Abstract P2: Results of a Prospective Observational Cohort Study of Tenecteplase as Standard of Care Stroke Thrombolytic

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Steven J Warach ◽  
Jefferson T Miley ◽  
Manzure Mawla ◽  
Samantha Miller ◽  
Ming-Chieh Ding ◽  
...  

Background: Our 10-hospital network (2 CSCs, 2PSCs, 6 non-SCs) switched our standard stroke thrombolytic from alteplase (ALT) to tenecteplase (TNK; 0.25 mg/kg) in September 2019. Methods: We designed a two-year prospective cohort analysis of key processes and clinical outcomes for TNK-treated patients with planned quarterly assessments of feasibility and safety. The TNK cohort is compared to the retrospective historical cohort of all unique patients at these hospitals treated with ALT during the prior 2-year period (n=354). Analysis were taken from a local REDcap registry that recorded data fields required for Stroke Center certification and submission to Get-With-The Guidelines (GWTG). Interim results through three quarters ending June 30, 2020. Results: 151 patients were treated with TNK. The samples TNK v ALT were well matched on age (median, IQR) 66.0 (55.0, 76.0) v 67.0 (55.0, 78.8) and NIHSS at admission (median, IQR), 8 (4, 13) v 8 (4, 15). Symptomatic ICH (ECASS 3 definition) occurred in 2.0% of TNK and 2.3% of ALT treated patients; all but one symptomatic ICH occurred in patients treated with both thrombolytic and endovascular therapies. All cause in-hospital mortality was 3.3% and 6.8%, respectively. No differences were observed in early outcomes of discharge to home (52%, 53%) or independent ambulation (46%, 45%). Day 90 Rankin Score (last observation carried forward for missing values) was available only for TNK: mRS 0-1 in 46.4% (95%CI 38.6%-54.3%), 0-2 in 55.6% (95%CI 47.7%-63.3%). A significantly greater proportion of patients were treated with the lytic within 45 minutes of hospital arrival after the switch to TNK using Get-With-The-Guidelines DTN time criteria (Table), most notably at the primary stroke centers. Conclusions: To date, the transition to TNK was associated with reductions in DTN times and in Drip-and-Ship transfer times (see related abstract). No differences were seen on early indices of safety or efficacy.

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Cortlyn J Elshire ◽  
Lindsay Olson-Mack ◽  
Jean Rockwell ◽  
Sara Deskin ◽  
Lynn Berger ◽  
...  

Introduction: American Stroke Association guidelines recommend pre-hospital stroke code notification via EMS to facilitate prompt treatment decision for acute ischemic stroke (AIS) patients. Despite pre-notification to the stroke team, treatment decisions are often delayed until medical history and last known well times are established. Hypothesis: We hypothesized that screening for IV Alteplase candidacy and obtaining pertinent medical history from a witness or patient during a pre-hospital stroke code activation prior to hospital arrival would decrease door to needle (DTN) times. Methods: A retrospective analysis was conducted on 193 patients presenting to the emergency department (ED) at a Comprehensive Stroke Center (CSC) from February 2016 through July 2016. A process improvement (PI) event was initiated between the CSC and two fire stations with a catchment time of > 10 minutes. For pre-hospital activated stroke codes, the witness or patient was provided the contact card and encouraged to call the centralized number to the Neurologist. Inclusion criteria: All patients presenting to the ED with EMS pre-hospital stroke code activation. Exclusion criteria: Patients presenting to the ED with stroke code initiated after arrival, or medic response events which did not lead to a pre-hospital stroke code activation. Results: After applying criteria, 126 met inclusion and exclusion criteria. A total of 19 patients arrived via the 2 fire stations with pre-hospital stroke code initiations and serve as our intervention group, while 107 patients underwent standard of care. Contact cards were provided to 11 patients (58%) in the intervention group prior to arrival. IV Alteplase was initiated for 3 of 11 patients (27.3%) in the intervention group vs. 19 of 107 patients (17.8%) in the standard of care group. Mean and median DTN times in the intervention group was 36 minutes as compared to a mean of 46.1 minutes and median time of 40 minutes receiving standard of care. Conclusions: Preliminary data suggest that DTN times can be decreased when medical history is obtained prior to hospital arrival to screen for IV Alteplase eligibility. This study warrants further investigation in pre-acquisition of history for pre-hospital stroke code patients.


