Intracerebral HaemorrhageStroke-CORENCT07553650
Master Study Protocol for the Cohort of the Specialist Network Stroke (SN Stroke)(Stroke-CORE)
An observational study of Intracerebral Haemorrhage and Paediatric Stroke, run by Charite University, Berlin, Germany at 12 sites in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intracerebral Haemorrhage, Paediatric Stroke, Stroke Acute
- How many people
- 12,750 participants
- Where
- 12 sitesGermany
- Study dates
- 27 Jul 2026to 30 Jun 2030
- How long will I take part?
- 90 Days
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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: * Fulfilment of all inclusion and no exclusion criteria for at least one Module * Signed IC from patients capable of giving consent and understanding all content of the IC or IC of an appropriate patient representative, if patients are unable to provide consent themselves.
Who may be able to join
- Diagnosis of AIS or ICH; the AIS diagnosis may be diagnosed clinically or radiologically (i.e., focal neurological impairment of sudden onset, lasting more than 24 hours and of presumed vascular origin, or with proof of cerebral ischaemia corresponding to the clinical symptoms in neuroimaging); for ICH diagnosis requires clinical symptoms and radiological diagnosis of ICH
- Hospital admission <24h after symptom onset
- Age 18+ years for the basic Modules AIS and ICH; age <18 years for the basic Module paediatric stroke patients
- Informed consent: Signed IC from patients capable of giving consent and understanding all content of the IC or IC of an appropriate patient representative or deferred consent, if patients are unable to consent themselves
- Additional inclusion criteria are defined by the individual Modules
Who cannot join
- In-hospital stroke
- TIA
- SAH
- Stroke as a complication of a medical procedure
- Enrolment in a randomised placebo-controlled interventional trial
- Already enrolled in the SN STROKE base cohort
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Claudia Kunze contact
12 sites in 1 country
Germany12 sites
Charité University, Berlin, Germany
Berlin, State of Berlin, 10117
Claudia Kunze, +49-30-450-560628, c.kunze@charite.de
Lucia Kerti, lucia.kerti@charite.de
Universität Bielefeld, Universitätsklinikum OWL, Evangelisches Klinikum Bethel gGmbH,
Bielefeld, 33617
Wolf-Ruediger Schaebitz
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Hagen Huttner
Universitätsklinikum Erlangen
Erlangen, 91054
Stefan Schwab
Universitätsklinikum Essen
Essen, 45147
Martin Koehrmann
Simone Schwarz
Universitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg, Free and Hanseatic City of Hamburg, 20246
Johanna-Luise Kanwisch, +49-152-22803863, j.kanwisch@uke.de
Goetz Thomalla
Universitätsklinikum Heidelberg
Heidelberg, 69120
Jan Purrucker
Christian Gille (Paediatrics)
Universitätsklinikum Leipzig
Leipzig, 04103
Dominik Michalski
Universitätsklinikum Schleswig-Holstein (UKSH), Campus Lübeck
Lübeck, 23538
Folke Brinkmann (Paediatrics)
Ludwig Maximilians Universität Klinikum
München, 81377
Anna Kopczak
Lucia Gerstl (Paediatrics)
Universitätsklinikum Tübingen
Tübingen, 72076
Annerose Mengel
Universitätsklinikum Würzburg
Würzburg, 97080
Christian Hametner
Christoph Haertel (Paediatrics)
About this study
Official title: Master Study Protocol for the Cohort of the Specialist Network Stroke (SN Stroke) (Stroke-CORE)
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.
Read more
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.
- Keywords
- Stroke, ischemic stroke, Intracerebral Hemorrhage, Paediatric Stroke, Cerebrovascular Disorders, Brain Diseases, Vascular Diseases, Cardiovascular Diseases, Brain Infarction, Embolic Stroke, Thrombotic Stroke, Acute
- Medical subject headings
- Cerebral Hemorrhage, Stroke, Ischemic Stroke, Cerebrovascular Disorders, Brain Diseases, Vascular Diseases, Cardiovascular Diseases, Brain Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Stroke | 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/). | |
| Intracerebral Hemorrhage | 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. | |
| Paediatric Stroke | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start27 Jul 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HaemorrhageStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,750 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, University Hospital Schleswig-Holstein, Wuerzburg University Hospital
- Responsible party
- Principal investigator, Karen Gertz, Charite University, Berlin, Germany
- Investigators
- Karen Gertz, Full professor, MD, Principal investigator, Charite University, Berlin, GermanyGoetz Thomalla, Full professor, MD, Principal investigator, Universtätsklinikum Hamburg Eppendorf, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553650
- Sponsor's protocol ID
- DRKS00039775
- Other IDs
- 01KX2524, DRKS00039775
- Acronym
- Stroke-CORE
- Status last verified
- Jul 2026
- First submitted
- 13 Apr 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Poli S, Grohmann C, Wenzel DA, Poli K, Tunnerhoff J, Nedelmann M, Fiehler J, Burghaus I, Lehmann M, Glauch M, Schadwinkel HM, Kalmbach P, Zeller J, Peters T, Eschenfelder C, Agostini H, Campbell BC, Fischer MD, Sykora M, Mac Grory B, Feltgen N, Kowarik M, Seiffge D, Strbian D, Albrecht M, Alzureiqi MS, Auffarth G, Bazner H, Behnke S, Berberich A, Bode F, Bohmann FO, Cheng B, Czihal M, Danyel LA, Dimopoulos S, Pinhal Ferreira de Pinho JD, Fries FN, Gamulescu MA, Gekeler F, Gomez-Exposito A, Gumbinger C, Guthoff R, Hattenbach LO, Kellert L, Khoramnia R, Kohnen T, Kurten D, Lackner B, Laible M, Lee JI, Leithner C, Liegl R, Lochner P, Mackert M, Mbroh J, Muller S, Nagel S, Prasuhn M, Purrucker J, Reich A, Mundiyanapurath S, Royl G, Salchow DJ, Schafer JH, Schlachetzki F, Schmack I, Thomalla G, Tieck Fernandez MP, Wakili P, Walter P, Wolf A, Wolf M, Bartz-Schmidt KU, Schultheiss M, Spitzer MS. Early REperfusion therapy with intravenous alteplase for recovery of VISION in acute central retinal artery occlusion (REVISION): Study protocol of a phase III trial. Int J Stroke. 2024 Aug;19(7):823-829. doi: 10.1177/17474930241248516. Epub 2024 Jun 25.
PubMed 38591748Uhe T, Wasser K, Weber-Kruger M, Schabitz WR, Kohrmann M, Brachmann J, Laufs U, Dichgans M, Gelbrich G, Petroff D, Prettin C, Michalski D, Kraft A, Etgen T, Schellinger PD, Soda H, Bethke F, Ertl M, Kallmunzer B, Grond M, Althaus K, Hamann GF, Mende M, Wagner M, Groschel S, Uphaus T, Groschel K, Wachter R; Find-AF 2 study group. Intensive heart rhythm monitoring to decrease ischemic stroke and systemic embolism-the Find-AF 2 study-rationale and design. Am Heart J. 2023 Nov;265:66-76. doi: 10.1016/j.ahj.2023.06.016. Epub 2023 Jul 7.
PubMed 37422010Rimmele DL, Schrage T, Brettschneider C, Engels A, Gerloff C, Harter M, Rosenkranz M, Schmidt H, Kriston L, Thomalla G. Rationale and design of an interventional study of cross-sectoral, coordinated treatment of stroke patients with patient-orientated outcome measurement (StroCare). Neurol Res Pract. 2021 Feb 2;3(1):7. doi: 10.1186/s42466-021-00107-2.
PubMed 33526148Stahl B, Darkow R, von Podewils V, Meinzer M, Grittner U, Reinhold T, Grewe T, Breitenstein C, Floel A. Transcranial Direct Current Stimulation to Enhance Training Effectiveness in Chronic Post-Stroke Aphasia: A Randomized Controlled Trial Protocol. Front Neurol. 2019 Oct 22;10:1089. doi: 10.3389/fneur.2019.01089. eCollection 2019.
PubMed 31695667NAKO. (2025). Level 3 Projekte - NAKO Gesundheitsstudie. Retrieved 19.01.2026 from https://nako.de/forschung/forschungsprojekte/level-3-projekte/
Wachter R, Weber-Kruger M, Hamann GF, Kermer P, Liman J, Mende M, Seegers J, Wasser K, Groschel S, Uphaus T, Poppert H, Kohrmann M, Zabel M, Laufs U, Heuschmann PU, Conen D, Groschel K; Find-AFRANDOMISED Investigators and Coordinators. Long-Term Follow-up of Enhanced Holter-Electrocardiography Monitoring in Acute Ischemic Stroke. J Stroke. 2022 Jan;24(1):98-107. doi: 10.5853/jos.2021.01207. Epub 2021 Dec 17.
PubMed 34911255Vanassche T, Lauw MN, Eikelboom JW, Healey JS, Hart RG, Alings M, Avezum A, Diaz R, Hohnloser SH, Lewis BS, Shestakovska O, Wang J, Connolly SJ. Risk of ischaemic stroke according to pattern of atrial fibrillation: analysis of 6563 aspirin-treated patients in ACTIVE-A and AVERROES. Eur Heart J. 2015 Feb 1;36(5):281-7a. doi: 10.1093/eurheartj/ehu307. Epub 2014 Sep 3.
PubMed 25187524Turc G, Hadziahmetovic M, Walter S, Churilov L, Larsen K, Grotta JC, Yamal JM, Bowry R, Katsanos AH, Zhao H, Donnan G, Davis SM, Hussain MS, Uchino K, Helwig SA, Johns H, Weber JE, Nolte CH, Kunz A, Steiner T, Sacco S, Ebinger M, Tsivgoulis G, Fassbender K, Audebert HJ. Comparison of Mobile Stroke Unit With Usual Care for Acute Ischemic Stroke Management: A Systematic Review and Meta-analysis. JAMA Neurol. 2022 Mar 1;79(3):281-290. doi: 10.1001/jamaneurol.2021.5321.
