Effect of Danhong injection on neurological recovery and adverse events in patients with acute ischemic stroke

Objectives To evaluate the effectiveness and safety of the combination of beraprost sodium (BPS) and aspirin in patients with acute ischemic stroke (AIS). Methods There were 384 patients with AIS enrolled in this single-center, retrospective study. The BPS group comprised patients who received combination therapy with BPS and aspirin, and the control group comprised those who received only aspirin. Primary measurements were glomerular filtration rate (GFR), cystatin-c (Cys-C), National Institute of Health Stroke Scale (NIHSS) score, modified activities of daily living index (MBI), modified Rankin scale (mRS), and blood coagulation indexes. Recurrence and adverse events were recorded. Results There were no significant differences in patient characteristics at baseline between the two groups. GFR and Cys-C levels increased in the BPS group compared with the control group. After treatment, the NIHSS and mRS score were significantly lower in the BPS group compared with the control group, whereas the MBI scores were significantly higher in the BPS group compared with the control group. There was no significant difference in blood coagulation between the two groups. There were no serious adverse events in either group. Conclusions Combination therapy with BPS and aspirin may be a safe and effective treatment for AIS.

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Thrombectomy of calcified emboli in stroke. Does histology of thrombi influence the effectiveness of thrombectomy?

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2017-013226 ◽

2017 ◽

Vol 10 (4) ◽

pp. 345-350 ◽

Cited By ~ 32

Author(s):

Tomas Dobrocky ◽

Eike Piechowiak ◽

Alessandro Cianfoni ◽

Felix Zibold ◽

Luca Roccatagliata ◽

...

Keyword(s):

Mechanical Properties ◽

Ischemic Stroke ◽

Clinical Practice ◽

Adverse Events ◽

Acute Ischemic Stroke ◽

Endovascular Therapy ◽

Stent Retriever ◽

Complication Rates ◽

Peripheral Vessel ◽

Stent Retrievers

Background and purposeThrombus composition has been postulated to affect the success of endovascular therapy. Calcified clots are composed of large amounts of calcium phosphate which influences their mechanical properties and may serve as a model for testing this hypothesis. The aim of this study was to evaluate the recanalization and complication rates of calcified thromboemboli in patients with acute ischemic stroke who underwent thrombectomy.Material and methodsA retrospective analysis was performed of all calcified intracranial thromboemboli in patients suffering an acute ischemic stroke, referred for endovascular therapy at two centers between January 2013 and July 2016.ResultsEight patients with a calcified intracranial clot underwent stent retriever thrombectomy (five women; mean age 80 years). Mean clot attenuation was 305 HU (range 150–640 HU). Successful reperfusion defined, as Thrombolysis in Cerebral Infarction grade 2b–3 was achieved in only one patient (12.5%). Two periprocedural adverse events occurred: one peripheral vessel perforation which was coiled and one inadvertent stent retriever detachment due to fracture of the stent retriever wire.ConclusionStent retriever thrombectomy of calcified thromboemboli seems less effective than with other types of clots. Different mechanical properties of calcified clots may render them stiffer and less accessible for stent retrievers. When faced with a calcified intracranial thromboembolus in clinical practice, a more contained approach may be warranted in view of low recanalization rates, and the potential for periprocedural adverse events.

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Remote Ischemic Conditioning With Exercise (RICE)—Rehabilitative Strategy in Patients With Acute Ischemic Stroke: Rationale, Design, and Protocol for a Randomized Controlled Study

Frontiers in Neurology ◽

10.3389/fneur.2021.654669 ◽

2021 ◽

Vol 12 ◽

Author(s):

Zhenzhen Han ◽

Wenbo Zhao ◽

Hangil Lee ◽

Melissa Wills ◽

Yanna Tong ◽

...

Keyword(s):

