OBJECTIVETo assess the long-term (up to 6 months) safety profile of a 3-month regimen of NeuroAiD for acute ischemic stroke.

METHODSA total of 190 patients with acute ischemic stroke were identified for eligibility in a randomized, double-blind, placebo-controlled clinical trial, of which 150 patients allocated to either receiving NeuroAiD (80 cases) or placebo (70 cases) were analyzed after dropouts due to absence of baseline data, early death, or noncompliance. Both groups received treatment for three months and followed up for another three months after the completion of the treatment. Occurrence of clinical adverse events and laboratory parameters were assessed at 1 month, 3 months (while under treatment) and 6 months (3 months after the completion of treatment). Statistical comparisons between groups were performed using chi-square test or t-test whenever appropriate.

RESULTSThe two groups had comparable baseline characteristics. Mild nausea was more commonly reported in patients taking NeuroAid compared with placebo (P=0.01), of which 9 out of 10 were observed only during the first month of treatment. However, none of the adverse events reported were considered severe or required discontinuation of the study drug. There was no significant change observed in mean arterial blood pressure, haemoglobin, renal and liver laboratory parameters during treatment with NeuroAid and up to 3 months after completion of a 3-month regimen.

CONCLUSIONNeuroAiD is safe and does not affect hematologic, hepatic, and renal functions during and long after completion of treatment.

Aged ; Brain Ischemia ; therapy ; Double-Blind Method ; Female ; Humans ; Male ; Patient Compliance ; Placebos ; Stroke ; therapy

BACKGROUND AND PURPOSE: Sickle cell disease (SCD) is strongly linked to stroke across all haplotypes in the pediatric population. Transcranial Doppler (TCD) ultrasound is known to identify the highest risk group in African-Americans who need to receive and stay on blood transfusions, but it is unclear if the same flow velocity cut-offs can be applied to the Iranian population. We aimed to evaluate baseline TCD findings in Iranian children with SCD and no prior strokes. METHODS: Children with genetically confirmed SCD (Arabian haplotype, homozygote) and without SCD (controls) were prospectively recruited from pediatric outpatient clinic over a period of 9 months. We performed TCD in both groups to determine flow velocities in the middle cerebral (MCA) and terminal internal carotid arteries (TICA). RESULTS: Of 74 screened children, 60 met the inclusion/exclusion criteria (62% female; mean age 10+/-4 years). Baseline characteristics did not differ between the cases and controls, except hemoglobin (Hb) which was significantly lower in the SCD group (P<0.001). The right MCA TAMM (Time Averaged Maximum Mean) was significantly higher than in controls (125+5.52 cm/s vs. 92.5+1.63 cm/s, P<0.001). Left MCA did not show differences. The TICA TAMM was also different between cases and controls (P<0.05). CONCLUSIONS: Among Iranian children with asymptomatic SCD and without receiving recent transfusion TCD velocities are higher as compared to healthy controls but appear much lower than those observed in STOP (Stroke Prevention Trial in Sickle Cell Anemia) studies. We hypothesize that some children at high risk may be present with velocities lower than 170-200 cm/s thresholds. A prospective validation of ethnicity-specific prognostic criteria is warranted.
Ambulatory Care Facilities ; Anemia, Sickle Cell* ; Blood Transfusion ; Carotid Artery, Internal ; Child* ; Female ; Haplotypes ; Humans ; Prospective Studies ; Stroke ; Ultrasonography

Background: and Purpose Although onset-to-treatment time is associated with early clinical recovery in acute ischemic stroke (AIS) patients treated with intravenous tissue plasminogen activator (tPA), the effect of the timing of tPA-induced recanalization on functional outcomes remains debatable. Methods: We conducted a multicenter, prospective observational cohort study to determine whether early (within 1-hour from tPA-bolus) complete or partial recanalization assessed during 2-hour real-time transcranial Doppler monitoring is associated with improved outcomes in patients with proximal occlusions. Outcome events included dramatic clinical recovery (DCR) within 2 and 24-hours from tPA-bolus, 3-month mortality, favorable functional outcome (FFO) and functional independence (FI) defined as modified Rankin Scale (mRS) scores of 0–1 and 0–2 respectively. Results: We enrolled 480 AIS patients (mean age 66±15 years, 60% men, baseline National Institutes of Health Stroke Scale score 15). Patients with early recanalization (53%) had significantly (P<0.001) higher rates of DCR at 2-hour (54% vs. 10%) and 24-hour (63% vs. 22%), 3-month FFO (67% vs. 28%) and FI (81% vs. 39%). Three-month mortality rates (6% vs. 17%) and distribution of 3-month mRS scores were significantly lower in the early recanalization group. After adjusting for potential confounders, early recanalization was independently associated with higher odds of 3-month FFO (odds ratio [OR], 6.19; 95% confidence interval [CI], 3.88 to 9.88) and lower likelihood of 3-month mortality (OR, 0.34; 95% CI, 0.17 to 0.67). Onset to treatment time correlated to the elapsed time between tPA-bolus and recanalization (unstandardized linear regression coefficient, 0.13; 95% CI, 0.06 to 0.19). Conclusions Earlier tPA treatment after stroke onset is associated with faster tPA-induced recanalization. Earlier onset-to-recanalization time results in improved functional recovery and survival in AIS patients with proximal intracranial occlusions.