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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Main Authors: Tamás Árokszállási, Máté Héja, Zsuzsa Bagoly, Kitti Bernadett Kovács, Rita Orbán-Kálmándi, Ferenc Sarkady, Judit Tóth, Klára Fekete, István Fekete, László Csiba
Format: Article
Language:English
Published: Frontiers Media S.A. 2021-03-01
Series:Frontiers in Neurology
Subjects:
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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