Ischemic Stroke ◽

Adverse Events ◽

Acute Ischemic Stroke ◽

Infarct Volume ◽

Controlled Trial ◽

Walking Ability ◽

Remote Ischemic Conditioning ◽

Ischemic Conditioning ◽

Randomized Controlled ◽

Symptom Exacerbation

Objective: Exercise rehabilitation is an effective therapy in reducing the disability rate after stroke and should be carried out as early as possible. However, very early rehabilitation exercise exacerbates brain injury and is difficult to conduct in stroke patients due to their weakened and potentially disabled state. It is valuable to explore additional early rehabilitation strategies. Remote Ischemic Conditioning (RIC) is a novel therapy designed to protect vital organs from severe lethal ischemic injury by transient sublethal blood flow to non-vital organs, including the distal limbs, in order to induce endogenous protection. RIC has previously been conducted post-stroke for neuroprotection. However, whether combined early RIC and exercise (RICE) therapy enhances stroke rehabilitation remains to be determined.Methods: This is a single-center, double-blinded, randomized controlled trial that will enroll acute ischemic stroke patients within 24 h of symptom onset or symptom exacerbation. All enrolled patients will be randomly assigned to either the RICE group (exercise with RIC) or the control group (exercise with sham RIC) at a ratio of 1:1, with 20 patients in each group. Both groups will receive RIC or sham RIC within 24 h after stroke onset or symptom exacerbation, once a day, for 14 days. All patients will begin exercise training on the fourth day, twice a day, for 11 days. Their neurological function [Modified Rankin Scale (mRS) score, National Institutes of Health Stroke Scale (NIHSS) score, Barthel Index, and walking ability], infarct volume (nuclear magnetic resonance, MRI), and adverse events will be evaluated at different time points in their post-stroke care.Results: The primary outcome is safety, measured by the incidence of any serious RICE-related adverse events and decreased adverse events during hospitalization. The secondary outcome is a favorable prognosis within 90 days (mRS score < 2), determined by improvements in the mRS score, NIHSS score, Barthel Index, walking ability after 90 days, and infarct volume after 12 ± 2 days.Conclusion: This study is a prospective randomized controlled trial to determine the rehabilitative effect of early RIC followed by exercise on patients with acute ischemic stroke.Trial Registration:www.chictr.org.cn, identifier: ChiCTR2000041042

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Abstract T P72: Baseline Variables Have Little Influence on Early Change in Neurological Status (ΔNIHSS) After Acute Ischemic Stroke: Basis For a Genetic Study

Stroke ◽

10.1161/str.46.suppl_1.tp72 ◽

2015 ◽

Vol 46 (suppl_1) ◽

Author(s):

Laura Heitsch ◽

Carlos Cruchaga ◽

Naim Khoury ◽

Rebecca Weisenhan ◽

Ford L Andria ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Neurological Status ◽

Neurological Recovery ◽

Neurological Deficits ◽

Dramatic Improvement ◽

Scale Scores ◽

Multivariable Regression ◽

Jewish Hospital ◽

The Difference

Introduction: Neurological deficits can be highly unstable within the first 24 hours after acute ischemic stroke (AIS), with some patients showing dramatic improvement while others rapidly deteriorate. We are interested in genetic influences on early neurological recovery/deterioration. Here, we characterize NIHSS changes within the first 24 hours after stoke onset (ΔNIHSS) in a large cohort to determine baseline clinical variables that influence this outcome measure. Methods: AIS patients presenting to two sites (Barnes-Jewish Hospital, St Louis and Vall D’Hebron Hospital Barcelona) between 2008-2013 were prospectively enrolled. Baseline NIHSS was collected within 6 hours and again at 24 hours after symptom onset. ΔNIHSS was calculated as the difference in these stroke scale scores. Demographics, baseline comorbidities and medications, as well as acute treatment variables were recorded for each subject. Stepwise multivariable regression (SAS) was used to determine variables that significantly influence ΔNIHSS. Results: There were 954 patients enrolled (St Louis = 433, Barcelona = 521). Table 1 demonstrates the frequencies and means (SD) of the baseline variables. ΔNIHSS follows a normal distribution (figure). All baseline variables listed in table 1 were analyzed for influence on ΔNIHSS. Only baseline NIHSS (R2 = 0.0597, p<0.0001), baseline glucose (R2 = 0.0176, p=<0.0001,) and age (R2 = 0.0106, p=0.0011) independently influenced ΔNIHSS, accounting for only 8.79% of the variance. Conclusion: Baseline variables (NIHSS, glucose and age) modestly influence early neurological recovery/deterioration. However, 91% of ΔNIHSS variability remains unexplained, suggesting that other factors such as genetics, could play an important role in early outcomes following AIS. A GWAS of ΔNIHSS is currently underway.

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Abstract P148: Safety And Efficacy Of Edaravone Dexborneol Versus Edaravone Alone For The Treatment Of Acute Ischemic Stroke Patients With Hypertention: Analysis From Taste Trial

Hypertension ◽

10.1161/hyp.78.suppl_1.p148 ◽

2021 ◽

Vol 78 (Suppl_1) ◽

Author(s):

Jie Xu ◽

Yongjun Wang

Keyword(s):

