An observational study in Intracerebral Haemorrhage, Paediatric Stroke and Stroke Acute, sponsored by Charite University, Berlin, Germany. Not yet recruiting at 12 sites in Germany. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Charite University, Berlin, Germany · Observational
The Stroke-CORE cohort aims to provide a comprehensive and up-to-date understanding of stroke care in Germany. To achieve this, patients are followed along the entire continuum of care-from initial management before hospital admission, through acute treatment, rehabilitation, and follow-up care, to the prevention of recurrent strokes. Strokes occurring in childhood are also included in this cohort study.
In addition, the study seeks to establish effective structures for the early identification and inclusion of patients in clinical research (screening). In this context, structured screening processes are being implemented across all levels of care at participating sites within the Network University Medicine (NUM), a collaboration of German university hospitals. At the same time, the cohort serves as a platform within this network to systematically address open research questions in various areas of stroke care and to support the targeted planning and conduct of future clinical studies.
The study includes patients with ischemic stroke (caused by a blocked blood vessel) or intracerebral hemorrhage (bleeding within the brain). Participation takes place in different thematic modules, each focusing on specific aspects of the disease course and its management. These modules address, among other topics, acute hospital treatment, measures to prevent recurrent strokes (secondary prevention), possible complications, pre-hospital care, rehabilitation, follow-up care, and long-term outcomes such as physical recovery, independence in daily life, and cognitive functions including memory and concentration.
As part of the study, a range of data is collected. This includes sociodemographic information (such as age and living situation) as well as medical data, for example on prior conditions, diagnoses, treatments, and comorbidities. In addition, patients' health status is assessed at multiple time points in order to better understand the course of the disease. Depending on the level of participation, data collection may be complemented by the collection of biological samples, such as blood. These are obtained either during routine clinical procedures or through simple, minimally burdensome (non-invasive) methods.
The study is structured into several levels that differ in the scope and depth of data collection. The basic level includes essential information, while higher levels involve more detailed assessments. In addition, some levels include the collection of biological samples, and there are optional supplementary modules in which patients may participate voluntarily. This tiered approach allows participation to be flexibly adapted to the individual situation while contributing to a nuanced and comprehensive understanding of stroke care.
457 studies on the registry are indexed under Cerebral Hemorrhage; 172 are open to participants now.
This study's planned enrollment of 12,750 is above the median of 300 across 180 observational studies indexed under Cerebral Hemorrhage.
Browse Cerebral Hemorrhage studies →Charite University, Berlin, Germany is the lead sponsor of 857 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Stroke patients with criteria defined in each individual Module (IS, ICH, peadiatric stroke) who are admitted to one of the participating university hospitals in Germany within 24 hours of symptom onset.
General inclusion and exclusion criteria:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This module aims to collect comprehensive, longitudinal data on patients with acute IS to characterise clinical and imaging-derived predictors of outcome. The module is embedded within the broader cohort framework (Level 1) and focuses specifically on causes of IS, treatment during the acute phase, as well as complications, and secondary prevention. Data collection and follow up measures is aligned with the routine collection of quality-assurance data from the German Stroke Registers Study Group ('Arbeitsgemeinschaft Deutschsprachiger Schlaganfall Register' \[ADSR\], https://www.schlaganfallregister.org) and the ICHOM Standard Set for Stroke (https://www.ichom.org/patient-centered-outcome-measure/stroke/).
This module aims to collect data on adult patients presenting with spontaneous intracerebral haemorrhage (ICH). Participants will be characterised regarding demographics, clinical factors, treatment, and imaging features, including haematoma size, location, expansion dynamics, and the presence of spot sign. The study will aim to identify baseline clinical and imaging predictors of in-hospital and 3-month mortality and functional independence, to explore subgroups with distinct prognostic trajectories, and to investigate associations between clinical presentation, imaging parameters, and post-stroke complications. These analyses will inform risk stratification, guide neuroprotective and acute management strategies, and support the development of tailored interventional approaches in ICH.
adaptive research platform addressing various and for the 3 groups different research questions
Outcomes include disease severity, standard of care, complications, recurrent ischaemic or haemorrhagic stroke, burden and impact of disease and treatment on quality of life, functional outcome and survival at different time points. Since SN Stroke is an adaptive research platform addressing various research questions, additional outcomes and different determinants influencing these outcomes may be added in each module.
Time frame: Depending on the group, outcome measures will be collected through study completion, primarily at baseline, follow-up at 3 and/or 6 months, and annually, with an average follow-up period expected to be 1 year.
Plan to share: Yes — All collected IPD-including medical, biosamples, and imaging data as well as their analysis results-will be shared under strict governance. Secondary use is managed through defined Dynamic Use \& Access (DUA) procedures, aligned with the NUM Publication Policy and Terms of Use, ensuring recognition of contributing sites and researchers while maintaining high data protection standards. Applications must be submitted via a central application platform offering all required information and application documents. The DUA procedure includes: Application submission Formal review Technical, scientific, and methodological evaluation Decision by the relevant UA Committees Data provision via a data transfer office following approval of the application. Data and biosamples are only released following rigorous review, ensuring compliance with ethical, legal, and data protection requirements. Use is limited to the analyses specified in the application.
Time frame: At the earliest, following the first interim analysis, which is currently scheduled for mid-2027. Subject to future funding opportunities, the study itself and data sharing is planned to be conducted over the long term.
Access criteria: Data, imaging data and biosamples of stroke patients may be requested by any natural or legal person. A request must be submitted in accordance with the procedures described above, must be scientifically justified, and must fit within the framework established by this protocol and, more importantly, the scope of the ICF signed by the patients in the study. Before data and biosamples of accepted applications are transferred, the applicant or someone from the application team must provide a positive vote or a waiver from the Ethics Committee responsible for the applicant.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany →