Background and Purpose—Therapeutic hypothermia is a potent neuroprotectant approved for cerebral protection after neonatal hypoxia-ischemia and cardiac arrest. Therapeutic hypothermia for acute isc...

Results of the ICTuS 2 Trial (Intravascular Cooling in the Treatment of Stroke 2).

Nurse-led health coaching programme to improve hospital-to-home transitional care for stroke survivors: A randomised controlled trial

The roots of Pueraria lobata and Scutellaria baicalensis, herbal medicines with a long history of widespread use, have been traditionally prescribed in combination to treat stroke, diabetes, and acute infectious diarrhea in East Asia. Nevertheless, toxicological data on these herbs and their combination are limited. This study investigated the acute and 13-week subchronic toxicity of root extract of P. lobata and S. baicalensis (HT047) for stroke treatment in male and female Sprague-Dawley rats. In the acute toxicity study, HT047 was administered orally at a single dose of 5000 mg/kg. In the subchronic toxicity study, HT047 was administered orally at repeated daily doses of 800, 2000, and 5000 mg/kg/day for 13 weeks, followed by a 4-week recovery period. In the acute toxicity study, there were no deaths or toxicologically significant changes in clinical signs, body weight, and necropsy findings. In the subchronic toxicity study, HT047 at all doses caused no death and no treatment-related adverse effects on food consumption; organ weight; ophthalmologic, urinalysis, and hematological parameters; and necropsy findings of both rat sexes. There were some treatment-related alterations in clinical signs, body weight, and serum biochemistry and histopathological parameters; however, these changes were not considered toxicologically significant because they were resolved during the recovery period or resulted from the pharmacological effects of P. lobata and S. baicalensis. The oral approximate lethal dose (the lowest dose that causes mortality) of HT047 was greater than 5000 mg/kg in male and female rats. The oral no-observed-adverse-effect level of HT047 was greater than 5000 mg/kg/day in rats of both sexes, and no target organs were identified. The present findings support the safety of an herbal extract of P. lobata and S. baicalensis as a therapeutic agent for stroke and further confirm the safety of the combined use of P. lobata and S. baicalensis in clinical practice.

/pdf/safety-evaluation-of-root-extract-of-pueraria-lobata-and-2yecrn4tm6.pdf

Safety evaluation of root extract of Pueraria lobata and Scutellaria baicalensis in rats

Over the last 10 years, there has been stagnation in the number of multinational drug trials in stroke in Europe. One important cause of this is probably the increased burden of laws and regulations that came with the European Union Clinical Trials Directive. The main objective of research regulation and governance should be to protect research participants, their tissues, and data, but the approval systems are complex, regulation is variably interpreted and enforced, and the assessment of studies is often not proportionate to the risk of the research to participants. Such unnecessary barriers should be reduced by simplifying, centralizing, and harmonizing the application process, and by applying regulatory and governance requirements in a way that is proportionate to the potential harms to the patients. The traditional functions of a regulator (in setting, monitoring, and enforcing quality standards) could also be supplemented with an aim to actively help researchers achieve these standards, for example, by giving advice, and ultimately with an aim to facilitate and promote research, for example, by integrating research in everyday clinical practice. Research networks offer one way of integrating research and clinical practice across multiple centers, and can streamline research delivery by supporting researchers deal professionally and efficiently with the regulations and governance requirements.

Regulation and governance of multinational drug trials in stroke: barriers and possibilities.

Background and Purpose: During the first days and weeks after an acute ischemic stroke, patients are prone to complications that can influence further treatment, recovery, and functional outcome. I...

Serious Adverse Events and Their Impact on Functional Outcome in Acute Ischemic Stroke in the WAKE-UP Trial

Background and Purpose—Adverse events (AE) in trial populations present a major burden to researchers and patients, yet most events are unrelated to investigational treatment. We aimed to develop a coherent list of expected AEs, whose incidence can be predicted by patient characteristics that will inform future trials and perhaps general poststroke care. Methods—We analyzed raw AE data from patients participating in acute ischemic stroke trials. We identified events that occurred with a lower 99% confidence bound greater than nil. Among these, we applied receiver operating characteristic principles to select the fewest types of events that together represented the greatest number of reports. Using ordinal logistic regression, we modeled the incidence of these events as a function of patient age, sex, baseline National Institutes of Health Stroke Scale, and multimorbidity status, defining P<0.05 as statistically significant. Results—We analyzed 5775 placebo-treated patients, reporting 21 217 AEs. Among 756...

Characteristic Adverse Events and Their Incidence Among Patients Participating in Acute Ischemic Stroke Trials

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Characteristic Adverse Events and Their Incidence Among Patients Participating in Acute Ischemic Stroke Trials