Delay to Tissue Plasminogen Activator in Hypertensive Stroke Patients: An Analysis of Delay Duration Across Agents

Carrera, Joseph F; Sorace, Brian; Worrall, Bradford B.; Southerland, Andrew M; Chiota‐McCollum, Nicole

doi:10.1016/j.jstrokecerebrovasdis.2019.104525

Cited by 3 publications

(4 citation statements)

References 11 publications

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“…Carrera (2019) also showed that people who had high blood pressure before taking Alteplase and used antihypertensive drugs had more inhospital delays than other patients; however, this difference was not statistically significant. [ 41 ] Mowla et al . (2017) also found that high blood pressure is a major factor contributing to inhospital delays.…”

Section: Discussionmentioning

confidence: 99%

Delays in receiving Alteplase and related factors in patients with stroke referred to Shahid Beheshti Hospital in Kashan-Iran in 2020-2021

Sirousinejad,

Dianati,

Kheiran

et al. 2024

Journal of Education and Health Promotion

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BACKGROUND: The benefits of using Alteplase are time-dependent. This study aimed to evaluate delays between the onset of symptoms and the administration of Alteplase and related factors in patients with acute ischemic stroke (AIS). MATERIALS AND METHODS: In this cross-sectional study, 60 AIS patients receiving Alteplase were selected by census sampling from July 2020 to July 2021 from the eligible patients referred to Shahid Beheshti Hospital in Kashan, Iran. The data collection tool was a researcher-made questionnaire containing demographic information, time periods from the onset of symptoms to the injection of Alteplase, and associated factors. The required information was collected from the patients, their relatives, their health records, and Kashan Emergency Medical Service (EMS) information system. Data were analyzed in SPSS-16. RESULTS: Eighty-five percent of the 60 patients participating in the study were transferred to the hospital by EMS ambulances. The mean time intervals between different phases were as follows: Onset-To-Door (OTD) time 81.35 ± 33.76 minutes; Door-To-CT (DTC) scan time 16.12 ± 17.46 minutes; Door-To-Needle (DNT) time 51.30 ± 26.14 minutes; and the overall Onset-To-Needle (ONT) time 133.75 ± 39.17 minutes. Also, the mean ONT in people transferred by EMS was about 129 minutes, and the longest prehospital delay in these patients was related to the time between the arrival of the EMS ambulance to the hospital. Marital status and geographical location where the stroke had occurred showed a significant relationship with prehospital delay and pre-hospital notification (PHN) by EMS But there was no relationship between underlying diseases or economic status and prehospital delays; also, the patient’s diastolic blood pressure at the time of receiving Alteplase showed a significant relationship with in-hospital delay. CONCLUSION: The findings of the study showed that the majority of people trust and use EMS ambulances to transfer to the hospital and the time spent in different stages, from the onset of symptoms to the injection of the thrombolytic drug, was in an acceptable range in the patients.

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Section: Discussionmentioning

confidence: 99%

Delays in receiving Alteplase and related factors in patients with stroke referred to Shahid Beheshti Hospital in Kashan-Iran in 2020-2021

Sirousinejad,

Dianati,

Kheiran

et al. 2024

Journal of Education and Health Promotion

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“…Besides informed consent, unreported clinical factors, such as blood pressure management, may also influence the DTT times in the included trials. (67)…”

