Prognostic Value of Various Hemostasis Parameters and Neurophysiological Examinations in Spontaneous Intracerebral Hemorrhage: The IRONHEART Study Protocol

Abstract

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.

Thrombin generation as a predictor of outcomes in patients with non-traumatic intracerebral hemorrhage

“…In this prospective observational study, consecutive patients with non-traumatic intracerebral hemorrhagic stroke (ICH) were enrolled in a single stroke center (Department of Neurology, University of Debrecen, Hungary). The study protocol was published earlier ( 13 ). Patient enrollment was initiated in June 2017 and was completed in September 2020.…”

Neurophysiological Examinations as Adjunctive Tool to Imaging Techniques in Spontaneous Intracerebral Hemorrhage: IRONHEART Study

“…Between June 1 2017 and June 15 2021, 116 consecutive patients with ICH were enrolled prospectively in our observational study, conducted at the Stroke Centre (Stroke Unit, Department of Neurology, University of Debrecen, Hungary) in the GINOP “IRONHEART Study.” Hereby we focus on special issues only, in association with another study, since the detailed protocol was published in it quite recently ( 17 ).…”

“…Total lesion volume was calculated by multiplying the traced area (ROI, cm 2 ) with slice thickness and adding up the results ( 19 – 21 ). All tracings were performed by one radiologist ( 17 ).…”

“…Total lesion volume was calculated by multiplying the traced area (ROI, cm 2 ) with slice thickness and adding up the results (19)(20)(21). All tracings were performed by one radiologist (17). The time at symptom onset, baseline characteristics (age, sex, cerebrovascular risk factors, history of cerebrovascular and cardiovascular diseases, previous medications) were recorded on admission.…”

“…The main goals of the follow-up neurophysiological study were to investigate (1) whether the EEG correlated with the improvement or deterioration of cerebral functions, comparing data with clinical parameters [National Institutes of Health Stroke Scale (NIHSS) score, modified Rankin Scale score] and cranial computed tomography (CT) findings (measured blood volume along with edema volume; (2) early detection of epileptiform discharges or non-Convulsive seizures to select patients who may benefit from early-initiated antiseizure drug treatment. In parallel with the EEGs, we performed TMS examinations to evaluate the prognosis and the probable effectiveness of further rehabilitation (17).…”