Comparing extended versus standard time window for thrombectomy: caseload, patient characteristics, treatment rates and outcomes-a prospective single-centre study.
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ABSTRACT: Purpose
New guidelines recommend thrombectomy up to 24 h in selected patients; however, the workload and benefit of extending time window are not known. We conducted a prospective single-centre study to determine the caseload, imaging and interventional need of extended time window.Methods
All consecutive ischemic stroke patients within 24 h from onset in an 11-month period were included. Thrombectomy eligibility in the 0-6 h time window was based on current guidelines; in the 6-24 h time window, it was based on a combination of DEFUSE 3 and DAWN study criteria using MRI to identify target mismatch. Clinical outcome in treated patients was assessed at 3 months.Results
Within 24 h of onset, 437 patients were admitted. In the 0-6 h time window, 238 patients (54.5%) arrived of whom 221 (92.9%) underwent CTA or MRA, 82 (34.5%) had large vessel occlusion (LVO), 30 (12.6%) had thrombectomy and 11 (36.6%) became independent (mRS ≤ 2). In the extended 6-24 h time window, 199 patients (45.5%) arrived of whom 127 (63.8%) underwent CTA or MRA, 44 (22.1%) had LVO, 8 (4%) had thrombectomy and 4 (50%) became independent.Conclusion
Extending the time window from 6 to 24 h results in a 26.7% increase in patients receiving thrombectomy and a 36.4% increase of independent clinical outcome in treated patients at the price of a significantly increased burden of clinical and imaging screening due to the similar caseload but a smaller proportion of treatment eligible patients in the extended as compared with the standard time window.
SUBMITTER: Gunda B
PROVIDER: S-EPMC7966226 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:RationaleThe benefit of thrombectomy in patients with intracranial large vessel occlusion of the anterior circulation has been shown in selected patients in previous randomized controlled trials, but patients with extended ischemic lesions were excluded in the majority of these trials. TENSION aims to demonstrate efficacy and safety of thrombectomy in patients with extended lesions in an extended time window (up to 12 h from onset or from last seen well).DesignTENSION is an investigator-initiated, randomized controlled, open label, blinded endpoint, European, two-arm, postmarket study to compare the safety and effectiveness of thrombectomy as compared to best medical care alone in stroke patients with extended stroke lesions defined by an Alberta Stroke Program Early Computed Tomography Scan score of 3-5 and in an extended time window. In an adaptive design study, up to 665 patients will be randomized.OutcomesPrimary efficacy endpoint will be clinical outcome defined by the modified Rankin Scale at 90-day poststroke. The main safety endpoint will be death and dependency (modified Rankin Scale 4-6) at 90 days. Additional effect measures include adverse events, health-related quality of life, poststroke depression, and costs utility assessment.DiscussionTENSION may make effective treatment available for patients with severe stroke in an extended time window, thereby improving functional outcome and quality of life of thousands of stroke patients and reducing the individual, societal, and economic burden of death and disability resulting from severe stroke. TENSION is registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT03094715).
| S-EPMC6604397 | biostudies-literature
Project description:Multipass hemodialysis (MPHD) is a recently described dialysis modality, involving the use of small volumes of dialysate which are repetitively recycled. Dialysis regimes of 8 hours for six days a week using this device result in an increased removal of small water soluble solutes and middle molecules compared to standard hemodialysis (SHD). Since protein-bound solutes (PBS) exert important pathophysiological effects, we investigated whether MPHD results in improved removal of PBS as well.A cross-over study (Clinical Trial NCT01267760) was performed in nine stable HD patients. At midweek a single dialysis session was performed with either 4 hours SHD using a dialysate flow of 500 mL/min or 8 hours MPHD with a dialysate volume of 50% of estimated body water volume. Blood and dialysate samples were taken every hour to determine concentrations of p-cresylglucuronide (PCG), hippuric acid (HA), indole acetic acid (IAA), indoxyl sulfate (IS), and p-cresylsulfate (PCS). Dialyser extraction ratio, reduction ratio, and solute removal were calculated for these solutes.Already at 60 min after dialysis start, the extraction ratio in the hemodialyser was a factor 1.4-4 lower with MPHD versus SHD, resulting in significantly smaller reduction ratios and lower solute removal within a single session. Even when extrapolating our findings to 3 times 4 h SHD and 6 times 8 h MPHD per week, the latter modality was at best similar in terms of total solute removal for most protein-bound solutes, and worse for the highly protein-bound solutes IS and PCS. When efficiency was calculated as solute removal/litre of dialysate used, MPHD was found superior to SHD.When high water consumption is a concern, a treatment regimen of 6 times/week 8 h MPHD might be an alternative for 3 times/week 4 h SHD, but at the expense of a lower total solute removal of highly protein-bound solutes.
| S-EPMC4404563 | biostudies-literature
Project description:BackgroundLittle research has examined how media outreach strategies affect the outcomes of contraceptive initiatives. Thus, this paper assesses the potential impact of an online media campaign introduced during the last six months of a contraceptive initiative study based in Salt Lake City, UT (USA).MethodsDuring the last six months of the HER Salt Lake Contraceptive Initiative (September 2016-March 2017), we introduced an online media campaign designed to connect potential clients to information about the initiative and a brief (9-item) appointment request form (via HERsaltlake.org). Using linked data from the online form and electronic medical records, we examine differences in demographics, appointment show rates, and contraceptive choices between "online requester" clients who made clinical appointments through the online form (n = 356) and "standard requester" clients who made appointments using standard scheduling (n = 3,051). We used summary statistics and multivariable regression to compare groups.ResultsThe campaign logged 1.7 million impressions and 15,765 clicks on advertisements leading to the campaign website (HERSaltLake.org). Compared to standard requesters, online requesters less frequently reported a past pregnancy and were more likely to be younger, white, and to enroll in the survey arm of the study. Relative to standard requesters and holding covariates constant, online requesters were more likely to select copper IUDs (RRR: 8.14), hormonal IUDs (RRR: 12.36), and implants (RRR: 10.75) over combined hormonal contraceptives (the contraceptive pill, patch, and ring). Uptake of the contraceptive injectable, condoms, and emergency contraception did not differ between groups.ConclusionClients demonstrating engagement with the media campaign had different demographic characteristics and outcomes than those using standard scheduling to arrange care. Online media campaigns can be useful for connecting clients with advertised contraceptive methods and initiatives. However, depending on design strategy, the use of media campaigns might shift the demographics and characteristics of clients who participate in contraceptive initiatives.Trial registrationClinicaltrials.gov identifier NCT02734199, Registered 12 April 2016-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02734199 .
| S-EPMC7986020 | biostudies-literature
Project description:BackgroundPrevious incomplete studies investigating the potential of chewing gum (CG) in patients undergoing colorectal resection did not obtain definitive conclusions. This updated meta-analysis was therefore conducted to evaluate the effect and safety of CG versus standard postoperative care protocols (SPCPs) after colorectal surgery.ResultsTotal 26 RCTs enrolling 2214 patients were included in this study. The CG can be well-tolerated by all patients. Compared with SPCPs, CG was associated with shorter time to first flatus (weighted mean difference (WMD) -12.14 (95 per cent c.i. -15.71 to -8.56) hours; P < 0.001), bowl movement (WMD -17.32 (-23.41 to -11.22) hours; P < 0.001), bowel sounds (WMD -6.02 (-7.42 to -4.63) hours; P < 0.001), and length of hospital stay (WMD -0.95 (-1.55 to -0.35) days; P < 0.001), a lower risk of postoperative ileus (risk ratio (RR) 0.61 (0.44 to 0.83); P = 0.002), net beneficial and quality of life. There were no significant differences between the two groups in overall complications, nausea, vomiting, bloating, wound infection, bleeding, dehiscence, readmission, reoperation, mortality.Materials and methodsThe potentially eligible randomized controlled trials (RCTs) that compared CG with SPCPs for colorectal resection were searched in PubMed, Embase, Cochrane library, China National Knowledge Infrastructure (CNKI), and Chinese Wanfang databases through May 2016. The trial sequential analysis was adopted to examine whether a firm conclusion for specific outcome can be drawn.ConclusionsCG is benefit for enhancing return of gastrointestinal function after colorectal resection, and may be associated with lower risk of postoperative ileus.
