Abstract W MP7: Predictors and Implications of Capacity to Provide Informed Consent for Acute Ischemic Stroke Treatment Trials

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Hari Kishan R Indupuru ◽  
Loren Shen ◽  
Amber N Jacobs ◽  
Chunyan Cai ◽  
James C Grotta ◽  
...  

Background and objectives: Enrollment into AIS trials has always been limited by the ability of the patient to give informed consent or the availability of a Legally Authorized Representative (LAR) in decision making capacity on behalf of the patient. In this analysis we try to identify the factors contributing to an acute ischemic stroke (AIS) patient’s inability to give informed consent. We hypothesized that clinical features and demographics would differ between those patients with and without capacity to consent. Methods: This analysis includes patients who enrolled into the coordinating center of the prospective, randomized ARTSS-2 clinical trial (Argatroban + TPA for acute ischemic stroke) and also screen failures due to inability to consent. Data is collected prospectively in the study screening log. The data collected included age, gender, race, NIHSS, lesion location, ER arrival time and mode of consent (self-consent, LAR-consent and unable to consent). Results: Between 12/11 and 06/13, a total of 33 acute ischemic stroke patients received IV-tPA and were eligible for the ARTSS-2 study. While 19 were enrolled, 14/33 (42.4%) were otherwise eligible, but not enrolled due to inability to self-consent and no LAR present. Patients not enrolled due to lack of capacity to consent and without LAR present tended to have higher median NIHSS scores and greater proportions of drowsiness and aphasia compared to the other groups (see table). Conclusion: Approximately 2 in 5 AIS patients are not eligible for AIS clinical trials based solely on their lack of capacity for informed consent. It is remains ethically imperative that current clinical trials as well as future study designs address this disregarded group of patients who deserve the right to be able to participate in research. Addressing this group of patients through exception from informed consent (EFIC) will both extend research to all stroke patients, but also greatly enhance AIS research.

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
RAJAN R GADHIA ◽  
Farhaan S Vahidy ◽  
Tariq Nisar ◽  
Destiny Hooper ◽  
David Chiu ◽  
...  

Objective: Most acute stroke treatment trials exclude patients above the age of 80. Given the clear benefit of revascularization with intravenous tissue plasminogen activator (IV tPA) and mechanical thrombectomy (MT), we sought to assess functional outcomes in patients treated above the age of 80. Methods: We conducted a review of all patients admitted to Houston Methodist Hospital between January 2019 and August 2020 with an acute ischemic stroke (AIS) presentation[MOU1] for whom premorbid, discharge, and 90 day modified Rankin Scale scores were available. Patients were categorized by acute stroke treatment (IV tPA, MT, both or none[MOU2] ). mRS values were assessed during admission prior to discharge and at 90 days post stroke event. A delta mRS (Discharge vs. 90-day [MOU3] ) was defined and grouped as no change, improved, or worsened to assess overall functional disability in regards to the index stroke presentation. Results: A total of 865 patients with AIS presentation were included, of whom 651 (75.3%) were <80 years and 214 (24.7%) were > 80 years of age at presentation. A total of 208 patients received IV tPA, 176 underwent revascularization with MT only, 71 had both treatments, and 552 had no acute intervention. In patients >80 yrs who had no acute stroke intervention. mRS improvement was noted in 71.4% compared to 54.1% observed in those patients <80 years. Among patients who received IV tPA, 81.5% of > 80 years improved vs. 61.6% in the younger cohort. A similar trend was noted in the MT and combined treatment groups (76.2% vs. 71.2% and 78.6% vs. 79.3%, respectively). Conclusion: Based on our cohort of acute stroke patients, there was no significant difference in outcomes (as measured by delta mRS) for octogenarians and nonagenarians when compared to younger patients. There was a trend towards improvement in the elderly patients. Chronological age by itself may be an insufficient predictor of functional outcome among stroke patients and age cutoffs for enrollment of patients in acute stroke trials may need additional considerations.