2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S61-S61 ◽  
Author(s):  
Ryan Dare ◽  
Kelsey McCain ◽  
Katherine Lusardi ◽  
Kay Daniels ◽  
Jacob Painter ◽  
...  

Abstract Background Molecular-based automated systems for the rapid diagnosis of bacterial infections have potential to improve patient care. The Accelerate Pheno™ blood culture detection system (ACCEL) is an FDA approved platform that allows for identification (ID) and antimicrobial susceptibility testing (AST) 8 hours following growth in routine culture. Methods This is a single-center retrospective chart review of bacteremic adult inpatients before and after implementation of ACCEL. Laboratory and clinical data were collected February–March 2018 (intervention) and compared with a January–April 2017 historical cohort (standard of care). Standard of care ID and AST were performed using VITEK® MS (MALDI-TOF MS) and VITEK®2, respectively. An active antimicrobial stewardship program was in place during both study periods. Patients with polymicrobial cultures, off-panel isolates, previous positive culture, or who were discharged prior to final AST report were excluded. Primary outcome was length of stay (LOS). Secondary outcomes were inpatient antibiotic duration of therapy (DOT) and time to optimal therapy (TTOT). Nonparametric unadjusted analyses were performed due to non-normal distributions. Statistics were performed using SAS 9.4. Results Of the 143 positive cultures performed on ACCEL during intervention, 118 (83%) were identified as on-panel organisms. Seventy-five (64%) of these 118 cultures and 79 (70%) of 113 reviewed standard of care cultures met inclusion criteria. Patient comorbidities (P = NS), MEWS severity score (P = 0.10), source of bacteremia (P = NS), and pathogen detected (P = 0.30) were similar between cohorts. Time from collection to ID (28.2 ± 12.7 hours vs. 53.8 ± 20.9 hours; P < 0.001) and AST (31.9 ± 11 hours vs. 71.8 ± 20 hours; P < 0.001) were shorter in the intervention arm. Conclusion Compared with standard of care, ACCEL shortens laboratory turn-around-time and improves clinical outcomes. The use of this system has resulted in decreased mean antibiotic DOT, TTOT, and LOS. Further studies are needed to verify these findings. Disclosures All authors: No reported disclosures.


2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Lisa Lindner ◽  
Anja Weiß ◽  
Andreas Reich ◽  
Siegfried Kindler ◽  
Frank Behrens ◽  
...  

Abstract Background Clinical data collection requires correct and complete data sets in order to perform correct statistical analysis and draw valid conclusions. While in randomized clinical trials much effort concentrates on data monitoring, this is rarely the case in observational studies- due to high numbers of cases and often-restricted resources. We have developed a valid and cost-effective monitoring tool, which can substantially contribute to an increased data quality in observational research. Methods An automated digital monitoring system for cohort studies developed by the German Rheumatism Research Centre (DRFZ) was tested within the disease register RABBIT-SpA, a longitudinal observational study including patients with axial spondyloarthritis and psoriatic arthritis. Physicians and patients complete electronic case report forms (eCRF) twice a year for up to 10 years. Automatic plausibility checks were implemented to verify all data after entry into the eCRF. To identify conflicts that cannot be found by this approach, all possible conflicts were compiled into a catalog. This “conflict catalog” was used to create queries, which are displayed as part of the eCRF. The proportion of queried eCRFs and responses were analyzed by descriptive methods. For the analysis of responses, the type of conflict was assigned to either a single conflict only (affecting individual items) or a conflict that required the entire eCRF to be queried. Results Data from 1883 patients was analyzed. A total of n = 3145 eCRFs submitted between baseline (T0) and T3 (12 months) had conflicts (40–64%). Fifty-six to 100% of the queries regarding eCRFs that were completely missing were answered. A mean of 1.4 to 2.4 single conflicts occurred per eCRF, of which 59–69% were answered. The most common missing values were CRP, ESR, Schober’s test, data on systemic glucocorticoid therapy, and presence of enthesitis. Conclusion Providing high data quality in large observational cohort studies is a major challenge, which requires careful monitoring. An automated monitoring process was successfully implemented and well accepted by the study centers. Two thirds of the queries were answered with new data. While conventional manual monitoring is resource-intensive and may itself create new sources of errors, automated processes are a convenient way to augment data quality.