| S-EPMC5342535 | biostudies-literature
Project description:BackgroundResearch on caseload midwifery in a Danish setting is missing. This cohort study aimed to compare labour outcomes in caseload midwifery and standard midwifery care.MethodsA historical register-based cohort study was carried out using routinely collected data about all singleton births 2013-2016 in two maternity units in the North Denmark Region. In this region, women are geographically allocated to caseload midwifery or standard care, as caseload midwifery is only available in some towns in the peripheral part of the uptake areas of the maternity units, and it is the only model of care offered here. Labour outcomes of 2679 all-risk women in caseload midwifery were compared with those of 10,436 all-risk women in standard midwifery care using multivariate linear and logistic regression analyses.ResultsCompared to women in standard care, augmentation was more frequent in caseload women (adjusted odds ratio (aOR) 1.20; 95% CI 1.06-1.35) as was labour duration of less than 10?h (aOR 1.26; 95% CI 1.13-1.42). More emergency caesarean sections were observed in caseload women (aOR 1.17; 95% CI 1.03-1.34), but this might partly be explained by longer distance to the maternity unit in caseload women. When caseload women were compared to women in standard care with a similar long distance to the hospital, no difference in emergency caesarean sections was observed (aOR 1.04; 95% CI 0.84-1.28). Compared to standard care, infants of caseload women more often had Apgar ?7 after 5?min. (aOR 1.57; 95% CI 1.11-2.23) and this difference remained when caseload women were compared to women with similar distance to the hospital. For elective caesarean sections, preterm birth, induction of labour, dilatation of cervix on admission, amniotomy, epidural analgesia, and instrumental deliveries, we did not obseve any differences between the two groups. After birth, caseload women more often experienced no laceration (aOR 1.17; 95% CI 1.06-1.29).ConclusionsFor most labour outcomes, there were no differences across the two models of midwifery-led care but unexpectedly, we observed slightly more augmentation and adverse neonatal outcomes in caseload midwifery. These findings should be interpreted in the context of the overall low intervention and complication rates in this Danish setting and in the context of research that supports the benefits of caseload midwifery. Although the observational design of the study allows only cautious conclusions, this study highlights the importance of monitoring and evaluating new practices contextually.
| S-EPMC6282374 | biostudies-literature
Project description:IntroductionCaregivers are essential for the health, safety, and independence of many patients and incur financial and personal cost in this role, including increased burden and lower quality of life (QOL) compared to the general population. Extended-hours hemodialysis may be the preference of some patients, but little is known about its effects on caregivers.MethodsForty caregivers of participants of the ACTIVE Dialysis trial, who were randomized to 12 months extended (median 24 hours/wk) or standard (12 hours/wk) hemodialysis, were included. Utility-based QOL was measured by EuroQOL-5 Dimension-3 Level (EQ-5D-3L) and Short Form-6 Dimensions (SF-6D) and health-related QOL (HRQOL) was measured by the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary (MCS) and the Personal Wellbeing Index (PWI) at enrolment and then every 3 months until the end of the study.ResultsAt baseline, utility-based QOL and HRQOL were similar in both groups. At follow-up, caregivers of people randomized to extended-hours dialysis experienced a greater decrease in utility-based QOL measured by EQ-5D-3L compared with caregivers of people randomized to standard hours (-0.18±0.30 vs. -0.02±0.16, P = 0.04). There were no differences between extended- and standard-hours groups in mean change in SF-6D (0.03±0.12 vs. -0.04±0.1, P = 0.8), PCS (-1.2±9.8 vs. -5.6±9.8, P = 0.2), MCS (-4.1±11.2 vs. -0.5±7.1, P = 0.4), and PWI (2.3±17.6 vs. 0.00±20.4, P = 0.9).ConclusionPoorer utility-based QOL, as measured by the EQ-5D-3L, was observed in caregivers of patients receiving extended-hours hemodialysis in this small study. Though the findings are exploratory, the possibility that mode of dialysis delivery negatively impacts on caregivers supports the prioritization of research on burden and impact of service delivery in this population.
| S-EPMC8071646 | biostudies-literature
Project description:BackgroundLymph node involvement in pancreatic adenocarcinoma is a key prognostic factor. Therefore, extending the number of lymph node stations excised in pancreatoduodenectomy may be beneficial to patients with pancreatic adenocarcinoma. This systematic review and meta-analysis examines the outcomes of extended versus standard lymphadenectomy in the published literature.MethodsA meta-analysis of randomized controlled trials (RCTs) comparing extended with standard lymphadenectomy in patients undergoing pancreatoduodenectomy for pancreatic adenocarcinoma was performed. Perioperative outcomes were assessed as pooled odds ratios (ORs) and weighted mean differences. Overall survival was analysed for patients with positive and negative lymph nodes. Results were reported according to the PRISMA statement.ResultsFive RCTs were included, accounting for 724 patients. Extended lymphadenectomy was associated with greater operative time [mean difference: 63 min, 95% confidence interval (CI) 29-96; P < 0.001], increased need for blood transfusions (mean difference: 0.20, 95% CI 0.01-0.30; P = 0.030) and greater postoperative morbidity (OR 1.5, 95% CI 1.25-2.00; P = 0.030), as well as with prolonged diarrhoea after circumferential autonomic nerve dissection around major vessels (OR 12.2, 95% CI 5.3-28.5; P < 0.001). Median survival was similar across the groups in the whole cohort, as well as in subgroups of patients with, respectively, positive and negative lymph nodes.ConclusionsExtended lymphadenectomy has a harmful impact on patients undergoing oncological pancreatoduodenectomy compared with standard lymphadenectomy.