Section: Discussionmentioning

confidence: 99%

Ethical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials

Bellomo

Fokas

Anderson

et al. 2020

Preprint

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Introduction: Obtaining informed consent from acute ischemic stroke patients poses many challenges, especially in the context of a research setting. Specifically, consenting for alternative acute ischemic stroke treatments to the standard of care, Tissue Plasminogen Activator (tPA), can cause delays leading to increased time to reperfusion and worse outcomes. Objectives: We sought to investigate the experiences of researchers in existing active-control trials in acute ischemic stroke comparing investigational therapy to tPA in order to identify the approaches and challenges in obtaining informed consent in this unique patient population. Methods: Out of 401 articles evaluated, 14 trials met inclusion criteria of patients receiving IV tPA vs alternative treatment within 4.5 hours of onset of symptoms for acute ischemic stroke. Trial representatives were emailed by the study team with a request for a copy of their patient consent form, other documents related to informed consent, and to complete a survey concerning aspects of the consent process. Results: Of the 6 trials conducted across 6 continents that completed the survey in its entirety, 2 were ongoing, 4 were published between 2009 and 2016, and the median NIHSS for each published trial was at least an 8. All published trials in the sample stated that informed consent was obtained, but only half reported involvement of a research ethics committee. Although 3 trials performed in Europe or Asia reported directly consenting 75-100% of enrolled patients, the median NIHSS for these trials represented a moderate stroke. Trials with 75-100% of patients directly consented had shorter door to treatment (DTT) times than trials that directly consented less than 50% of enrolled patients. 5 trials allowed consent by proxy, but only 2 of those trials also required patient assent. 4 trials had translators available and translated consent documents, and these trials had longer DTT times. All trials relied on experienced providers or dedicated research coordinators to obtain informed consent; however, only 2 of 6 trials mentioned specific training with regards to informed consent skills. Conclusions: The current informed consent process is not transparent and poses challenges to investigators in the USA directly comparing tPA to an alternative treatment. International differences in the standards of informed consent, such as deferred consent, may have allowed more patients with moderate strokes to provide direct consent after treatment administration without delaying DTT time. While targeted and innovative approaches for informed consent are needed to improve patient outcomes, we must balance protecting the autonomy of individuals whose willing involvement enables such pivotal discoveries. The stroke community must aim for efficiency, transparency, and inclusion of patients of diverse backgrounds in the informed consent process so that therapeutic advances are possible.

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“…Trials were additionally limited to studies listed in trial registries in English, thus excluding the pool of international studies that otherwise satisfied inclusion criteria. Besides informed consent, unreported clinical factors, such as blood pressure management, may also influence the DTT times in the included trials 51 . Finally, other countries have different regulations and consent approaches that were not captured by this study.…”

Section: Limitationsmentioning

confidence: 99%

“…Besides informed consent, unreported clinical factors, such as blood pressure management, may also influence the DTT times in the included trials. 51 Finally, other countries have different regulations and consent approaches that were not captured by this study. A new landscape for informed consent in the acute setting may be necessary to ensure medical care does not stagnate and that research can allow for the development of the next standard of care.…”

Section: Limitationsmentioning

confidence: 99%

Ethical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials

Bellomo

Fokas²,

Tsao

et al. 2022

Ethics & Human Research

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We sought to investigate the experiences of researchers in existing active-control trials in acute ischemic stroke comparing investigational therapy to tissue plasminogen activator (tPA) in order to identify the approaches and challenges in obtaining informed consent. Out of 401 articles evaluated, 14 trials met inclusion criteria. Trial representatives were contacted to complete a survey concerning the consent process. None of the 14 trials published materials related to the informed consent process. Trials with 75% to 100% of patients directly consented had shorter door-totreatment (DTT) times than trials that directly consented less than 50% of patients. Trials that had translators available (for recruiting participants who were not native speakers in the local language) and translated consent documents had longer DTT times. The study findings suggest that differences in the standards of informed consent internationally may allow more patients with moderate strokes to provide direct consent without delaying DTT time. Future trials should emphasize transparency to the public and scientific community in the informed consent process. KEYWORDS human research ethics, human subjects research, acute ischemic stroke, informed consent, randomized controlled trials, literature review

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Delay to Tissue Plasminogen Activator in Hypertensive Stroke Patients: An Analysis of Delay Duration Across Agents

Cited by 3 publications

References 11 publications

Delays in receiving Alteplase and related factors in patients with stroke referred to Shahid Beheshti Hospital in Kashan-Iran in 2020-2021

Delays in receiving Alteplase and related factors in patients with stroke referred to Shahid Beheshti Hospital in Kashan-Iran in 2020-2021

Ethical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials

Ethical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials

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