Objective To assess effect of age on response to alteplase in acute ischaemic stroke. Design Adjusted controlled comparison of outcomes between non-randomised patients who did or did not undergo thrombolysis. Analysis used Cochran-Mantel-Haenszel test and proportional odds logistic regression analysis. Setting Collaboration between International Stroke Thrombolysis Registry (SITS-ISTR) and Virtual International Stroke Trials Archive (VISTA). Participants 23 334 patients from SITS-ISTR (December 2002 to November 2009) who underwent thrombolysis and 6166 from VISTA neuroprotection trials (1998-2007) who did not undergo thrombolysis (as controls). Of the 29 500 patients (3472 aged >80 (“elderly,” mean 84.6), data on 272 patients were missing for baseline National Institutes of Health stroke severity score, leaving 29 228 patients for analysis adjusted for age and baseline severity. Main outcome measures Functional outcomes at 90 days measured by score on modified Rankin scale. Results Median severity at baseline was the same for patients who underwent thrombolysis and controls (median baseline stroke scale score: 12 for each group, P=0.14; n=29 228). The distribution of scores on the modified Rankin scale was better among all thrombolysis patients than controls (odds ratio 1.6, 95% confidence interval 1.5 to 1.7; Cochran-Mantel-Haenszel P 80 (1.4, 1.3 to 1.6; P v 2-6; 0-2 v 3-6; and 6 (death) v rest) were consistent with the results of the ordinal analysis. Conclusions Outcome in patients with acute ischaemic stroke is significantly better in those who undergo thrombolysis compared with those who do not. Increasing age is associated with poorer outcome but the association between thrombolysis treatment and improved outcome is maintained in very elderly people. Age alone should not be a barrier to treatment.

https://www.bmj.com/content/bmj/341/bmj.c6046.full.pdf

Thrombolysis in very elderly people: controlled comparison of SITS International Stroke Thrombolysis Registry and Virtual International Stroke Trials Archive

Over fifty percent of stroke patients experience chronic arm hand performance problems, compromising independence in daily life activities and quality of life. Task-oriented training may improve arm hand performance after stroke, whereby augmented therapy may lead to a better treatment outcome. Technology-supported training holds opportunities for increasing training intensity. However, the effects of robot-supported task-oriented training with real life objects in stroke patients are not known to date. The aim of the present study was to investigate the effectiveness and added value of the Haptic Master robot combined with task-oriented arm hand training in chronic stroke patients. In a single-blind randomized controlled trial, 22 chronic stroke patients were randomly allocated to receive either task-oriented robot-assisted arm-hand training (experimental group) or task-oriented non-robotic arm-hand training (control group). For training, the T-TOAT (Technology-supported Task-Oriented Arm Training) method was applied. Training was provided during 8 weeks, 4 times/week, 2× 30 min/day. A significant improvement after training on the Action Research Arm Test (ARAT) was demonstrated in the experimental group (p = 0.008). Results were maintained until 6 months after cessation of the training. On the perceived performance measure (Motor Activity Log (MAL)), both, the experimental and control group improved significantly after training (control group p = 0.008; experimental group p = 0.013). The improvements on MAL in both groups were maintained until 6 months after cessation of the training. With regard to quality of life, only in the control group a significant improvement after training was found (EuroQol-5D p = 0.015, SF-36 physical p = 0.01). However, the improvement on SF-36 in the control group was not maintained (p = 0.012). No between-group differences could be demonstrated on any of the outcome measures. Arm hand performance improved in chronic stroke patients, after eight weeks of task oriented training. The use of a Haptic Master robot in support of task-oriented arm training did not show additional value over the video-instructed task-oriented exercises in highly functional stroke patients. Current Controlled Trials ISRCTN82787126

/pdf/effects-of-task-oriented-robot-training-on-arm-function-40cq2ttrxg.pdf

Effects of task-oriented robot training on arm function, activity, and quality of life in chronic stroke patients: a randomized controlled trial.