Ischemic Stroke ◽

Adverse Events ◽

Acute Ischemic Stroke ◽

Medical History ◽

Functional Outcomes ◽

Group Versus ◽

Phase Iii ◽

Secondary Outcome ◽

Serious Adverse Events ◽

Intention To Treat

Background and Aims: Evidenced by TASTE phase III trial, 90-day good functional outcomes favored the edaravone dexborneol group versus edaravone group when administered within 48 hours after Acute Ischemic Stroke (AIS). The present study aimed to investigate the effects of edaravone dexborneol versus edaravone in AIS patients with hypertension medical history. Methods: This study was a subgroup analysis of the TASTE trial with hypertension medical history. The primary outcome was the proportion of patients with modified Rankin Scale (mRS) score ≤1 on day 90 after randomization. The secondary outcome was the mRS score on day 90. The safety endpoints were the incidences of adverse events, serious adverse events and deaths. Analyses were by intention to treat. Results: We included 767 AIS patients with hypertension (390 in edaravone dexborneol group, 377 in edaravone group) in this analysis. Among them, 252 (64.62%) in edaravone dexborneol group versus 199 (52.79%) in edaravone group reached mRS score ≤1 on D90, revealing significantly higher proportion of mRS score ≤1 on D90 in edaravone dexborneol group (OR 1.63 [95% CI, 1.22-2.18]; P<0.001). Significant differences occurred between two groups in mRS score on D90 ([OR 1.32 [95% CI, 1.02-1.72]; P=0.038). The safety outcomes indicated that the two groups were similar in incidences of adverse events (366 [93.85%] versus 352 [93.37%], p=0.787), serious adverse events (48 [12.31%] versus 34 [9.02%], p=0.1405) and number of deaths (6 [1.54%] versus 4 [1.06%], p=0.56). Conclusion: This analysis demonstrated that AIS patients with hypertension receiving edaravone dexborneol had better functional outcomes than those with edaravone, which provided evidences for the clinical application of edaravone dexborneol in AIS patients with hypertension. Keywords: Edaravone dexborneol, Acute ischemic stroke, Hypertension, mRS score

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Natalizumab in acute ischemic stroke (ACTION II)

Neurology ◽

10.1212/wnl.0000000000010038 ◽

2020 ◽

Vol 95 (8) ◽

pp. e1091-e1104 ◽

Cited By ~ 1

Author(s):

Mitchell S.V. Elkind ◽

Roland Veltkamp ◽

Joan Montaner ◽

S. Claiborne Johnston ◽

Aneesh B. Singhal ◽

...

Keyword(s):

Ischemic Stroke ◽

Adverse Events ◽

Acute Ischemic Stroke ◽

Serious Adverse Events ◽

Double Blind ◽

Excellent Outcome ◽

Scale Scores ◽

To Receive ◽

Improve Patient

ObjectiveWe evaluated the effect of 2 doses of natalizumab on functional outcomes in patients with acute ischemic stroke (AIS).MethodsIn this double-blind phase 2b trial, patients with AIS aged 18–80 years with NIH Stroke Scale scores of 5–23 from 53 US and European sites were randomized 1:1:1 to receive a single dose of 300 or 600 mg IV natalizumab or placebo, with randomization stratified by treatment window (≤9 or >9 to ≤24 hours from patient's last known normal state). The primary endpoint was a composite measure of excellent outcome (modified Rankin Scale score ≤1 and Barthel Index score ≥95) at day 90 assessed in all patients receiving a full dose. Sample size was estimated from a Bayesian model; p values were not used for hypothesis testing.ResultsAn excellent outcome was less likely with natalizumab than with placebo (natalizumab 300 or 600 mg odds ratio 0.60; 95% confidence interval 0.39–0.93). There was no effect modification by time to treatment or use of thrombolysis/thrombectomy. For natalizumab 300 mg, 600 mg, or placebo, there were no differences in incidence of adverse events (90.0%, 92.1%, and 92.3%, respectively), serious adverse events (25.6%, 32.6%, and 20.9%, respectively), or deaths (6.7%, 4.5%, and 5.5%, respectively).ConclusionsNatalizumab administered ≤24 hours after AIS did not improve patient outcomes.ClinicalTrials.gov identifierNCT02730455Classification of evidenceThis study provides Class I evidence that for patients with AIS, an excellent outcome was less likely in patients treated with natalizumab than with placebo.

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Neurological recovery after acute ischemic stroke with obstructive sleep apnea

Acta Neurologica Scandinavica ◽

10.1111/ane.12868 ◽

2018 ◽

Vol 137 (2) ◽

pp. 283-283

Author(s):

T. Kawada

Keyword(s):

Obstructive Sleep Apnea ◽

Ischemic Stroke ◽

Sleep Apnea ◽

Acute Ischemic Stroke ◽

Neurological Recovery ◽

Obstructive Sleep

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

Stroke ◽

10.1161/strokeaha.120.033425 ◽

2021 ◽

Author(s):

Iris Lettow ◽

Märit Jensen ◽

Eckhard Schlemm ◽

Florent Boutitie ◽

Fanny Quandt ◽

...

