brief consent was associated with shorter times to enrollment, while maintaining good participant retention. Seeking written consent from relatives was associated with significant delays. Registration: URL: https://www.isrctn.com ; Unique identifier: ISRCTN93732214.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
    detail.hit.zdb_id: 1467823-8
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  • 20
    Online Resource
    Online Resource
    Ovid Technologies (Wolters Kluwer Health) ; 2018
    In:  Stroke Vol. 49, No. 8 ( 2018-08)
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 49, No. 8 ( 2018-08)
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2018
    detail.hit.zdb_id: 1467823-8
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