2021 ◽  
pp. 089719002110212
Author(s):  
Brandy Williams ◽  
Justin Muklewicz ◽  
Taylor D. Steuber ◽  
April Williams ◽  
Jonathan Edwards

Background: Shifting inpatient antibiotic treatment to outpatient parenteral antimicrobial therapy may minimize treatment for acute bacterial skin and skin structure infections, including cellulitis. The purpose of this evaluation was to compare 30-day hospital readmission or admission due to cellulitis and economic outcomes of inpatient standard-of-care (SoC) management of acute uncomplicated cellulitis to outpatient oritavancin therapy. Methods: This retrospective, observational cohort study was conducted at a 941-bed community teaching hospital. Adult patients 18 years and older treated for acute uncomplicated cellulitis between February 2015 to December 2018 were eligible for inclusion. Information was obtained from hospital and billing department records. Patients were assigned to either inpatient SoC or outpatient oritavancin cohorts for comparison. Results: 1,549 patients were included in the study (1,348 in the inpatient SoC cohort and 201 in the outpatient oritavancin cohort). The average length of stay for patients admitted was 3.6 ± 1.5 days. The primary outcome of 30-day hospital readmission or admission due to cellulitis occurred in 49/1348 (3.6%) patients in the inpatient SoC cohort versus 1/201 (0.5%) in the outpatient oritavancin cohort (p = 0.02). The difference between costs and reimbursement was improved in the outpatient oritavancin group (p < 0.001). Conclusion: Outpatient oritavancin for acute uncomplicated cellulitis was associated with reduction in 30-day hospital readmissions or admissions compared to inpatient SoC. Beneficial economic outcomes for the outpatient oritavancin cohort were observed. Additional studies are required to confirm these findings.


2021 ◽  
Author(s):  
Amal ABOUDA ◽  
Yasmine BOUKHALFA ◽  
Wafa ANENE ◽  
Zied HAJJEJ ◽  
Ezzeddine GHAZOUANI ◽  
...  

Abstract Purpose: The aim of our study was to evaluate the prevalence of aPLAs among Tunisian critically-ill covid19 and non-covid19 patients and to investigate the clinical significance of aPLAs by determining the SOFA score and their respiratory failure during their ICU stay. Methods: We conducted a prospective observational cohort study including critically ill COVID-19 patients and non-COVID-19 patients with pulmonary origin sepsis, admitted to the intensive care unit. Blood samples were collected on days 1, 3, 5, 8 and 10 of hospitalization in order to measure titers of anti-cardiolipin (aCL), anti-phosphatidylserine (aPS) by chemiluminescence immunoassay. Results: We enrolled 43 COVID-19 patients and 31 non COVID-19 with pulmonary origin sepsis. In-hospital mortality rate was significantly higher (p=0.026) in COVID-19 patients (79%). 58.8% of COVID-19 patients were aPLA positive; however, only 22.5% of the non-COVID-19 were positive for aPLA (p=0.002). A significant positive correlation existed between respiratory SOFA component at days 3, 5, 8 and 10 and anti-phospholipid antibodies concentrations. Conclusion: Based on our results, for the first time, anti-phospholipid antibodies may be used as an independent indicator of respiratory organ failure in critically ill patients, to stratify and assess the prognosis of pulmonary origin sepsis and COVID-19.


