Prognostic Value of Various Hemostasis Parameters and Neurophysiological Examinations in Spontaneous Intracerebral Hemorrhage: The IRONHEART Study Protocol
Rationale: Stroke is one of the leading causes of death in all developed countries. In Hungary, more than 10,000 patients die annually due to cerebrovascular diseases according to the WHO Mortality Database. Of these patients, 10–15 % suffer non-traumatic intracerebral hemorrhage (ICH). ICH results...
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Frontiers Media S.A.
2021-03-01
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Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2021.615177/full |
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author | Tamás Árokszállási Máté Héja Zsuzsa Bagoly Zsuzsa Bagoly Kitti Bernadett Kovács Rita Orbán-Kálmándi Ferenc Sarkady Judit Tóth Klára Fekete István Fekete László Csiba László Csiba |
author_facet | Tamás Árokszállási Máté Héja Zsuzsa Bagoly Zsuzsa Bagoly Kitti Bernadett Kovács Rita Orbán-Kálmándi Ferenc Sarkady Judit Tóth Klára Fekete István Fekete László Csiba László Csiba |
author_sort | Tamás Árokszállási |
collection | DOAJ |
description | Rationale: Stroke is one of the leading causes of death in all developed countries. In Hungary, more than 10,000 patients die annually due to cerebrovascular diseases according to the WHO Mortality Database. Of these patients, 10–15 % suffer non-traumatic intracerebral hemorrhage (ICH). ICH results in a higher rate of mortality as compared to ischemic stroke and outcomes are difficult to predict. In the IRONHEART study, we aim to test various hemostasis parameters and clinical neurophysiological examinations in evaluating outcome in ICH.Methods: In this prospective, observational study, we plan to enroll consecutive patients with non-traumatic spontaneous ICH admitted to a single Stroke Center (Department of Neurology, University of Debrecen, Hungary). The protocol of the IRONHEART study includes the investigation of detailed clinical, laboratory investigations, and various neurophysiological examinations. Stroke severity is quantified based on the National Institutes of Health Stroke Scale (NIHSS) on admission and day 7, 14, and 90 after the onset of stroke. Cranial CT is performed on admission, day 14, and 90 to estimate the ICH volume. Modified Rankin Scale (mRS) is used for evaluating the long-term outcome (90 days post-event). Blood is drawn immediately on admission for specific hemostasis tests. Digital and quantitative EEG techniques and motor evoked potential (MEP) are performed to evaluate the prognosis of cerebral hemorrhage on admission (within 24–48 h), immediately before discharge (~10–14 days later), and 3 months after the event.Outcomes: The following outcomes are investigated: primary outcomes: mortality by day 14 and day 90, secondary long-term outcome at 90 days post-event where mRS 0–2 is defined as favorable long-term outcome.Discussion: If associations between outcomes and the investigated parameters (hemostasis and neurophysiological examinations) are confirmed, results might aid prognosis assessment in this subtype of stroke with particularly high mortality. Improving clinical grading systems on ICH severity and outcomes by including the investigated parameters could help to better guide the management of these patients in the future. |
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spelling | doaj.art-13840210364a45b199c6196307cbc4732022-12-21T22:57:24ZengFrontiers Media S.A.Frontiers in Neurology1664-22952021-03-011210.3389/fneur.2021.615177615177Prognostic Value of Various Hemostasis Parameters and Neurophysiological Examinations in Spontaneous Intracerebral Hemorrhage: The IRONHEART Study ProtocolTamás Árokszállási0Máté Héja1Zsuzsa Bagoly2Zsuzsa Bagoly3Kitti Bernadett Kovács4Rita Orbán-Kálmándi5Ferenc Sarkady6Judit Tóth7Klára Fekete8István Fekete9László Csiba10László Csiba11Department of Neurology, Faculty of Medicine, University of Debrecen, Debrecen, HungaryDepartment of Neurology, Faculty of Medicine, University of Debrecen, Debrecen, HungaryMagyar Tudományos Akadémia-Debreceni Egyetem (MTA-DE) Cerebrovascular and Neurodegenerative Research Group, University of Debrecen, Debrecen, HungaryDivision of Clinical Laboratory Sciences, Department of Laboratory Medicine, Faculty of Medicine, University of Debrecen, Debrecen, HungaryDepartment of Neurology, Faculty of Medicine, University of Debrecen, Debrecen, HungaryDivision of Clinical Laboratory Sciences, Department of Laboratory Medicine, Faculty of Medicine, University of Debrecen, Debrecen, HungaryDivision of Clinical Laboratory Sciences, Department of Laboratory Medicine, Faculty of Medicine, University of Debrecen, Debrecen, HungaryDepartment of Radiology, Faculty of Medicine, University of Debrecen, Debrecen, HungaryDepartment of Neurology, Faculty of Medicine, University of Debrecen, Debrecen, HungaryDepartment of Neurology, Faculty of Medicine, University of Debrecen, Debrecen, HungaryDepartment of Neurology, Faculty of Medicine, University of Debrecen, Debrecen, HungaryMagyar Tudományos Akadémia-Debreceni Egyetem (MTA-DE) Cerebrovascular and Neurodegenerative Research Group, University of Debrecen, Debrecen, HungaryRationale: Stroke is one of the leading causes of death in all developed countries. In Hungary, more than 10,000 patients die annually due to cerebrovascular diseases according to the WHO Mortality Database. Of these patients, 10–15 % suffer non-traumatic intracerebral hemorrhage (ICH). ICH results in a higher rate of mortality as compared to ischemic stroke and outcomes are difficult to predict. In the IRONHEART study, we aim to test various hemostasis parameters and clinical neurophysiological examinations in evaluating outcome in ICH.Methods: In this prospective, observational study, we plan to enroll consecutive patients with non-traumatic spontaneous ICH admitted to a single Stroke Center (Department of Neurology, University of Debrecen, Hungary). The protocol of the IRONHEART study includes the investigation of detailed clinical, laboratory investigations, and various neurophysiological examinations. Stroke severity is quantified based on the National Institutes of Health Stroke Scale (NIHSS) on admission and day 7, 14, and 90 after the onset of stroke. Cranial CT is performed on admission, day 14, and 90 to estimate the ICH volume. Modified Rankin Scale (mRS) is used for evaluating the long-term outcome (90 days post-event). Blood is drawn immediately on admission for specific hemostasis tests. Digital and quantitative EEG techniques and motor evoked potential (MEP) are performed to evaluate the prognosis of cerebral hemorrhage on admission (within 24–48 h), immediately before discharge (~10–14 days later), and 3 months after the event.Outcomes: The following outcomes are investigated: primary outcomes: mortality by day 14 and day 90, secondary long-term outcome at 90 days post-event where mRS 0–2 is defined as favorable long-term outcome.Discussion: If associations between outcomes and the investigated parameters (hemostasis and neurophysiological examinations) are confirmed, results might aid prognosis assessment in this subtype of stroke with particularly high mortality. Improving clinical grading systems on ICH severity and outcomes by including the investigated parameters could help to better guide the management of these patients in the future.https://www.frontiersin.org/articles/10.3389/fneur.2021.615177/fullintracerebral hemorrhageoutcomeclot lysismotor evoked potentialquantitative electroencephalography |
spellingShingle | Tamás Árokszállási Máté Héja Zsuzsa Bagoly Zsuzsa Bagoly Kitti Bernadett Kovács Rita Orbán-Kálmándi Ferenc Sarkady Judit Tóth Klára Fekete István Fekete László Csiba László Csiba Prognostic Value of Various Hemostasis Parameters and Neurophysiological Examinations in Spontaneous Intracerebral Hemorrhage: The IRONHEART Study Protocol Frontiers in Neurology intracerebral hemorrhage outcome clot lysis motor evoked potential quantitative electroencephalography |
title | Prognostic Value of Various Hemostasis Parameters and Neurophysiological Examinations in Spontaneous Intracerebral Hemorrhage: The IRONHEART Study Protocol |
title_full | Prognostic Value of Various Hemostasis Parameters and Neurophysiological Examinations in Spontaneous Intracerebral Hemorrhage: The IRONHEART Study Protocol |
title_fullStr | Prognostic Value of Various Hemostasis Parameters and Neurophysiological Examinations in Spontaneous Intracerebral Hemorrhage: The IRONHEART Study Protocol |
title_full_unstemmed | Prognostic Value of Various Hemostasis Parameters and Neurophysiological Examinations in Spontaneous Intracerebral Hemorrhage: The IRONHEART Study Protocol |
title_short | Prognostic Value of Various Hemostasis Parameters and Neurophysiological Examinations in Spontaneous Intracerebral Hemorrhage: The IRONHEART Study Protocol |
title_sort | prognostic value of various hemostasis parameters and neurophysiological examinations in spontaneous intracerebral hemorrhage the ironheart study protocol |
topic | intracerebral hemorrhage outcome clot lysis motor evoked potential quantitative electroencephalography |
url | https://www.frontiersin.org/articles/10.3389/fneur.2021.615177/full |
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