Keyword(s):

Regression Analysis ◽

Ischemic Stroke ◽

Adverse Events ◽

Acute Ischemic Stroke ◽

Functional Outcome ◽

Fatal Outcome ◽

Modified Rankin Scale ◽

Unique Identifier ◽

Serious Adverse Events ◽

Link Type

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. In clinical trials, severe complications are recorded as serious adverse events (SAE). We analyzed the effect of SAE on functional outcome and predictors of SAE in the randomized controlled WAKE-UP trial (Efficacy and Safety of MRI-Based Thrombolysis in Wake-Up Stroke). Methods: We performed a post hoc analysis of WAKE-UP, a multicenter, randomized, placebo-controlled clinical trial of magnetic resonance imaging-guided intravenous thrombolysis with alteplase in patients with acute ischemic stroke and unknown time of onset. Functional outcome was assessed by the modified Rankin Scale 90 days after the stroke. SAE were reported to a central safety desk and recorded and categorized by organ system using Medical Dictionary for Regulatory Activities terminology. We used logistic regression analysis to determine the effect of SAE on functional outcome and linear multiple regression analysis to identify baseline predictors of SAE. Results: Among 503 patients randomized, 199 SAE were reported for n=110 (22%) patients. Of those patients who did suffer a SAE, 20 (10%) had a fatal outcome. Patients suffering from at least one SAE had a lower odds of reaching a favorable outcome (modified Rankin Scale score of 0–1) at 90 days (adjusted odds ratio, 0.36 [95% CI, 0.21–0.61], P <0.001). Higher age ( P =0.04) and male sex ( P =0.01) were predictors for the occurrence of SAE. Conclusions: SAEs were observed in about one in 5 patients, were more frequent in elderly and male patients and were associated with worse functional outcome. These results may help to assess the risk of SAE in future stroke trials and create awareness for severe complications after stroke in clinical practice. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01525290 and https://eudract.ema.europa.eu ; Unique identifier: 2011-005906-32.

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1149 A Pilot Quality Improvement (QI) Study To Assess Whether Bilevel Positive Airway Pressure (bipap) Support In Acute Ischemic Stroke Patients With Sleep Disordered Breathing, Can Improve Neurological Recovery During Acute Stroke Care

SLEEP ◽

10.1093/sleep/zsaa056.1143 ◽

2020 ◽

Vol 43 (Supplement_1) ◽

pp. A438-A438

Author(s):

A N Nadhim ◽

J wong ◽

D Gupta ◽

L Suhan ◽

M Siegel ◽

...

Keyword(s):

Quality Improvement ◽

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Stroke Unit ◽

Adverse Outcomes ◽

Neurological Recovery ◽

Case Group ◽

Mean Flow ◽

Bilevel Positive Airway Pressure ◽

Obstructive Sleep

Abstract Introduction Obstructive sleep apnea (OSA) has been associated with adverse outcomes in patients with stroke. While data is limited, it suggests that treatment of OSA may improve neurological recovery. With this quality improvement (QI) project, we aim to develop an interprofessional-team workflow process for screening and correction of OSA in acute ischemic stroke, with the goal to improve outcomes of neurological recovery. Methods This is an ongoing study to screen all eligible patients admitted to JFK Medical Center stroke unit, with MRI-proven Supratentorial acute ischemic stroke. The patients are screened using an overnight Pulse Oximetry test. A 3% oxygen desaturation index (ODI) of ≥10/hr or 4% ODI of ≥ 5/hr is considered at high risk for OSA. Such Patients will receive nocturnal Auto-adjusting BIPAP therapy during their acute care stay, for up to 5 days, for at least 4 hours per night. Eligible Patients who refused BiPAP therapy or were non-compliant will be considered as a controls. Baseline NIH stroke scale (NIHSS), and bilateral MCA mean flow velocity (MFV) in the morning, by transcranial doppler (TCD) will be assessed at baseline for cases and controls, and after BiPAP therapy, for the case group. The two groups of patients will also be compared in terms of Modified Rankin Scale at time of discharge and at phone follow-up after 6 weeks. Results Between Oct 17th, 2019 to current, 15 patients were admitted to the stroke unit with MRI confirmed stroke. Ages ranged from 34 - 88 years (average age 66.5 years). 8 patients (60%) were female. Of those, 6 patients consented to being screened for OSA. Of these, 1 had 4%ODI >5/hr, and therefore received treatment with BIPAP. However, compliance was < 4 hrs on 2 consecutive nights. Conclusion This is ongoing QI project and results will be available after few more months of continued recruitment. Support Auto-adjusting BIPAP machines were provided by RESMED.

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