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Janhavi M Modak ◽  
Syed Daniyal Asad ◽  
Jussie Lima ◽  
Amre Nouh ◽  
Ilene Staff ◽  
...  

Introduction: Acute ischemic stroke treatment has undergone a paradigm shift, with patients being treated in the extended time window (6-24 hours post symptom onset). The purpose of this study is to assess outcomes in stroke patients above 80 years of age undergoing endovascular treatment (EVT) in the extended time window. Methods: Acute ischemic stroke patients presenting to Hartford Hospital between January 2017 to June 2019 were considered for the study. Stroke outcomes in patients above 80 years of age with anterior circulation ischemic strokes presenting in the extended time window (Group A, n=30) were compared to a younger cohort of patients below 80 years (Group B, n=31). Patients over 80 years treated in the traditional time window (within 6 hours of symptom onset) served as a second set of controls (Group C, n=40). Statistical analysis was performed with a significance level of 0.05 Results: For angiographic results, there were no statistically significant differences in terms of good outcomes (TICI 2b-3) among patients of Group A, when compared to Groups B or C (p>0.05). For the endovascular procedures, no significant differences were noted in the total fluoroscopy time (Median Group A 44.05, Group B 38.1, Group C 35.25 min), total intra-procedure time (Median Group A 144, Group B 143, Group C 126 min) or total radiation exposure (Median Group A 8308, Group B 8960, Group C 8318 uGy-m 2 ). For stroke outcomes, a good clinical outcome was defined as modified Rankin score of 0-2 at discharge. Significantly better outcomes were noted in the younger patients in Group B - 35.4%, when compared to 13.3% in Group A (p=0.03). Comparative outcomes differed in the elderly patients above 80 years, Group A -13.3% vs Group C - 25%, although not statistically significant (p=0.23). There was a significant difference in mortality in patients of Group A - 40% as compared to 12% in the younger cohort, Group B (p= 0.01). Conclusions: In the extended time window, patients above 80 years of age were noted to have a higher mortality, morbidity compared to the younger cohort of patients. No significant differences were noted in the stroke outcomes in patients above 80 years of age when comparing the traditional and the extended time window for stroke treatment.


2020 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Adnan I. Qureshi ◽  
Hunain Aslam ◽  
Werdah Zafar ◽  
Wei Huang ◽  
Iryna Lobanova ◽  
...  

2008 ◽  
Vol 51 (4) ◽  
pp. 532
Author(s):  
A.M. Hoff ◽  
A.S. Yassa ◽  
M.F. Bellolio ◽  
L. Vaidyanathan ◽  
R. Kashyap ◽  
...  

Neurosurgery ◽  
2019 ◽  
Vol 85 (suppl_1) ◽  
pp. S47-S51
Author(s):  
Kimberly P Kicielinski ◽  
Christopher S Ogilvy

Abstract As ischemic stroke care advances with more patients eligible for mechanical thrombectomy, so too does the role of the neurosurgeon in these patients. Neurosurgeons are an important member of the team from triage through the intensive care unit. This paper explores current research and insights on the contributions of neurosurgeons in care of acute ischemic stroke patients in the acute setting.


2019 ◽  
Vol 39 (12) ◽  
pp. 2536-2538 ◽  
Author(s):  
Jinwei Pang ◽  
John H Zhang ◽  
Yong Jiang

Successful recanalization of the occluded vessel as early as possible has been widely accepted as the key principle of acute ischemic stroke (AIS) treatment. Unfortunately, for many years, the vast majority of AIS patients were prevented from receiving effective recanalization therapy because of a narrow therapeutic window. Recently, a series of inspiring clinical trials have indicated that more patients may benefit from delayed recanalization during an expanded therapeutic window, even up to 24 h after symptom onset. However, could potentially salvageable brain tissue (penumbra) in patients who do not receive medication within 24 h still possible to be saved?


Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Jay Chol Choi ◽  
Renee Y Hsia ◽  
Anthony S Kim

Background: The regional availability of hospitals with expertise in applying endovascular therapy for acute ischemic stroke is critical to ongoing efforts to develop effective interventions for this time-sensitive indication. We sought to assess the geographic proximity of stroke patients in California to centers that perform endovascular stroke therapy. Methods: We identified all hospitalizations for ischemic stroke at all 366 non-federal acute care hospitals in California from 2009 to 2010, including the subset where endovascular stroke therapy was employed, using data from the Office of Statewide Health Planning and Development. ZIP code centroids were used to estimate the geographic distance between a treating hospital and the patient’s residence. Using these distances, we estimated the proportion of stroke patients that lived within 2-hour (65 mile) transport distance to a hospital that performed certain threshold volumes of endovascular stroke cases each year. Results: From 2009-10, endovascular stroke treatment was used in 643 of 104,350 (0.6%) hospital discharges for ischemic stroke in California. A majority (60%) of these procedures were performed at hospitals that performed at least 12 procedures per year, and 83% of these procedures were performed at hospitals that performed at least 6 procedures per year. Of the 366 hospitals, 54 (15%) performed at least one endovascular stroke procedure per year. The median number of procedures per hospital per year was 3.5 (IQR 1-9). In-hospital mortality for endovascular stroke therapy was 21%, and a higher procedural volume at the hospital level was not associated with lower mortality. Most (86%) stroke patients lived within 65 miles of a center that performed at least 6 procedures per year (median with IQR, 9.5[7-17]), and 97% were within 65 miles of a center that performed at least 1 procedure per year. Conclusion: In 2009-10, less than 1% of ischemic stroke hospitalizations in California involved the use of endovascular stroke therapy. Most patients lived within a 2-hour transport distance from a center that performed at least one endovascular procedure per year.


Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Xin Tong ◽  
Sallyann Coleman King ◽  
Erika Odom ◽  
Quanhe Yang

Introduction: Studies suggest a significant reduction in emergency department visits and hospitalizations for acute ischemic stroke (AIS) during the COVID-19 pandemic in the United States. Few studies have examined AIS hospitalizations, treatments, and outcomes during the pandemic period. The present study compared the demographic and clinical characteristics of patients hospitalized with AIS before and during the COVID-19 pandemic (weeks 11-24 in 2019 vs. 2020). Method: We identified 42,371 admissions with a clinical diagnosis of AIS, from 370 participating hospitals who contributed data during weeks 11-24 in both 2019 and 2020 to the Paul Coverdell National Acute Stroke Program (PCNASP). Results: During weeks 11-24 of the COVID-19 period, AIS hospitalizations declined by 24.5% compared to the same period in 2019 (18,233 in 2020 vs. 24,138 in 2019). In 2020, the percentage of individuals aged <65 years who were hospitalized with AIS was higher compared with the same period in 2019 (34.6% vs. 32.7%, p<0.001); arriving by EMS were higher in 2020 compared with 2019 (47.7% vs. 44.8%, p<0.001). Individuals admitted with AIS in 2020 had a higher mean National Institutes of Health Stroke Scale (NIHSS) score compared with 2019 (6.7 vs. 6.3, p<0.001). In 2020, the in-hospital death rates increased by 16% compared to 2019 (5.0% vs. 4.3%, p<0.001). However, there were no differences in rates of alteplase use, achievement of door to needle in 60 minutes, or complications from reperfusion therapy between the two time periods. Conclusion: A higher percentage of younger (<65 years) individuals and more severe AIS cases were admitted to the participating hospitals during weeks 11 to 24 of the COVID-19 pandemic in 2020 compared to the same period in 2019. The AIS in-hospital death rate increased 16% during the pandemic weeks as compared to the same weeks in 2019. Additional studies are needed to examine the impacts of the COVID-19 pandemic on stroke treatment and outcomes.


Sign in / Sign up

Export Citation Format

Share Document