| S-EPMC4474502 | biostudies-literature
Project description:A standardised procedure for making fair and comparable assessments of the ultraviolet protection of an established tree canopy that takes into account canopy movement and the changing position of the sun is presented for use by government, planning, and environmental health authorities. The technique utilises video image capture and replaces the need for measurement by ultraviolet radiometers for surveying shade quality characteristics of trees growing in public parks, playgrounds and urban settings. The technique improves upon tree shade assessments that may be based upon single measurements of the ultraviolet irradiance observed from a fixed point of view. The presented technique demonstrates how intelligent shade audits can be conducted without the need for specialist equipment, enabling the calculation of the Shade Protection Index (SPI) and Ultraviolet Protection Factor (UPF) for any discreet time interval and over a full calendar year. •Tree shade UPF measurements are presented using video capture analysis of moving canopies•A standard method for making accurate assessments of tree shade has been developed•Tree shade comparisons are made without the need for specialist equipment.
| S-EPMC6682329 | biostudies-literature
Project description:BackgroundAdults with cystic fibrosis (CF) have been reported to be at five to ten-fold risk (25 to 30 fold risk after solid organ transplant) of colorectal cancer (CRC) than the general population. Limited publications to date have reported on practical aspects of achieving adequate colonic cleanse producing good visualisation. In this study, we compared two bowel preparation regimens, standard bowel preparation and a modified CF bowel preparation.MethodsA non-randomised study of adults with CF attending a single centre, requiring colonoscopy investigation were selected. Between 2001 and 2015, 485 adults with CF attended the clinic; 70 adults with CF had an initial colonoscopy procedure. After five exclusions, standard bowel preparation was prescribed for 27 patients, and modified CF bowel preparation for 38 patients. Demographic and clinical data were collected for all consenting patients.ResultsThere was a significant difference between modified CF bowel preparation group and standard bowel preparation group in bowel visualisation outcomes, with the modified CF bowel preparation group having a higher proportion of "excellent/good" GI visualisation cleanse (50.0% versus 25.9%) and lower rates of "poor" visualisation cleanse (10.5% versus 44.5%) than standard bowel preparation (p?=?0.006). Rates of "fair" GI cleanse visualisation were similar between the two groups (39.4% versus 29.6%) (Additional file 1: Table S1). Detection rates of adenomatous polyps at initial colonoscopy was higher in modified CF bowel preparation cohort than with standard preparation group (50.0% versus 18.5%, p <?0.01). Positive adenomatous polyp detection rate in patient's age?>?40?years of age was higher (62.5%) than those <?40?years of age (24.3%) (p?=?0.003). Colonic adenocarcinoma diagnosis was similar in both groups.ConclusionThis study primarily highlights that standard colonoscopy bowel preparation is often inadequate in patients with CF, and that colonic lavage using modified CF bowel preparation is required to obtain good colonic visualisation. A higher rate of polyps in patients over 40?years of age (versus less than 40?years) was evident. These results support adults with CF considered for colonoscopy screening at 40?years of age, or prior to this if symptomatic; which is earlier than CRC screening in the non-CF Australian population.
| S-EPMC6567575 | biostudies-literature
Project description:BackgroundHypotension and blood pressure (BP) variability during endovascular therapy (EVT) for acute ischemic stroke (AIS) due to an anterior large vessel occlusion (LVO) is associated with worse outcomes. However, the optimal BP threshold during EVT is still unknown given the lack of randomized controlled evidence. We designed the DETERMINE trial to assess whether an individualized BP management during EVT could achieve better functional outcomes compared to a standard BP management.MethodsThe DETERMINE trial is a multicenter, prospective, randomized, controlled, open-label, blinded endpoint clinical trial (PROBE design). AIS patients with a proximal anterior LVO are randomly assigned, in a 1:1 ratio, to an experimental arm in which mean arterial pressure (MAP) is maintained within 10% of the first MAP measured before EVT, or a control arm in which systolic BP (SBP) is maintained within 140-180 mm Hg until reperfusion is achieved or artery closure in case of EVT failure. The primary outcome is the rate of favorable functional outcomes, defined by a modified Rankin Scale (mRS) between 0 and 2 at 90 days. Secondary outcomes include excellent outcome and ordinal analysis of the mRS at 90 days, early neurological improvement at 24 h (National Institutes of Health Stroke Scale), final infarct volume, symptomatic intracranial hemorrhage rates, and all-cause mortality at 90 days. Overall, 432 patients will be included.DiscussionDETERMINE will assess the clinical relevance of an individualized BP management before reperfusion compared to the one size fits all approach currently recommended by international guidelines.Trial registrationClinicalTrials.gov , NCT04352296. Registered on 20th April 2020.
| S-EPMC9317065 | biostudies-literature