Background Citicoline is a drug approved for the treatment of acute ischemic stroke. Although evidence of its efficacy has been reported, recently published results of a large placebo-controlled clinical trial did not show differences. This study aims to assess whether starting citicoline treatment within 14 days after stroke onset improves the outcome in patients with acute ischemic stroke, as compared with placebo. Methods A systematic search was performed to identify all published, unconfounded, randomized, double-blind, and placebo-controlled clinical trials of citicoline in acute ischemic stroke. Results Ten randomized clinical trials met our inclusion criteria. The administration of citicoline was associated with a significant higher rate of independence, independently of the method of evaluation used (odds ratio [OR] 1.56, 95% confidence interval [CI] = 1.12-2.16 under random effects; OR 1.20, 95% CI = 1.06-1.36 under fixed effects). After studying the cumulative meta-analysis, and with the results obtained with the subgroup of patients who were not treated with recombinant tissue plasminogen activator (rtPA) (OR 1.63, 95% CI = 1.18-2.24 under random effects; OR 1.42, 95% CI = 1.22-1.66 under fixed effects), our hypothesis of dilution of the effect of citicoline was confirmed. When we analyzed the effect of citicoline in patients who were not treated with rtPA and were receiving the highest dose of citicoline started in the first 24 hours after onset, based on more recent trials, there was no heterogeneity, and the size of the effect has an OR of 1.27 (95% CI = 1.05-1.53). Conclusions This systematic review supports some benefits of citicoline in the treatment of acute ischemic stroke. But, on top of the best treatment available (rtPA), citicoline offers a limited benefit.

Citicoline for Acute Ischemic Stroke: A Systematic Review and Formal Meta-analysis of Randomized, Double-Blind, and Placebo-Controlled Trials.

Background: Contemporaneous data on variations in outcome after first-ever-lifetime stroke between European populations are lacking. We compared differences in case fatality rates, functional outcome, and living conditions 3 months after stroke within the European Registers of Stroke Collaboration. Methods: Population-based stroke registers were established in France (Dijon), Italy (Sesto Fiorentino), Lithuania (Kaunas), the United Kingdom (London), Spain (Menorca), and Poland (Warsaw). All patients with first-ever-lifetime stroke of all age groups from the source population (1,087,048 inhabitants) were included. Data collection took part between 2004 and 2006. The study investigated population variations in outcome at 3 months (death, institutionalization due to stroke, or Barthel Index below 12 points) using multivariable logistic regression analyses adjusted for age, sex, stroke severity, stroke subtype, and comorbidities. Results: A total of 2,034 patients with first-ever-lifetime stroke were included. Median age was 73 years, 52% were female. The mean weighted cumulative risk of death was 21.8% (95% confidence interval 20.0 to 23.6) with a 3-fold variation across populations. The weighted proportion of poor outcome was 41.3% (95% confidence interval 39.0 to 43.7) with a 2-fold variation across populations. Conclusion: More than 40% of patients had a poor outcome, defined as being dead, dependent, or institutionalized 3 months after stroke. Substantial outcome variations were found between populations that were explained by case mix variables in this analysis, yet a trend toward a higher risk of poor outcome was present in Kaunas.

Three-month stroke outcome: the European Registers of Stroke (EROS) investigators.

Background: Animal studies show a neuroprotective effect of serum albumin in ischemic stroke. The neuroprotective effect of albumin in ischemic stroke in humans is not well studied.

Serum albumin in ischemic stroke patients: the higher the better. The Bergen Stroke Study

Background and Purpose—Stroke incidence and outcome vary widely within and across geographical locations. We
examined whether differences in index stroke severity, stroke risk factors, mortality, and stroke outcome across
geographical locations remain after adjusting for case mix.
Methods—We analyzed 3284 patients from the Virtual International Stroke Trials Archive (VISTA). We used logistic regression to examine the incidence of mild index stroke, functional, and neurological outcomes after accounting for age, medical history, year of trial recruitment, and initial stroke severity in the functional and neurological outcome analyses. We examined mortality between geographical regions using a Cox proportional hazards model, accounting for age, initial stroke severity, medical history, and year of trial recruitment.
Results—Patients enrolled in the USA and Canada had the most severe index strokes. Those recruited in Austria and
Switzerland had the best functional and neurological outcomes at 90 days (P0.05), whereas those enrolled in Germany had the worst functional outcome at 90 days (P0.013). Patients enrolled in Austria, Switzerland, Belgium, Netherlands, Finland, Germany, Greece, Israel, Spain, and Portugal had a significantly better survival rate when compared with those enrolled in USA and Canada. Patients enrolled in trials after 1998 had more severe index strokes, with no significant difference in outcome compared with those enrolled before 1998.
Conclusion—We identified regional variations in index stroke severity, outcome, and mortality for patients enrolled in ischemic stroke clinical trials over the past 13 years that were not fully explained by case mix. Index stroke severity was greater in patients enrolled after 1998, with no significant improvement in outcomes compared to those enrolled before 1998. (Stroke. 2009;40:000-000.)

/pdf/stroke-outcome-in-clinical-trial-patients-deriving-from-4fzcwtlzah.pdf

Stroke Outcome in Clinical Trial Patients Deriving From Different Countries

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Stroke Outcome in Clinical Trial Patients Deriving From Different Countries