PubMed 35129584Thomalla G, Simonsen CZ, Boutitie F, Andersen G, Berthezene Y, Cheng B, Cheripelli B, Cho TH, Fazekas F, Fiehler J, Ford I, Galinovic I, Gellissen S, Golsari A, Gregori J, Gunther M, Guibernau J, Hausler KG, Hennerici M, Kemmling A, Marstrand J, Modrau B, Neeb L, Perez de la Ossa N, Puig J, Ringleb P, Roy P, Scheel E, Schonewille W, Serena J, Sunaert S, Villringer K, Wouters A, Thijs V, Ebinger M, Endres M, Fiebach JB, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Gerloff C; WAKE-UP Investigators. MRI-Guided Thrombolysis for Stroke with Unknown Time of Onset. N Engl J Med. 2018 Aug 16;379(7):611-622. doi: 10.1056/NEJMoa1804355. Epub 2018 May 16.
PubMed 29766770Thomalla G, Boutitie F, Ma H, Koga M, Ringleb P, Schwamm LH, Wu O, Bendszus M, Bladin CF, Campbell BCV, Cheng B, Churilov L, Ebinger M, Endres M, Fiebach JB, Fukuda-Doi M, Inoue M, Kleinig TJ, Latour LL, Lemmens R, Levi CR, Leys D, Miwa K, Molina CA, Muir KW, Nighoghossian N, Parsons MW, Pedraza S, Schellinger PD, Schwab S, Simonsen CZ, Song SS, Thijs V, Toni D, Hsu CY, Wahlgren N, Yamamoto H, Yassi N, Yoshimura S, Warach S, Hacke W, Toyoda K, Donnan GA, Davis SM, Gerloff C; Evaluation of unknown Onset Stroke thrombolysis trials (EOS) investigators. Intravenous alteplase for stroke with unknown time of onset guided by advanced imaging: systematic review and meta-analysis of individual patient data. Lancet. 2020 Nov 14;396(10262):1574-1584. doi: 10.1016/S0140-6736(20)32163-2. Epub 2020 Nov 8.
PubMed 33176180Stockert A, Wawrzyniak M, Klingbeil J, Wrede K, Kummerer D, Hartwigsen G, Kaller CP, Weiller C, Saur D. Dynamics of language reorganization after left temporo-parietal and frontal stroke. Brain. 2020 Mar 1;143(3):844-861. doi: 10.1093/brain/awaa023.
PubMed 32068789Stahl B, Millrose S, Denzler P, Lucchese G, Jacobi F, Floel A. Intensive Social Interaction for Treatment of Poststroke Depression in Subacute Aphasia: The CONNECT Trial. Stroke. 2022 Dec;53(12):3530-3537. doi: 10.1161/STROKEAHA.122.039995. Epub 2022 Sep 20.
PubMed 36124755Schwarzbach CJ, Eichner FA, Rucker V, Hofmann AL, Keller M, Audebert HJ, von Bandemer S, Engelter ST, Geis D, Groschel K, Haeusler KG, Hamann GF, Meisel A, Sander D, Schutzmeier M, Veltkamp R, Heuschmann PU, Grau AJ; SANO study group. The structured ambulatory post-stroke care program for outpatient aftercare in patients with ischaemic stroke in Germany (SANO): an open-label, cluster-randomised controlled trial. Lancet Neurol. 2023 Sep;22(9):787-799. doi: 10.1016/S1474-4422(23)00216-8. Epub 2023 Jul 14.
PubMed 37459876Salinas J, Sprinkhuizen SM, Ackerson T, Bernhardt J, Davie C, George MG, Gething S, Kelly AG, Lindsay P, Liu L, Martins SC, Morgan L, Norrving B, Ribbers GM, Silver FL, Smith EE, Williams LS, Schwamm LH. An International Standard Set of Patient-Centered Outcome Measures After Stroke. Stroke. 2016 Jan;47(1):180-6. doi: 10.1161/STROKEAHA.115.010898. Epub 2015 Nov 24.
PubMed 26604251Nolte CH, von Rennenberg R, Litmeier S, Leistner DM, Szabo K, Baumann S, Mengel A, Michalski D, Siepmann T, Blankenberg S, Petzold GC, Dichgans M, Katus H, Pieske B, Regitz-Zagrosek V, Braemswig TB, Rangus I, Pepic A, Vettorazzi E, Zeiher AM, Scheitz JF, Wegscheider K, Landmesser U, Endres M. Type 1 Myocardial Infarction in Patients With Acute Ischemic Stroke. JAMA Neurol. 2024 Jul 1;81(7):703-711. doi: 10.1001/jamaneurol.2024.1552.
PubMed 38829625