2019 ◽  
Author(s):  
Charlotte Abrahamsen ◽  
Birgitte Nørgaard ◽  
Eva Draborg ◽  
Morten Frost Nielsen

Abstract Background: While orthogeriatric care to patients with hip fractures is established, the impact of similar intervention in patients with fragility fractures in general is lacking. Therefore, we aimed to assess the impact of an orthogeriatric intervention on postoperative complications and readmissions among patients admitted due to and surgically treated for fragility fractures. Methods: A prospective observational cohort study with a retrospective control was designed. A new orthogeriatric unit for acute patients of sixty-five years or older with fragility fractures in terms of hip, vertebral or appendicular fractures was opened on March 1, 2014. Patients were excluded if the fracture was cancer-related or caused by high-energy trauma, if the patient was operated on at another hospital, treated conservatively with no operation, or had been readmitted within the last month due to fracture-related complications. Results: We included 591 patients; 170 in the historical cohort and 421 in the orthogeriatric cohort. No significant differences were found between the two cohorts with regard to the proportion of participants experiencing complications (24.5% versus 28.3%, p = 0.36) or readmission within 30 days after discharge (14.1% vs 12.1%, p = 0.5). With both cohorts collapsed and adjusting for age, gender and CCI, the odds of having postoperative complications as a hip fracture patient was 4.45, compared to patients with an appendicular fracture (p < 0.001). Furthermore, patients with complications during admission were at a higher risk of readmission within 30 days than were patients without complications (22.3% vs 9.5%; p < 0.001). Conclusions: In older patients admitted with fragility fractures, our model of orthogeriatric care showed no significant differences regarding postoperative complications or readmissions compared to the traditional care. However, we found significantly higher odds of having postoperative complications among patients admitted with a hip fracture compared to other fragility fractures. Additionally, our study reveals an increased risk of being readmitted within 30 days for patients with postoperative complications.


Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Bijoy K Menon ◽  
Jeffrey L Saver ◽  
Mayank Goyal ◽  
Raul Noguiera ◽  
Shyam Prabhakaran ◽  
...  

Purpose: To determine hospital and patient level characteristics associated with use of endovascular therapy for acute ischemic stroke and to analyze trends in clinical outcome. Methods: Data were from Get With The Guidelines-Stroke hospitals from 4/1/2003 to 6/30/2013. We looked at secular trends in number of hospitals providing endovascular therapy, use of endovascular therapy in these hospitals, and clinical outcomes. We also analyzed hospital and patient characteristics associated with endovascular therapy utilization. Results: Of 1087 hospitals, 454 provided endovascular therapy to at least one patient in the study period. From 2003 to 2012, the proportion of hospitals providing endovascular therapy increased by 1.6%/year (from 12.9% to 28.9%), with a modest drop in 2013 to 23.4%. Use in these hospitals increased from 0.7% to 2% of all ischemic stroke patients (p<0.001) with a modest drop in 2013 to 1.9%. In multivariable analyses, patient outcomes after endovascular therapy improved over time, with reductions in in-hospital mortality (29.6% in 2004 to 16.2% in 2013; p=0.002); and from late 2010, reduction in symptomatic intracranial hemorrhage (ICH) (11% in 2010 to 5% in 2013; p<0.0001) and increased independent ambulation at discharge (24.5% in 2010 to 33% in 2013; p<0.0001) and discharge home (17.7% in 2010 to 26.1% in 2013; p<0.0001) (Attached figure). Hospital characteristics associated with endovascular therapy use included large size, teaching status and urban location while patient characteristics included younger age, EMS transport, absence of prior stroke and white race. Conclusion: Use of endovascular therapy increased modestly in this national registry from 2003 to 2012 and decreased in 2013. Clinical outcomes improved notably from 2010 to 2013, coincident with the introduction of newer thrombectomy devices.


Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Peter Vanacker ◽  
Dimitris Lambrou ◽  
Ashraf Eskandari ◽  
Patrik Michel

Aims: Endovascular treatment (EVT) for acute ischemic stroke (AIS) is the new standard of care for well selected, large vessel occlusive strokes. Hypothesis: We aimed to determine the frequency of patients potentially eligible for IV thrombolysis (IVT) and EVT based on the latest AHA/ASA guidelines. Methods: Data from a prespecified consecutive AIS registry (ASTRAL, 2003-2014) of a single comprehensive stroke center were examined. All AIS admitted <24hours and sufficient data to determine EVT-eligibility according to AHA/ASA guidelines (class I and IIa recommendations) on IVT and EVT were selected. Another set of more liberal criteria from different EVT trials and clinical practice was also tested. Time windows for EVT-eligibility was 4.5h (allowing for a door-to-groin delay ≤90min) and for IVT 3.5h (door-to-needle delay ≤60min). Results: A total of 2’704 AIS were included, of whom 26.8% were secondary transferrals. Proportion of IVT-eligible patients was 12.4% for all AIS, and 24.6% and 36.2% for patient arriving <24h and 6h respectively. Frequency of EVT-eligibility differed between the AHA/ASA guideline and the more liberal approach: 2.9% vs. 4.9% of all AIS and 10.5% vs. 17.7% of all patients arriving <6hours. These numbers are in line with the effective number of EVT applied in 2013 (15%) and 2014 (12%). Conclusions: Of patients arriving within 6h at a comprehensive stroke center, 10.5% are EVT eligible according to AHA/ASA criteria, nearly double (17.7%) with more liberal criteria, and again double for IV thrombolysis (36.2%). These figures may be useful for planning resource needs of stroke care on a regional level.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6061-6061
Author(s):  
Pau Guillen Sentis ◽  
Carmen Castillo Manzano ◽  
Beatriz Quirós ◽  
Francisca Morey Cortes ◽  
Sara Tous ◽  
...  

6061 Background: Treatment (ttm) of cancer patients (pts) was compromised during the first wave of COVID19 pandemic due to collapse of healthcare systems. Standard of care (SOC) for LA-HNSCC pts had to be adapted as operating rooms were temporarily unavailable, and to reduce risk of COVID19 exposure. The IMPACCT study evaluated the outcome of LA-HNSCC pts treated at the Catalan Institute of Oncology during the first semester of 2020 and compared it to a control cohort previously treated in the same institution. Methods: Retrospective single institution analysis of two consecutively-treated cohorts of newly-diagnosed HNSCC pts: from January to June of 2020 (CT20) and same period of 2018 and 2019 (CT18-19). Pt demographics and disease characteristics were obtained from our in-site prospective database. Ttm modifications from SOC as per COVID19-contingency protocol in CT20 for LA-HNSCC were collected. Chi-squared was used to compare variables and ttm response between cohorts. One-year recurrence-free survival (1yRFS) and overall survival (1yOS) of LA-HNSCC pts were estimated by Kaplan-Meier method and compared by Log-rank test. Results: A total of 306 pts were included: CT20=99; CT18-19=207. Baseline characteristics were balanced between cohorts (Table1). In pts treated with conservative ttm (non-surgical approach), persistence disease was higher in CT20 vs CT18-19 (26 vs. 10% p=0.02). Median follow-up of CT20 and CT18-19 was 6.8 months (IQR 5.1-7.9) and 12.3 (6.7-18.4), respectively. A trend towards lower 1yRFS and 1yOS was observed in CT20 vs CT18-19 (72 vs 83% p=0.06; 80 vs 84% p=0.07), respectively. Within CT20, 37 pts (37%) had one or more ttm modifications: switch from surgery to conservative ttm (n=13); altered radiotherapy fractionation (n=14); reduced cisplatin cumulative dose to 200mg/m2 (n=19); no adjuvant ttm (n=1). Pts who received modified ttm had no differences in 1yRFS vs those who did not (80 vs 66% p=0.31), but higher 1yOS was observed (97 vs 67% p<0.01). When stratified by stage, 1yOS difference remained significant in stage III/IVA (100 vs 61% p<0.01) but not in I/II (100 vs 77% p=0.28) or IVB (67 vs 50% p=0.54). Conclusions: COVID19 pandemic had a negative impact on ttm outcomes and survival in LA-HNSCC pts when compared to our historical cohort. Ttm modifications based on COVID19-contingency protocol did not compromise ttm efficacy in terms of RFS and was associated with better OS in Stage III/IVA.[Table: see text]


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